Can Stem Cells Treat Lyme Disease?

By A. Rahman Ford, PNN Columnist

In a recent article in Scientific American, author Mary Beth Pfeiffer paints a startling portrait of Lyme disease in America.  She describes the “peril and menace” now associated with many forests, parks and even some backyards -- landscapes that Lyme disease-carrying ticks inhabit in ever-increasing numbers. 

“Although children are the most frequently diagnosed group and thousands of infected patients develop long-term infirmity every year, little has been done to curb the spread of the ticks,” Pfeiffer wrote. 

According to the article, the primary reason for the explosion in Lyme disease is that mainstream medicine continues to labor under the long-disproven myth that the disease is easy to diagnose and treat.  In truth, diagnosis is complex, and treatment options are woefully inadequate and sometimes even dangerous. 

According to the Centers for Disease Control and Prevention , Lyme disease is the most common vector-borne illness in the U.S.  It is transmitted by the bite of a blacklegged tick, or deer tick, that is infected with Borrelia burgdorferi or Borrelia mayonii bacteria. 

Deer ticks tend to thrive in woody or grassy areas.  Although most cases are reported from northeastern states like New Jersey, Connecticut and Maryland, states like Minnesota and Wisconsin have also reported cases. The geographic distribution seems to be expanding, along with an increase in the number of counties reporting Lyme cases.

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In 2016, there were over 36,000 confirmed or probable cases of Lyme disease, although the actual number may be ten times as high. Common symptoms include a small red bump at the site of the tick bite, which can expand into a rash that forms into a bull’s-eye pattern.  Flu-like symptoms are also common. 

If Lyme disease is left untreated, multiple symptoms may emerge which may be dermatological, musculoskeletal, neurological and/or cardiovascular in nature.  Symptoms can include severe joint pain and swelling, meningitis (swelling of the brain), paralysis, numbness, weakness of the limbs and impaired muscle movement.  These symptoms can last for months or even years.  Because they tend to mimic the symptoms of other diseases, Lyme is often misdiagnosed.

There is no consistently reliable test for Lyme disease and diagnosing it can be tricky.  Oftentimes, patients do not present with a rash or any other common symptoms.  Laboratory tests, like enzyme-linked immunosorbent assay (ELISA), which are designed to detect bacterial antibodies, can give false positives.  And the Western Blot test, used to confirm ELISA results, has no standard criteria for interpretation.

Treatment for Lyme disease is likewise problematic.  The standard course of treatment is a 14 to 21 day course of oral antibiotics.  If the patient presents with neurological symptoms, intravenous administration may be preferred.  According to the Mayo Clinic,  “after treatment, a small number of people still have symptoms, such as muscle aches and fatigue,  the cause of these continuing symptoms, known as post-treatment Lyme disease syndrome, is unknown, and treating with more antibiotics doesn’t help.”

However, many holistic practitioners disagree, contending that the number of patients with post-treatment symptoms is far larger than estimated, and an extended course of antibiotics – or other treatment modalities – may be warranted.  Several of these physicians have had their licenses revoked, faced other disciplinary actions for ethics violations, or even been sent to prison.

Stem Cells and Lyme Disease

Given that the standard course of treatment fails many Lyme disease patients, alternative therapies are needed.  Stem cells may be a viable option to treat symptoms associated with Lyme disease syndrome because they are inflammatory in nature.  Mesenchymal stem cells, which may be readily obtained from bone marrow or adipose (fat) tissue, are known to possess immunomodulatory properties.  This means they could potentially lower inflammation and resolve the stubborn persistent Lyme symptoms that refuse to respond to conventional antibiotic therapies. 

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KELLY OSBOURNE

Although the evidence for the efficacy of stem cell therapy in treating Lyme disease is largely anecdotal, the stories are compelling.

In one high-profile case, former E!’s Fashion Police host and Project Runway Junior judge Kelly Osbourne details her experience with Lyme disease in her memoir.  

In 2004, Osbourne was bitten by a tick from a reindeer at her father Ozzy’s 56th birthday party.  As a result of the bite, she suffered for a decade with “traveling pain” from a sore throat and stomach aches, which eventually led to a seizure on the set of Fashion Police.

 Osbourne was later diagnosed with epilepsy and prescribed drugs that, in her words, “turned her into a zombie.”  She went from taking Ambien to Trazodone to painkillers to anxiety medication.

After visiting an alternative medical practitioner, Osbourne tested positive for Lyme disease.  Rather than try to treat the disease with antibiotics, she went to Germany for stem cell therapy.  That therapy was a success.  In her words, “I was experiencing emotions and feelings again.” 

Osbourne initially kept quiet about what she calls her “cure” because she feared retribution from pharmaceutical companies.  She has since become an advocate for stem cell therapy.

Patients suffering from chronic Lyme disease need options.  Stem cell therapy could be one of them.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

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Taking Stem Cells to the Bank

By A. Rahman Ford, Columnist

There’s a lot of hope and hype surrounding stem cells – the latest being the idea of “banking” them -- harvesting and storing your own stem cells for future use.

A biotech start-up called Forever Labs maintains that young adults have healthier cells that can be used when they are older to fight arthritis and other age-related diseases – or perhaps even help them live longer with a booster shot of younger cells. 

“Research suggests the decline in the number and viability of bone marrow stem cells plays a role in the physical decline associated with aging. In fact, simply injecting genetically-matched young stem cells into aged mice significantly increases their lifespan,” the company claims on its website. “To have access to young, genetically-matched stem cells in the future, store yours today.

Collection of bone and bone marrow stem cells is done by a Forever Labs physician in a 15-minute out-patient procedure that costs about $2,000.  Your cells are then cryogenically frozen and stored for $250 a year.  

Another company, called LifeVault, offers a similar service at a lower price: $995 to have a blood sample drawn and shipped to a lab in New Jersey, where the blood will be processed into stem cells and stored for $95 a year. 

“We believe, and medicine is starting to believe, that this is really going to be a part of your health hygiene,” LifeVault CEO Trevor Perry told STAT News. He called the company’s test kit a form of “biological insurance.”

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“You insure a lot of things in your life, but have you taken out a policy on yourself?” Perry asked.

LifeVault and Forever Labs are indicative of a larger trend in the fast-growing stem cell industry. As hundreds of stem cell clinics have opened around the country – offering treatment for everything from back pain to neuropathy – stem cell banking has moved beyond its original use for research toward commercialization for everyday people.  

The global stem cell banking market is projected to reach $9.3 billion by 2023, according to the research firm MarketsandMarkets, with the personalized banking segment projected to account for most of that growth.

In addition to blood and bone marrow, stem cells from a variety of other sources can be banked, including dental tissue, umbilical cord blood, placental tissue, adipose fat tissue and fetal tissue.

Umbilical cord blood and adipose tissue are currently the most commonly banked sources of stem cells.  This is largely because of practical concerns such as low cost, ease of access to the tissue, and the ability to harvest large amounts of stem cells.  

Cord blood contains primarily hematopoietic stem cells, along with a mixture of other cell types that may be suitable for treating certain rare genetic diseases.  Adipose tissue contains an abundance of mesenchymal stem cells (MSCs), a type of stem cell with immune and regenerative capabilities.  Both types have been used to treat orthopedic, neurological and cardiovascular conditions.

Several factors impact the use of cells stored in stem cell banks.  First, the source of the stem cells must be taken into consideration.  Autologous stem cells --- which come from the patient being treated -- are easier from a medical and regulatory point of view because the risk of immune system rejection is lower, as is the risk of running afoul of FDA regulations. 

Methods of collection and processing are also critical.  In the case of cord blood, most companies use small bags to collect the blood at the time of birth. Cord tissue can also be collected, stored and used later for regenerative purposes.  

Adipose tissues are obtained through liposuction procedures or by syringe under local anesthetic.  The adipose fat must be processed and preserved within 36 hours of harvesting.  The material is washed with saline and ultimately stored in a liquid nitrogen freezer.  

While still relatively new, stem cell banking is poised for healthy growth.  That growth is buttressed by the unfortunate rise in chronic diseases among both children and adults.  Growth and competition should also result in lower costs, a factor which surely deters many interested clients from taking out that “biological insurance” policy on themselves. 

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A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

TV Host Tries Stem Cell Therapy for Chronic Back Pain

Reality TV star Tarek El Moussa – host of HGTV’S “Flip or Flop” – recently posted photos on Instagram detailing his experience with stem cell therapy. 

El Moussa has a history of back injuries causing severe pain. He lost 50 pounds while recovering from one back injury and was taking “large amounts of pain meds to try and help the pain.” 

“Truthfully those meds really affected my mental and physical state and changed who I was,” El Moussa posted.

When he recently injured his back again and could “barely walk,” El Moussa decided stem cell therapy was a better option. In one photo of the stem cell procedure, El Moussa shows a 12-inch needle being inserted into his lower back to remove fat cells, a procedure similar to liposuction.

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TAREK EL MOUSSA

“I believe they put over 1,000,000 stem cells back in my body after the lipo. It's wild seeing the technology and future of medicine,” he wrote.

A post-operative photo shows El Moussa’s discolored and bruised lower back three days later. He said he was still “a little sore” but that his back was “actually feeling better!” He’s hoping for a “major improvement” from the procedure in a few weeks.

El Moussa’s therapy involved a controversial stem cell product known as stromal vascular fraction (SVF).  It’s the same product at the center of two lawsuits recently filed by the Department of Justice on behalf of the FDA against stem cell clinics in Florida and California.

What is Stromal Vascular Fraction?

SVF uses autologous stem cells derived from a patient’s own body, including adipose (fat) cells obtained through liposuction.  When injected back into the body, these stem cells stimulate the immune system, have anti-inflammatory properties, and promote the development of new blood vessels. All help to heal injured tissues.

For clinicians, the attraction of SVF is that the procedure is “point of care” or delivered at the time of care.  In theory, this would exempt the therapy from FDA rules for stem cell products under the “same surgical procedure” exception.  The FDA, however, doesn’t agree with that interpretation and has yet to approve SVF use. It considers the procedure unproven and experimental. But that hasn’t stopped dozens of stem cell clinics from offering SVF therapy.

SVF generally has a good safety profile.  Potential risks of SVF therapy include lack of standardization of SVF products and terminology, unwanted tissue differentiation, poor cell handling and insufficient data on dose versus effect. 

Evidence regarding the clinical efficacy of SVF in treating painful conditions is limited.  Jaewoo Pak, MD successfully treated patients with knee osteoarthritis.  Their pain scores, functional ability and cartilage regeneration were all improved through SVF therapy.  Pak also achieved success in treating meniscus tears and osteoarthritis of the hip.  

In 2015, three researchers for the Cell Surgical Network (who are defendants in the FDA lawsuits) reported on their treatment of 1,524 patients with SVF who lived with painful conditions such as osteoarthritis.  About 25% of the patients showed evidence of new cartilage formation in their joints and 80% had a significant reduction in pain.  The beneficial effects of SVF were sustained for well over six months and some for several years.  The researchers also reported success in treating neurodegenerative diseases, with 80% of the patients with interstitial cystitis showing pain reduction.

Despite the controversy and lawsuits, El Moussa and thousands of other patients are willing to give SVF therapy a try. We’ll keep you updated on his progress.

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A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Seeks Shutdown of Stem Cell Clinics

By Pat Anson Editor

The U.S. Food and Drug Administration has stepped up its crackdown on the stem cell industry by filing two complaints in federal court seeking permanent injunctions against stem cell clinics in Florida and California.

US Stem Cell of Sunrise, Florida and California Stem Cell Treatment Center are accused of marketing stem cell products without FDA approval and for “significant deviations” from safety and manufacturing guidelines. Both companies said they would “vigorously defend” themselves and challenge the FDA’s authority to regulate autologous stem cells, which are made from a patient’s own blood or tissue.

The  lawsuits could ultimately decide the fate of hundreds of stem cell clinics that have opened around the country in recent years, offering new therapies for arthritis, neuropathy, degenerative disc disease and other chronic conditions.

“Cell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk. In some instances, patients have suffered serious and permanent harm after receiving these unapproved products,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

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In 2015, three elderly women became legally blind after having unapproved stem cell treatments for macular degeneration at US Stem Cell. The clinic was also warned by the FDA last year to stop using adipose tissue (body fat) to make stem cells that were injected into the spinal cords of patients.

The FDA alleges that California Stem Cell Treatment Center – which has clinics in Beverly Hills and Rancho Mirage -- is also using stem cells derived from adipose tissue to treat patients suffering from arthritis, stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), diabetes, cancer and other conditions.

“The unproven and potentially dangerous treatment was being injected intravenously and directly into patients’ tumors,” the FDA said.

The case against California Stem Cell could have a broad impact because it also targets the Cell Surgical Network Corporation (CSN), which has a chain of about 100 stem cell clinics. At issue in both lawsuits is whether a patient’s own stem cells can be used for therapeutic purposes and are outside the control of federal agencies like the FDA.

“CSN strongly rejects the idea that a person’s own cells should be regulated by FDA as a drug,” Dr. Elliot Lander of CSN and California Stem Cell Treatment Center said in an email to The Niche, a stem cell blog.

“We share FDA’s concern for patient safety, but do not believe that FDA regulation of a surgical procedure that simply harnesses the healing power of a patient’s own cells, without altering the biological characteristics of those cells, is the answer. The decision of whether or not the surgical procedure is performed should be made by the patient and physician – not the FDA or any other arm of the federal government.”

US Stem Cell also released a statement on its website, saying it would “vigorously defend medical freedom of Americans.”

Stem Cell Therapy Becoming More Affordable

By Dr. Kristin Comella, Guest Columnist

Demand for stem cell therapy in the U.S. is anticipated to be at an all-time high this year as more patients seek to use their own cells to heal from various injuries and diseases. Among them are many chronic pain patients seeking alternatives to opioid medication and surgery for treating pain caused by systemic diseases, orthopedic conditions, neurological problems and aging.

At one time many patients traveled outside the country and were paying $20,000 to $50,000 for treatment at stem cell clinics in Europe and Asia. But over the past five years, the cost of stem cell therapy has come down dramatically.

Stem cell providers have been able to simplify the process into an outpatient protocol at hundreds of clinics throughout the U.S. As a result, costs are lower -- typically from $5,000 to $12,000 -- depending on the specific condition, practitioner, location and treatments required.

As with any specialized procedure, the cost will reflect the depth of the treatment and the time spent working with the patient. Unfortunately, stem cell treatments are not usually covered by insurance.

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When compared to traditional surgery, where in most cases there is a similar price point and significant down-time, out-patient stem cell therapy is much less invasive. Patients treated with stem cells can return to their regular routines soon after the simple procedure, rather than requiring weeks of physical therapy or needing crutches and wheelchairs to get around.

Recent studies show that stem cells may be used in a variety of indications where opioids are frequently prescribed, such as back pain.  I recently co-authored a small study appearing in the Journal of Translational Medicine, in which 15 patients with degenerative disc disease were treated with stem cells derived from their own fat tissue. All 15 patients reported a statistically significant reduced pain level after stem cell therapy.

Adult stem cells may have the ability to improve and possibly even reverse the effects of many types of chronic pain caused by tissue or neurological damage. Adult stem cells are found in every part of the body, and can be harvested from a patient’s own tissue, such as adipose (fat) tissue, muscle, teeth, skin or bone marrow. Fat tissue is one of the most plentiful sources of stem cells in the body. In fact, approximately 500 times more stem cells can be obtained from fat than bone marrow.

Typically, during a simple outpatient procedure, stem cells can be isolated from fat tissue in 30 to 90 minutes, under local anesthesia using a mini-lipoaspirate technique. They can then be infused or re-injected after the mini-liposuction.

A recent study published in the Journal of Clinical Medicine Research underscores the safety of using a person’s own stem cells – known as autologous stem cells -- in treating degenerative diseases and injuries. The study was the largest safety trial to date that successfully used stem cells from fat in procedures completed on 676 patients. It is also the first trial to address cells from fat in multiple diseases and with different delivery routes.

To date, more than 10,000 patients have been successfully treated using the stem cell protocols being utilized at American Stem Cell.  There has been a significant increase in interest from patients in using stem cells for general health, anti-aging, and reducing inflammation. More and more patients are also seeking to preserve and bank their cells for “just in case” scenarios.

The positive results we’ve been getting are very encouraging and offer hope for many patients battling chronic pain. 

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Kristin Comella, PhD, is Chief Science Officer for American Stem Cell Centers of Excellence. She specializes in regenerative medicine with a focus on adipose derived stem cells.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Moves Forward on Stem Cells

By A. Rahman Ford, Columnist

The Food and Drug Administration is finally getting the message.

In a special report published in The New England Journal of Medicine, the FDA makes a clear and positive shift in its stem cell policy – conceding that the old paradigm of drug approval just doesn’t work for stem cells.

The report, entitled “Balancing Safety and Innovation for Cell-Based Regenerative Medicine” is authored by FDA Commissioner Scott Gottlieb, MD, and Peter Marks, MD, Director of the FDA’s Center for Biologics Evaluation and Research. 

Although short on specifics, Gottlieb and Marks declare their openness to creating alternative paths toward FDA approval of stem cell products – a policy change that could help stem cell therapies get to market faster and help patients sooner. This is a welcome move by the FDA. 

The tone used by the authors signals that the FDA is listening to the voice of the people and stem cell developers. Gottlieb and Marks wrote the FDA must take “an original policy approach to the regulation of a highly innovative field, one in which [the FDA’s] traditional approach to regulation may not be as efficient or effective as in more mature fields.” 

They maintain further that by working “within the existing regulatory framework” and by adopting “new principles,” the FDA’s premarket evaluation of stem-cell therapies will become more efficient. 

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It seems the agency could no longer ignore the fact that patients – such as those who suffer from chronic pain – cannot wait for the rusty gears of the antiquated clinical trial process to churn out the treatments they need to save their lives.

FDA Breaks with Past

The tone set by Marks and Gottlieb differs significantly from that of Gottlieb’s predecessor, Robert Caliiff, MD, who co-authored a NEJM article last year entitled “Clarifying Stem Cell Therapy’s Benefits and Risks.”  As I’ve previously discussed, the arguments made by Califf were seriously problematic, specifically with regard to autologous therapies, which use stem cells made from a patient’s own blood or body tissue  

Although Califf and his co-authors acknowledged the “unique challenges of stem cell clinical research,” their overall posture was decisively rigid in regard to new approaches to FDA approval.  As an indication of just how low of a priority outreach was to them, they made no mention of working with stem cell investigators and sponsors until the final sentence of the article.  For the previous regime, outreach was an afterthought.

Marks and Gottlieb seem to be taking a more conciliatory approach by extending a regulatory olive branch to stem cell physicians and small clinics.  Unlike previous FDA statements, they spent less time on the spurious issue of safety and instead pivot toward the effectiveness of treatment and moving forward with commercialization.  In doing so, the they acknowledge that the novelty of stem cell technologies require a more flexible path toward approval.

To accommodate this move and to facilitate the expedited availability of stem cells to patients, the FDA will use the expanded authorities granted it by the 21st Century Cures Act.  The Cures Act allows the FDA to use non-traditional types of data – such as clinical data – to receive FDA approval.  Notably, the FDA will be incorporating some “new concepts for how small investigators and firms can seek and meet the approval standard for products through efficient expedited pathways.”  This is a step in the right direction.

How exactly will this work in practice?  No one really knows.  Marks and Gottlieb only provide one theoretical example: the FDA will provide “tools” to allow small firms to work collaboratively to obtain a biologics license for physicians, researchers and clinics.

Any outreach by the FDA should be welcomed and any attempt to expedite the availability of stem cell therapies to patients who need them should be encouraged.  However, given the dearth of detail offered by Gottlieb and Marks, precisely how these alternatives will work in practice remains nebulous.  Thus, the overtures made by the FDA are – at this point -- best met with skepticism and a cautious optimism

If the FDA is truly open to novel approaches to stem cell regulation, it should devise separate rules for autologous therapies – which former Commissioner Califf acknowledged “raise fewer safety concerns than allogenic cells.”  Regulation of autologous therapies by the FDA should be minimal, with the majority of oversight left to state governments and their agencies.

These new policy changes by the FDA are forward-thinking and should proceed further.  However, as promising as those options appear, they should in no way be construed as delegitimizing or nullifying legislative advances made in Texas or those that will be made when Congress enacts “Right to Try” legislation. 

All of these options can function cooperatively to ensure that the patients – often the most overlooked quantity in the medical policy equation – can receive the life-saving and curative treatments they need as soon as possible.

The FDA may offer many paths, but it need not be the only path.

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A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Should the ‘War on Stem Cells’ Be Fought in Court?

By A. Rahman Ford, Columnist

A recent article published in the journal Regenerative Medicine suggests that civil lawsuits should be used to protect patients and draw attention to unscrupulous stem cell clinics. 

The authors, Claire Horner, Evelyn Tennenbaum, Zubin Master and Douglas Sipp, contend that civil litigation would "convincingly show patients and society that there are real and significant harms from unproven SCIs (stem cell interventions), and this strategy may complement the arsenal of efforts focused on reining in this industry.” 

Horner, Tennenbaum and Master are academics in medical ethics at Baylor College of Medicine, Albany Law School and the Mayo Clinic, respectively; while Sipp is affiliated with RIKEN, a Japanese research institute that is developing stem cell technology.

Their use of the word “arsenal” sounds like a declaration of war, an unfortunate, fratricidal war against their fellow Americans who need stem cells to treat their pain and disability.  After reading their article, it’s clear that fearmongering is their best weapon.

The authors really don’t like clinics that use a patient’s own stem cells to heal themselves.  They lament that many industrialized countries are moving toward more openness in accelerated approval of stem cells and other regenerative therapies.  And they contend that inadequate enforcement and penalties at the U.S. federal level justify the need for lawsuits.

“In the absence of government oversight of private sector firms, patients and consumers may need to look elsewhere to protect their interests. Civil litigation provides a means for patients who feel they have been harmed by undergoing a SCI to seek redress and compensation from providers and may also motivate government and industry to address the issue on a larger scale,” they wrote.

The most stupefying part is that the authors go so far as to compare the issue to tobacco companies, gun violence and child molestation! 

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The authors admit at the outset that the main goal of their campaign is to propagandize the public and policy-makers.  They state plainly that “stem cell lawsuits may help raise public awareness and influence public policy” and would help draw “attention to negative outcomes and engender moral outrage on the behalf of vulnerable and sympathetic plaintiffs.” 

This tactic would shift attention away from pesky patients’ rights advocates who support broader availability of the potentially life-saving treatments offered by stem cells.  They see this strategy as viable because it worked for consumers injured by the tobacco industry, victims of gun violence, and sexual abuse victims molested by Catholic priests.  The fact that the authors would put stem cell clinics – and by extension stem cell patients – in the same category as Philip Morris, AR-15 gun manufacturers and pedophile Catholic priests is simply ludicrous.

For the authors, civil litigation is essentially a propaganda tool in their misguided war against a non-existent enemy. They advocate using civil litigation to “attract public attention” and “shape the media narrative.” Information operations such as these are an age-old concept in international relations and warfare, that includes the collection of tactical information about an adversary as well as the dissemination of propaganda in the pursuit of a competitive advantage over an opponent. 

And how do the authors intend to collect their tactical information?  They will use the civil litigation discovery process to uncover “previously undisclosed information about a provider’s practices” that could potentially trigger FDA investigations. 

Overall, the tone of the authors’ proposal is that of combativeness and belligerence, not negotiation and reconciliation.  As with all misguided wars, it is civilians – those who the war is allegedly waged to protect – are the ones who suffer the most.

Little Evidence to Support ‘War on Stem Cells’

Even worse, they don’t show their “war on stem cells” is supported by any real-world evidence.  Their methodology is insufficiently rigorous; it lacks integrity to the point of being flimsy, porous and leaky.  The data which serve as the cornerstone of the authors’ argument are 9 court cases in which plaintiffs allege that the stem cell therapy they received was either ineffective or injurious.  

This sample is far too small to seriously support any meaningful conclusions, much less the authors’ conclusion that the number of legal claims is growing.  The 9 cases cited were filed between 2012 and 2017 for a wide variety of medical conditions and for a wide variety of causes of action.

Not only are we not told how many stem cell procedures were actually performed in American clinics over the same time span, but in none of the 9 cases cited was there a disposition in favor of the plaintiffs!  In fact, one was voluntarily dismissed by the plaintiffs and another was dismissed on appeal.  Of the remaining seven, 4 were settled and 4 have yet to be decided. 

So none of the claims of negligence, misrepresentation, fraud, lack of informed consent, or unfair trade practices were ever proven.  The authors acknowledge that this is a problem, and in desperation turn to a Japanese case to support their claims.  The problem is the authors openly admit that “the U.S. administrative and legal systems differ greatly from Japan’s.”  It’s never a good idea to undermine your own argument.

If the authors are truly motivated by the safety and welfare of stem cell patients, then perhaps their efforts would be better spent advocating for the increased democratization and liberalization of stem cell policy. 

This can be accomplished by supporting policies geared toward the availability and affordability of stem cell therapies, such as the patient-centered ethos of “Right to Try” legislation, the regenerative medicine provisions of the 21st Century Cures Act, and the constitutionally-protected privacy right in a patient’s use of their own stem cells. 

We need less antagonism and asymmetry in stem cell policy-making, and more alliance-building and acceptance of a new paradigm of progress. The solution is not more litigation against people, but more listening to the people.

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A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

How Trump and Congress Can Champion Stem Cells

By A. Rahman Ford, Columnist

For the second straight year, President Trump has endorsed making life-saving treatments like stem cell therapies more available to more Americans.

In his 2017 Joint Address to Congress, Trump highlighted the case of Megan Crowley, a young woman whose father had to launch his own drug company to help treat her Pompe Disease.  Also in attendance that evening was Sarah hughes, who was forced to travel to Mexico to use her own stem cells to treat her systemic idiopathic juvenile arthritis.

In reference to both cases, the president lamented the pain and death caused by the “slow and burdensome approval process at the Food and Drug Administration” that “keeps too many advances … from reaching those in need.”  He argued that regulatory restraints at the FDA should be “slashed” so that more Americans could benefit from life-saving therapies.

President Trump is keeping up the pressure.  During this week's State of the Union address, he continued his theme of a patient-centered, less restrictive approach to medical treatment. 

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He did so by voicing his clear support for “Right to Try” legislation, which would increase the medical options of the critically ill by helping them avoid the unduly burdensome and bureaucratic spider’s web of the FDA. 

In a seeming reference to Sarah Hughes and other stem cell medical tourists, Trump stated unequivocally that “patients with terminally conditions … should have access to experimental treatments immediately” and they “should not have to go from country to country to seek a cure.”  He then urged Congress to pass the Right to Try Act, so that Americans can get help “right here at home.”

How Right to Try Works

The language of the Right to Try legislation is simple, straightforward and offers protections for patients and manufacturers.  Under the Senate version, an “eligible patient” who has been diagnosed with a terminal illness may be prescribed an experimental drug or biological product to treat their illness, so long as the patient has a qualified physician certify that he or she has exhausted all other treatment options and is unable to participate in a clinical trial. The patient must also provide informed consent to the physician and the physician may not be compensated by the manufacturer of a treatment for certifying the patient.  The patient, physician and manufacturer must all agree on the treatment.

Furthermore, the medical product in question must have successfully completed a Phase 1 clinical trial and must be enrolled in an FDA clinical trial.  The treatment must be authorized by state law, which means that the state must have a Right to Try law – which 38 states currently have.

The manufacturers receive protection under Right to Try legislation, in that there can be no legal liability for injury that may result as a consequence of the medical product’s use, and adverse events that may occur during treatment will not negatively impact any eventual approval of the product by the FDA. 

In an overwhelming and increasingly rare bipartisan display (94-1), the Senate has already passed the Right to Try Act.  The House version is currently awaiting approval.

Critics Deny Democratic Choice 

Critics of Right to Try make several claims to undermine the expansion of choices it would bring to critically ill patients.  Some physicians and medical ethicists claim that the true goal of Right to Try is to weaken the FDA as the only objective and appropriate gatekeeper of drug approval and access.  Some also claim that the legislation is redundant because the FDA already fills this need through its expanded access program. 

Still other critics try to dissuade patients by surreptitiously noting that “scary” conservative and libertarian think tanks like Freedom Partners and Americans for Prosperity, which are partially funded by the Koch brothers, favor passage of Right to Try legislation.  These criticisms warrant thoughtful consideration, but are not substantive enough to overcome overarching concerns of patients literally dying from their pain.    

Ultimately, Right to Try and stem cell therapy are issues that embody the deepening and broadening of healthcare choice -- a choice that should be embraced by an informed American citizenry, a forward-thinking medical establishment and government agencies that must be by and for the people. 

Carefully curated expansions of choice -- that privilege the humane while also giving due consideration to patient protection – serve as the foundation of all truly democratic institutions.  The FDA should accept that it can better serve people by acceding some of its authority and become more lean and nimble in the process.  Bigger is not always better.

Right to Try will not solve all the problems associated with stem cell therapy.  There is no way to predict with any precision how the law will operate legally or logistically, whether for stem cell therapies or other drugs and medical products.  Additionally, the Trump administration must revisit and revise the FDA’s stem cell guidance, specifically its limits on stem cells which are harvested, processed and administered to the same person to relieve conditions such as chronic pain.    

However, for advocates of stem cell therapy and health choice in general, Right to Try is a step in the right direction.

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A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Stem Cell Regulation and a Rule Too Many

By A. Rahman Ford, Columnist

The New England Journal of Medicine recently published an op/ed rather benignly entitled “Rejuvenating Regenerative Medicine Regulation.”  

The authors, R. Alta Claro and Douglas Sipp, argue that the Food and Drug Administration did not go far enough in regulating stem cell therapies in its recently released final guidance, and that further restrictions need to be placed on Americans seeking to use their own cells to heal themselves. Both authors are affiliated with RIKEN, a Japanese research institute that is developing stem cell technology.

Although clothed in the flowing garb of humaneness, medical ethics and protecting the sick and disabled, the authors’ posture reveals itself to be strikingly paternalistic.  Rather than “rejuvenate” regenerative medicine with ideas that would invigorate and fertilize a forward-thinking, democratic regulatory regime, Claro and Sipp instead articulate positions so extreme that they operate as more of a death knell to stem cell innovation.  Indeed, the authors seem to have issued a eulogy for a promising and precocious corpus of medicine that has barely attained its infancy.

In their view, the FDA guidance is “a positive step,” but more needs to be done.  To assist in the effort, they urge institutions at the state level to “crack down” on malfeasant clinics and agitate for state legislatures to pass stricter informed consent laws, as was recently done in California. 

To justify further restrictions on the availability of stem cell therapies, they claim that the “explosion of stem cell marketing in the United States” has led to “predatory” clinics offering “untested stem cell treatments [that have] exposed patients to unjustifiable risks.” 

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They further claim that the FDA has fallen short in in its staged approach to enforcing the new rules against clinics deemed to be in violation.  The authors even go so far as to assail the 21st Century Cures Act because it created “a pathway to approval that is at risk of putting cell and tissue products on the market before they have been adequately tested.”

A bare endorsement of the FDA’s “minimal manipulation” and “homologous use” tests would have been troubling enough, and the authors do endorse those tests in their article.  As I wrote in an earlier column, the agency’s guidance is unduly burdensome when it comes to autologous therapies – which involve stem cells that are extracted from a person and administered to the same person to relieve conditions such as chronic pain. 

In Clara and Sipp’s view, those suffering from pain and other chronic illnesses are part of the problem, because it was largely “patient demand” that helped “drive the growth of unproven therapies.”  Such a placing of blame upon chronically ill patients is disappointing. 

Equally disappointing is the authors’ disregard of those same patients’ constitutionally-protected privacy interest in their own bodies and their own cells, an interest which – as with abortion rights – would require a compelling interest on the part of the federal government to justify excessive regulation.  Unfortunately, an uncited reference to “numerous documented reports of medical accidents” involving stem cells does not a compelling interest make.

Texas Should be the Model

However, the authors are correct that states must be more involved in setting stem cell policy.  The problem is that they chose the wrong example.  Rather than emulate the restrictive policies of California, the Texas example should be the model that other states follow.  Texas has passed legislation making autologous stem cell therapies more accessible to its residents and has even buttressed it with “right to try” legislation.  

The Texas effort was spearheaded by tireless patient advocates who were able to communicate to state lawmakers their truly human stories.  Lawmakers heard and felt that pain – some personally because of their own experiences with pain and disability.  The result was stem cell choice, in a state-led regulatory model that can hopefully be a nationwide blueprint, as Washington state was for marijuana legalization.

Stem cell policy-making must not be a strictly elite enterprise.  It must be democratic process, as embodied by the Congress when it overwhelmingly passed the Cures Act and its provisions which help expedite stem cell cures.  The people’s voice must be preponderant, and bolstered by thoughtful, reasonable rules that privilege choice, promote fairness, and protect us from physical and legal injury.

We should not seek rules that only preserve a place for the status quo in a rapidly advancing medical technology landscape that threatens to make a dusty relic out of old ways of thinking.  The orthodox "clinical trial" medical regulatory paradigm favored by the FDA simply does not work for regenerative medicine and stem cell therapies.  So rather than fear-mongering by focusing on a conjured-up phantom of rampant medical malfeasance, we should embrace the future. 

Fear of change is understandable and expected from certain quarters.  But the millions of Americans in chronic and intractable pain are not the ones who are afraid, and are not as docile and ignorant as they may be portrayed.

Although their argument is flawed, the title Charo and Sipp selected is resounding.  Regenerative medicine and stem cell policies must indeed be about rejuvenation, not more regulatory entanglement.

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A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

How Stem Cells Can Reverse Opioid Tolerance

By A. Rahman Ford, Columnist

On January 10, Pennsylvania Governor Tom Wolf declared a disaster emergency to fight the scourge of heroin and opioid abuse in his state, which has one of the highest overdose rates in the country.

“Pennsylvania’s opioid crisis impacts all areas of the state – including urban, suburban and rural communities and all ages including both young people and older Pennsylvanians – and is unprejudiced in its reach and devastation,” the declaration says. Virginia and other states have issued similar declarations.

Gov. Wolf’s effort comes months after President Trump declared the opioid crisis a national public health emergency and the president’s opioid commission released its final report, recommending more federal funding for addiction treatment, further restrictions on opioid prescribing, and the development of new non-opioid painkillers.

However, the commission’s report spent little time discussing an issue that is key to confronting the problems of opioid addiction and overdose – opioid tolerance.  “Tolerance” is defined as a decrease in effect following repeated or prolonged use of a drug, which can result in the need for higher and higher doses to achieve the same result.  For patients suffering from acute or chronic pain, this means that they need more pills to alleviate their pain. 

Tolerance can lead to a dangerous cascade of consequences. According to researchers at the National Institutes of Health, “the repeated administration of any opioid  almost inevitably results in the development of tolerance and physical dependence.” 

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Although not all who become opioid tolerant become addicted, the World Health Organization asserts that people dependent on opioids are the group most likely to suffer an overdose. Given the seriousness of the problem, researchers have been looking for a way to prevent opioid tolerance and keep opioid users in a state of analgesia.  In that quest, some have found an answer in stem cells. 

In a recent study, Dr. Jianguo Cheng and scientists at the Cleveland Clinic and the Affiliated Hospital of Qingdao University in China hypothesized that mesenchymal stem cells (MSCs) could prevent or reverse opioid tolerance and opioid-induced hyperalgesia because of their profound anti-inflammatory properties. 

To prove their hypothesis, they induced opioid tolerance in laboratory mice and rats by injecting them with morphine for four weeks.  Astoundingly, after administering MSC therapy to the opioid-tolerant rodents, tolerance was reversed within as little as 2 days. The injections appeared to be completely safe.  All of the rodents showed normal movement, food and fluid intake, and body weight gain.  Their livers, kidneys and other major organs continued to function normally.

The authors concluded that MSCs have “enormous potential to profoundly impact clinical practice and improve opioid efficacy and safety.”  Their study builds on previous research that found MSC therapy “does not produce unwanted side effects and is well tolerated and safe.”  Rejection of the stem cells was not an issue because MSCs are immune-privileged.

America’s opioid problem is as destructive as ever.  If the states and the president’s commission truly seek novel, innovative and readily-implementable solutions to the opioid crisis, tolerance is a critical target and stem cell therapy may be a viable solution.  Patients in pain need solutions now.

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A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Stem Cells: Signs of Progress in a Rigged Game

By A. Rahman Ford, Columnist

The Wall Street Journal recently published an article on the use of stem cell therapies for knee problems, including arthritis.  Overall, the perspective of the piece was positive and it has several laudable aspects.  Physicians from large academic institutions, such as Harvard University and Stanford University, were interviewed to provide their opinions on the use of autologous stem cells derived from a patient’s own fat or bone marrow for certain painful orthopedic indications. 

The article rightly acknowledges the high patient demand for these autologous therapies. It also mentions how the U.S. lags behind other countries in offering them and the disturbing fact that this therapy is not covered by medical insurance.  The doctors who were interviewed also discussed how conventional approaches to osteoarthritis in knees – meniscus surgery, microfracture surgery, etc. – often fail to demonstrate long-term benefit.  These doctors, along with many others around the world, recognize that we need new therapies for orthopedic conditions.

Any positive portrayal of the clinical uses of stem cells should be welcomed. The unfortunate truth is that many potential patients are scared off by publications that focus their reporting on the alleged malfeasance of a few bad-actor stem cell clinics.  These same publications often neglect to cover the countless stem cell success stories from clinics in the U.S. and abroad. 

A focus on these promising results may help allay those fears and convince some of those fearful patients that stem cells are, in fact, a viable medical option for their chronic orthopedic pain. 

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Less fear can lead to self-education and increased awareness of the safety and potential of stem cells.  Patients may even try stem cell therapy and become advocates.  In this sense, the WSJ piece is good public relations for stem cell therapies overall.

However, there is an unsettling undertone in the WSJ piece and media coverage in general of stem cells, which places too much emphasis on the opinions of clinicians from certain large institutions.  That diminishes the value of work being done in smaller stem cell clinics, which have been safely and effectively treating patients with orthopedic conditions for years. 

The unintended implication is that Harvard and Stanford physicians’ assessments are more legitimate because of the perceived prestige of their employers, and because they follow the guidelines that the FDA set forth for pursuing such treatments.  Of course, these institutions have millions of dollars in capital that it takes to conduct clinical studies and comply with these guidelines, while smaller clinics often do not.  We must take care to avoid creating or reinforcing illegitimate hierarchies that give some physicians more scientific authority than others, based solely on money, perceived prestige, or the ability to adhere to an unfair set of rules.

The sad truth is that the stem cell game is rigged.  The FDA’s rules regarding the use of autologous stem cell therapies favor those with more financial resources because they can afford expensive clinical trials.  Medical innovation cannot be strictly the domain of wealthy institutions with the finances to play on a tilted field.  The FDA’s “minimal manipulation” and “homologous use” regulatory standards for using stem cells are unduly burdensome and need to be relaxed for autologous stem cell uses. 

Recently, the FDA issued a warning letter to American Cryostem, a company involved in the manufacture of adipose stem cell products derived from a patient’s body fat.  In addition to manufacturing violations, the company was accused of violating the FDA’s “minimal manipulation” and “homologous use” standards. 

Setting the merits of the case aside, it is emblematic of the FDA’s crackdown on clinics that are much smaller than Harvard and Stanford, but which have been relieving patients’ pain with autologous therapies for years.  Their scientific contributions must not be subordinated or dismissed as illegitimate or inconsequential.

Stories of how stem cells are entering mainstream medicine can help us realize the goal of available, affordable stem cell therapy for all Americans.  However, valorization of those institutions with the means to “play within the rules” must not come at the expense of sounding the alarm that the rules themselves are patently unfair.

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A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Warns New Jersey Stem Cell Company

By Pat Anson, Editor

The U.S. Food and Drug Administration has warned a New Jersey biotechnology company to stop producing and marketing a stem cell product, the latest in a series of steps the agency has taken to rein in the fast growing stem cell industry.

The FDA sent a warning letter to American CryoStem Corporation for marketing adipose derived stem cells without FDA approval and for “significant deviations” from manufacturing guidelines.

American CryoStem is using adipose tissue – a patient’s own body fat – to create a product called Atcell, which is promoted as a treatment for stroke, brain injuries, Parkinson’s disease, amyotrophic lateral sclerosis (ALS) and multiple sclerosis.

The FDA said there was “more than minimal manipulation” of adipose tissue in the manufacturing of Atcell, which introduced the potential for contamination. The agency said Atcell should undergo clinical trials and an FDA review to prove its safety and effectiveness before being marketed.

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“The use of Atcell raises potential significant safety concerns, due in part to the fact that there is little basis on which to predict how the product will perform in a patient,” said Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research. “In addition, this product may also cause harm to patients who may put their trust in an unproven therapy and make the decision to delay or discontinue medical treatments proven to be safe and effective.”

The FDA issued new guidelines for stem cell therapy last November, a “risk-based approach” that critics say could slow the development of novel treatments for autoimmune diseases, cancer, diabetes, neuropathy, back pain and other illnesses.  

As PNN has reported, hundreds of stem cell clinics have opened around the country, often mixing hope with hype by making claims such as, “You don’t have to accept chronic pain as a fact of life.”  The treatments are expensive and usually not covered by insurance. 

Some patients receiving stem cell therapy have reported remarkable recoveries from chronic conditions once deemed untreatable.  Sara Bomar, for example, was confined to a wheelchair after being diagnosed with arachnoiditis, a painful inflammation of nerves in her spinal column. She started walking again after a high dose infusion of stem cells made from her adipose tissue.

The warning letter to American CryoStem was sent nearly six months after FDA investigators inspected the company’s laboratory in Monmouth Junction, New Jersey, finding “significant safety concerns” and “objectionable conditions.”  The firm has implemented changes at its lab to respond to the FDA’s concerns, however the agency said the response “inadequately addresses" the problems and failed to recognize that Atcell is an unlicensed product.  The FDA gave the company 15 working days to respond to its warning letter.

American CryoStem did not respond to PNN’s request for comment.  The company bills itself as a “biotechnology pioneer” in the use of adipose stem cells, and has laboratories in Hong Kong, mainland China and Japan. It recently licensed the patent rights to its stem cell technology in China and plans to expand its operations there.

The FDA Got it Wrong on Stem Cells

By A. Rahman Ford, Columnist

In August, FDA Commissioner Scott Gottlieb, MD, signaled that his agency would move in the direction of enhanced regulation of stem cell therapies.  He said the action was justified because of “unscrupulous actors” who deceive patients with what he described as “dangerously dubious products.” 

Although the FDA referred to its prospective actions benignly as “enforcement” and “protection,” the likely impact seemed obvious – safe and effective therapies that have been healing patients for years would become less available and more expensive. 

Those concerns have now been made real.

This week the FDA released its final guidance on regenerative medicine and stem cell therapy, an approach that relies extensively on more regulation.

“We’re at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease,” Gottlieb said in a statement.

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“We’re adopting a risk-based and science-based approach that builds upon existing regulations to support innovative product development while clarifying the FDA’s authorities and enforcement priorities. This will protect patients from products that pose potential significant risks, while accelerating access to safe and effective new therapies.”

Unfortunately, from both a patient and policy perspective, the FDA’s guidance is distinctly retrograde, drifting backward against a cosmic tide of scientific discovery that should be propelling post-modern medicine forward.  Not only are the FDA’s actions potentially detrimental to the health of Americans who suffer from chronic illnesses that could be treated or even cured by stem cells, they could cripple the entrepreneurship, ingenuity and cost-effectiveness of regenerative medicine. 

For the next 36 months, Gottlieb says FDA will adopt a “risk-based approach” in enforcement of the new rules, “taking into account how products are being administered as well as the diseases and conditions for which they are being used.”  While this grace period seems reasonable, the final guidance makes clear that the FDA will prioritize the oversight of clinics that deliver stem cells via intravenous infusion, in part because “use of these unapproved products may cause users to delay or discontinue medical treatments that have been found safe and effective.”

But intravenous stem cell administration has been safely used to treat patients suffering from painful autoimmune diseases like multiple sclerosis.  I have personally had intravenous stem cell therapy, and found it to be both safe and effective. 

‘Minimal Manipulation’ Test Tough to Pass

While well intended, the FDA’s guidance suffers from unduly restrictive definitions of “minimally manipulated” and “homologous use” -- key standards that will determine the availability of future stem cell therapies. 

Stated simply, stem cells that are “minimally manipulated” will not need to be approved by the FDA via clinical trial.  But that’s a tough test to pass and would seem to rule out mesenchymal stem cells, which help reduce inflammation in orthopedic and autoimmune conditions, conditions that cause unbearable pain for countless Americans.  The FDA’s conception of “minimally manipulated” is simply too limited.

The “homologous use” definition is likewise flawed.  Even if a stem cell product passes the “minimally manipulated” test, the cells used must “perform one or more of the same basic functions in the recipient as the cells or tissues performed in the donor.”  Under this definition, blood stem cells can be transplanted into a person with a disorder affecting their blood system, but cannot be used to repair damaged tissue, as in the case of a child’s cerebral palsy or a wounded veteran’s traumatic brain injury.

However, in a cruel twist, adipose (fatty) tissue used for cosmetic procedures like breast reconstruction and augmentation do satisfy the “homologous use” test and do not require a clinical trial.

Essentially, under these guidelines, the FDA strong-arms the child with cerebral palsy and the war veteran to the back of the medical bus, while giving breast augmentation the VIP treatment and ushering it to the front.  Sorry FDA, big breasts are not more important than curing diseases. 

FDA Should Respect Privacy Rights

Additionally, as I have written about previously, Americans have a constitutionally-protected privacy right in their own cells.  The FDA’s new rules completely ignore this right.  It is a basic right that emanates from established Supreme Court case law and fundamental principles of personal liberty and autonomy, and protections against undue intrusions upon bodily integrity. 

One’s body and one’s health are indeed intimate and personal matters that federal agencies must respect.  Instead of being overly preoccupied with a cell’s “same basic function,” the FDA needs to be concerned with a person’s “fundamental basic right” to use their own cells as they see fit.

In fact, one could easily argue that sufficient government regulation and patient protections already exist in federal and state law, as well as medical ethics boards.  The truth is that additional federal regulations are unnecessary, unduly burdensome, and infringe upon the sanctity of the physician-patient relationship and our right to control our own bodies. 

Commissioner Gottlieb’s declaration that patient safety is of paramount concern is a pleasure to hear.  However, in practice, the FDA’s regulatory efforts will likely serve to retard medical innovation and force Americans to travel abroad for life-saving stem cell therapies. They also preserve a “clinical trial” approach to treatment that, when applied to stem cells, has proven itself to be unduly burdensome, unreasonably slow, and unbelievably expensive.

Ultimately, what is abundantly clear is that the American people have spoken.  Their voices are filled with pain and they must be heard.  Retrograde stem cell policy is inimical to curing disease and is an affront to the elimination of pain. 

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A. Rahman Ford, PhD, is a freelance researcher and writer on the issues of politics, policy and health. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor in Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

4 Infusions That Can Help Relieve Chronic Pain

By Barby Ingle, Columnist

I am so excited to finally be to my favorite letter – "I" -- in my series on alternative pain treatments. The “I” stands for infusions.

There are many different types of infusions, but the four I will cover are ketamine, immunoglobulins, lidocaine and stem cells. I have done 3 of the 4, and one of my good friends has done the fourth with great success. So I feel comfortable sharing what I know about infusions based on my personal health journey.

Ketamine

I was afraid of ketamine when I first heard about it. Ketamine was created in 1962, when it was first synthesized by scientist Calvin Stevens at the Parke Davis Laboratories. Ketamine is a potent anesthetic that blocks pain by acting as a N-methyl-D-aspartate (NMDA) receptor antagonist. It can also reset glia nerve cells in the spine and brain.

Ketamine is not appropriate for everyone. For me, I saw it as a chance to reverse the Reflex Sympathetic Dystrophy (RSD) that I had been living with since 2002.  My excitement was great, along with my family’s. My regular treating doctors were not so optimistic about ketamine, but were not discouraging it either.

I began receiving ketamine infusions in 2009. They put me into remission and I continue with booster therapy as needed. I still have flares, but ketamine got me through the biggest challenges of living with RSD. Here is a video of me after my initial infusion treatments, which many find motivational.

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Before I started getting ketamine infusions, they wanted me off opioids completely so that my nervous system would reboot better. Research showed that ketamine patients on opioids were not getting the same good results as people who stopped taking them. Since then, I have also learned that opioids also set off glia cells, which is not a good thing for nerve pain patients.

Immunoglobulins

Intravenous Immunoglobulin – known as IVIg --  is used to treat various autoimmune, infectious and idiopathic diseases. One of my best friends, who has multifocal motor neuropathy, uses it to stay functional.

I have not had IVIg yet, but if ketamine didn’t work for me, I would give it a try, insurance permitting. The cost per treatment is between $5,000 and $10,000, so for many it is not an option.

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If you have the cash, the FDA has approved IVIg for graft disease and idiopathic thrombocytopenic purpura (ITP). It is also used to treat patients with Kawasaki disease, Guillain-Barre syndrome, and polymyositis/dermatomyositis. I know a number of people who have used it for RSD.

One of the complaints I have heard from friends who use IVIg is that it takes time before your feel any benefits – sometimes days or weeks. If it is a viable treatment for you, there should be some changes in your symptoms and pain levels within 4 weeks.

However, some people do not respond to IVIg and it is very expensive to try just to see what happens. The cost is high because immunoglobulin products come from the pooled human plasma of a thousand or more blood donors, who have to go through an extraction process themselves before it can be processed and ready for use in infusions.

Stem Cells

Stem cell research could pave the way for an entirely new approach to chronic pain that reduces the current reliance on opioids and other analgesics.

I tried two rounds of stem cell infusions for gastroparesis, intestinal ischemia, heart valve dysfunction, cardiac ischemia, and temporomandibular joint disorder (TMJD).

The infusions reversed my gastrointestinal issues within 24 hours and my heart issues in 7 days, but it took longer for my TMJD to feel any relief. I did get some, just not as much as the other areas of my body. I also got improved function in my ovaries, with an increase in estrogen production I did not have before stem cell therapy.

The providers I worked with said it would take 6 to 8 rounds of stem cell infusions to help my nerve pain. I don’t have the money for that, so I stopped after two treatments.

Stem cell studies I have seen show great promise for multiple sclerosis patients, and I will be watching closely to see if it works for RSD and other neuro-autoimmune diseases. Stem cells could also be used as a tool to reverse opioid tolerance and opioid-induced hyperalgesia, two problematic side effects of opioid therapy.

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Lidocaine

Although my providers told me that lidocaine infusions are practically pain free, I can tell you they are not. The lidocaine infusions I was given were in conjunction with my stem cell therapy. I felt everything and came away feeling that lidocaine was not a good option for me.

My step sister did have good results from her 7-day infusions of lidocaine, so it goes to show that you have to check to see what works best for you.

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Lidocaine is an amide anesthetic and has a wide range of mechanisms of action. Research has shown that lidocaine, when given in a low dose intravenous infusion, has successfully provided pain relief for several chronic pain conditions that have failed other treatment modalities. A recent study in Pain Medicine found that lidocaine provided pain relief to 41 percent of patients, most of whom had neuropathic pain. 

According to providers at Stanford University, the success of lidocaine infusion is dependent on the specific cause of your pain. Some patients report immediate and long lasting pain relief, while others say relief came slowly and only lasted while the medication is being infused. Some patients also report unpleasant side effects.

The only adverse reaction I had – besides the fact it didn’t work for me – is that the infusion itself was extremely painful. Physicians have no way of knowing how you’ll react until you try it. By the time I was begging for help during the infusion, it was too late.

PNN columnist Crystal Lindell has been getting lidocaine infusions and they’ve helped Crystal reduce her use of painkillers. A recent study in Pain Medicine found that lidocaine provided long-lasting pain relief in 41 percent of patients, most of whom had neuropathic pain. 

I would be glad to share more of my experiences with infusions for anyone who has questions from the patient perspective. I would also love to hear your stories about infusions and whether they worked for you. 

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Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain FoundationShe is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

A Promising Solution to Lower Back Pain

By A. Rahman Ford, Columnist

As many of us can attest to, lower back pain (LBP) is a debilitating and painful medical condition that severely impacts quality of life.  An analysis of the Global Burden of Disease in 2010 showed that LBP ranked as the greatest contributor to disability out of nearly 300 conditions studied. 

Lower back pain tends to peak in older age groups; thus, regions with higher life expectancies are disproportionately impacted.  The number of people with LBP is projected to increase in the coming decades, especially in low- and middle-income countries.  About 149 million work days are lost every year in the U.S. because of LBP, at an estimated cost of $100-200 billion.  

Of course, the costs to the patient – both financial and emotional – can never be adequately quantified.

Tough Questions, Few Answers

Although the causes of LBP generally are multifarious, the National Institutes of Health maintains that the majority of cases are mechanical in nature.   The gradual degeneration of the spine as a result of normal wear and tear – referred to as spondylosis – can result in a myriad of painful conditions that range from simple sprains, to herniated or ruptured discs, to injuries caused by trauma. 

While the causes of lower back pain are rarely addressed, analgesic medications are routinely prescribed to treat its symptoms.  Commonly prescribed medications include opioids, NSAIDS, anticonvulsants, antidepressants, counter-irritants and epidural steroid injections.

However, these analgesic treatments have shortcomings: potentially dangerous side-effects, adverse drug interactions, addiction, organ damage or only temporary relief.  Other treatment options include physical therapy, transcutaneous electrical nerve stimulation (TENS), acupuncture and in extreme cases, surgery. 

Sadly, neither the conservative management nor the more invasive surgical options consistently yield satisfactory results, because they fail to address the underlying disease processes.  In fact, some treatments may actually lead to a worsening of the condition in the long term.  Undoubtedly, new approaches are needed to solve the problem.

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Research Supports Stem Cells for LBP

Many cases of lower back pain involve structural damage to the intervertebral discs, either by way of a herniated disc or degenerative disc disease (DDD).  This condition is quite prevalent among older adults, with one study finding that 95% of older Americans exhibiting some degree of disc degeneration. 

In the search for treatments beyond analgesics and surgery, several researchers have demonstrated the effectiveness of stem cell therapy in treating disc injuries in both humans and animals. 

Leung et al. (2006) and Drazin et al. (2012) noted the potential for mesenchymal stem cells (MSC) to treat intravertebral disc degeneration in laboratory animals.  Orozco et al. (2011) used autologous bone marrow-derived MSCs to treat 10 patients with lumbar disc degeneration, who exhibited rapid improvement in pain and disability. 

Similarly, Pettine et al. (2015) reported significantly reduced pain scores in 26 patients who received autologous bone marrow-derived stem cells. 

Coming to a Clinic Near You?

Just this year, Centeno et al. successfully used an injection of autologous bone marrow derived MSCs to treat DDD in 33 patients with lower back pain.  The authors found “no safety issues, substantially reduced pain, increased function and reduced disc bulge size in most patients.”

That treatment utilized stem cell technology created by BioRestorative Therapies, which uses autologous bone marrow-derived MSCs to treat chronic lumbar disc disease.  According to the company’s website, “not only could this program potentially eliminate surgery in many cases, but it could also provide substantially more effective treatment than current non-invasive therapies with a design to be curative.”  The company has been cleared by the FDA for Phase 2 clinical trials to treat lower back pain due to DDD.

DiscGenics, a biotech company based in Utah, has also received FDA approval for a study of stem cell therapy to treat patients with intervertebral disc disease. DiscGenics’ approach is different, because it uses patented technology to derive its proprietary “discogenic cells” directly from adult human disc tissue.

“We believe it has the potential to offer pain relief and restored function to millions of patients suffering from the debilitating effects of lower back pain,” DiscGenics CEO Flagg Flanagan told The Salt Lake Tribune. “Receiving the go-ahead from the agency to begin in-human trials is a critical step forward for our clinical program.”

DiscGenics plans to begin enrolling 60 patients in the study before the end of the year.  

Although both BioRestorative and DiscGenics have therapies that look promising, it will be some time – likely years – before either treatment is publicly available. But these studies could be a major step forward in finding an actual cure for back pain, not just another treatment that masks the pain.

A. Rahman Ford.jpg

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor in Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

How the FDA Can Help Solve the Overdose Crisis

By A. Rahman Ford, Columnist

As the U.S. Food and Drug Administration prepares to issue new guidelines on stem cell therapy, it must give due consideration to the ever-increasing number of Americans who suffer from intolerable chronic pain.

According to the National Institutes of Health, over 25 million American adults suffer from chronic pain and nearly 40 million have severe levels of pain.  To alleviate that pain, many turn to addictive opioid medications, sometimes with deadly consequences. 

Under former FDA Commissioner Robert Califf, the agency took several steps to reduce opioid addiction, including improved warning labels, enhanced education for prescribers, and the development of abuse-deterrent drug formulations. 

Unfortunately, those initiatives have had negligible success in stemming the tide of opioid overdose, perhaps because, as Califf himself put it, “financial incentives in the (pharmaceutical) industry can lead to a focus on short-term profits instead of patient well-being.”

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Indeed, although opioid addiction has seeped into the public consciousness and ascended to the top of many politicians’ agendas, the attention has been largely rhetorical -- practical, immediate-term solutions to the overdose crisis remain few and far between.  Clearly, new approaches are needed. 

Stem cell therapy can be a meaningful intervention in the effort to eradicate chronic pain and end opioid deaths.  The fact is that many physicians are already using stem cells to treat chronic pain safely and effectively, and have been doing so for years. 

Stem cell therapy can be a meaningful intervention in the effort to eradicate chronic pain and end opioid deaths.  The fact is that many physicians are already using stem cells to treat chronic pain safely and effectively, and have been doing so for years.  But with the issuance of new guidelines, which are expected this fall, the FDA could very well limit access to stem cell therapy, even to stem cells that come from our own bodies. 

Current FDA Commissioner Scott Gottlieb recently said stem cells hold “significant promise for transformative and potentially curative treatments,” but some unscrupulous stem cell clinics were preying on sick people desperate to find cures. While cracking down on these bad actors, Gottlieb must not lose sight of the fact that stem cell therapy is a potential solution to everyday Americans’ chronic pain.

Science Supports Stem Cells for Pain

Let’s take a brief look at some of the recent scientific literature about stem cell therapy, and how it can attenuate or even eliminate the chronic pain that results from a myriad of medical conditions. 

A 2014 study in the Journal of Pain Research made the case for the use of adult stem cells to treat neuropathic pain.  Due to the "scarce response to the conventional analgesic therapy,” the authors said it was “mandatory to identify and propose novel approaches" to neuropathic pain. They noted the “fast onset and long-lasting effect on pain relief that one injection (of stem cells) could provide,” an outcome far superior to drugs which require chronic administration, have side effects, and require periodic dose increases.

That same year, an editorial in the British Journal of Medical Practitioners entitled “Stem Cell Therapy: The Future of Pain Medicine” claimed that “recent advancements for SCT (stem cell therapy) for pain due to degenerative diseases in the spine and joints are promising and indicative that SCT will undoubtedly play a major role in the future.” 

A 2015 review in the World Journal of Stem Cells examined the plausibility of using stem cells to treat acute, chronic and neuropathic musculoskeletal pain, concluding that stem cells “show promise for several chronic non-life-threatening yet disabling conditions.”

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Just this year, in a review published in Frontiers in Immunology, researchers said stem cells derived from a patient’s bone marrow “may provide efficient, long-term, and safe therapy for patients with painful diseases” such as osteoarthritis, degenerative disc injuries, inflammatory bowel disease, neuropathic pain, and pain associated with cancer and radiotherapy.

Stem cells can alleviate pain in a myriad of ways.  A recent study published in Military Medicine found that a low-dose stem cell injection significantly attenuated neuropathic pain in injured rats, regardless of whether the cells were derived from bone marrow or adipose (fatty) tissue.  The authors concluded that the therapy “has great potential to emerge as an innovative, safe, efficacious, and cost-effective therapy for the treatment [of] neuropathic pain or other chronic pain conditions.”

A 2016 study published in International Orthopaedics followed 26 patients who suffered from chronic discogenic lower back pain who were injected with their own bone marrow concentrate.  All 26 patients had a significant decline in their pain and disability scores, and were able to avoid surgery. 

Stem Cells Can be a Remarkable Solution

As the above sampling of literature suggests, stem cells can treat chronic pain caused by several illnesses.  It is important to note that no subjects in any of the referenced studies experienced significant adverse effects.  Safety was simply not an issue.  The results regarding the use of autologous stem cells – a patient’s own stem cells -- are especially noteworthy because, so long as the cells are “minimally manipulated,” under current FDA regulations approval is not required.

If this were to change due or be restricted under new FDA guidelines, many patients would be left with no viable pain treatment options.  Let us not forget that former Texas governor and current Secretary of Energy Rick Perry once suffered from chronic back pain, and found no answer in surgery or pills.  Perry found relief in his own stem cells.  All of us deserve that chance.

On June 13 of this year, Commissioner Gottlieb made it clear that “everyone at the FDA is committed to focusing on all aspects of the [opioid] epidemic” and promised to seek input from the public “to share additional steps and information that the FDA should consider in addressing these challenges.” 

Commissioner Gottlieb, a growing number of Americans like Secretary Perry are already using stem cells to solve problems that current treatment modalities have failed to cure.  They're traveling to clinics at home and abroad because their pain is disabling and insufferable. 

Commissioner Gottlieb, by adopting a forward-thinking policy on stem cell therapy – specifically autologous stem cell therapy – you can fulfill your promise to the American people.

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A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor in Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

NFL Players Tackle Pain with Regenerative Medicine

By A. Rahman Ford, Columnist

Several members of the Seattle Seahawks have opted for a regenerative medicine therapy called Regenokine to treat their pain and injuries, and the players believe it has made a big difference. 

The Seahawks were one of the NFL’s healthiest teams last season, ranking 5th out of 32 teams overall.  However, key players such as defensive back Earl Thomas and wide receiver Tyler Lockett had season ending injuries. Other players, like quarterback Russell Wilson and cornerback Richard Sherman, had nagging injuries that limited their effectiveness on the field. 

Unfortunately, serious injuries are all too common in the NFL.  According to NFL injury data, the incidence of anterior cruciate ligament (ACL) tears in the knee during the regular season has remained relatively consistent since 2012, with 36 reported in 2016. 

Likewise, the incidence of medial collateral ligament (MCL) tears has remained steady, with 143 incidents reported last season.  Suffice it to say, these injuries can require surgery, shorten playing careers and can be extremely painful, both physically and emotionally.

 SEAHAWKS RECEIVER DOUG BALDWIN

SEAHAWKS RECEIVER DOUG BALDWIN

Painkiller Use in the NFL

To cope with the pain, many NFL players resort to using opioid painkillers. According to the Washington Post, sealed court filings in a lawsuit filed by 1,800 former players asserted that the NFL violated federal law in prescribing painkillers to players.  Specifically, the players contended that the NFL disregarded DEA guidance on how to distribute controlled substances, and encouraged players to use powerful painkillers and anti-inflammatory drugs.  Team doctors who were deposed admitted to violating federal laws in prescribing painkillers. 

According to the filings, the average NFL team prescribed 5,777 doses of NSAIDs and 2,213 doses of controlled medications.  This amount averages to about 6-7 pain pills or injections per week per player. As a result, the players maintain that they suffered long-term organ and joint damage. 

In some cases, painkiller use in the NFL has led to addiction.  Hall of Fame quarterback Brett Farve, known for his durability and aggressive play, detailed how he would take 15 Vicodin at a time every day, and even resorted to asking teammates for their pills.

Regenerative Medicine as an Alternative to Existing Pain Therapies

In search of treatment options, several Seahawks traveled to England this year for a procedure known as Regenokine, or Orthokine.  The patented process was invented by Dr. Peter Wehling, Co-Director of the Center for Molecular Orthopaedics and Regenerative Medicine in Dusseldorf, Germany.  He, along with Klaus Wehling and biologist Dr. Julio Reinecke, founded the company Orthogen in 1993 to provide a joint-preserving alternative to traditional surgery. 

Orthokine works by using a patented syringe to incubate the “autologous conditioned serum” (ACS) in a patient's blood. In this phase, the blood is exposed to glass spheres, enriching the number of anti-inflammatory cytokines, interleukin agonists, and multiple growth factors.  After incubation, the blood is spun in a centrifuge to separate the solid components from the serum.  The ACS is later injected into the affected tissues. 

The therapy is not yet FDA approved, but is being offered by some clinics in the U.S. The cost of the procedure can vary.  Lloyd Sederer, MD, chief medical officer of the New York State Office of Mental Health, went to California in 2011 for ACS therapy of his arthritic knees and sore shoulders. He was charged $9,000 for the first joint and $3,000 for each subsequent joint.

Is the Treatment Effective?

Research on the effectiveness of the ACS/Orthokine/Regenokine treatment is scant but positive.  A 2015 study by Garcia-Escudero and Hernandez-Trilllos of 118 patients with unilateral knee osteoarthritis found significant improvements in pain over a two-year period.  These patients chose to forego surgery and instead opted for ACS and physiotherapy. 

A 2009 study had similar results with 376 osteoarthritis patients, concluding that the ACS therapy reduced pain and increased functional mobility for up to two years.  However, Rutgers et al. (2015) found no significant, long-term clinical improvement in 20 patients with osteoarthritis treated with ACS.  In 2009, Becker et al. used ACS successfully on patients with unilateral lumbar radiculopathy, or sciatica.  Ravi Kumar et al. (2015) replicated those results in 20 patients, leading the authors to conclude that “ACS can modify disease course in addition to reducing pain, disability and improving general health.”  In no study were there significant safety issues.

The reality is that interest in the therapy is largely driven by anecdotal, but promising evidence.  Dr. Sederer, who detailed his ACS treatment in an Atlantic article, was very happy with the results.  Seahawks linebacker K.J. Wright had ACS therapy to treat his nagging knee injury and told the Seattle Times he felt “1,000 percent better” than before.  Receiver Doug Baldwin, Defensive End Michael Bennett and several other Seahawks also traveled to Europe for ACS therapy.

Player reports have been so positive that Seahawks head coach Pete Carroll affectionately refers to receiving the therapy as “entering the circle.”  Other athletes have reported similar positive results, including MLB player Alex Rodriguez, NBA star Kobe Bryant and professional volleyball player Lindsay Berg.

Another Option in Tackling Chronic Pain

Overall, ACS/Orthokine/Regenokine therapy is very promising in treating pain.  However, the dearth of clinical data may cause some patients to choose a different option.  In addition, the cost – which is not covered by insurance – is likely prohibitive for most. 

To further complicate matters, there have been no published studies comparing the efficacy of ACS to other, better researched regenerative therapies such as platelet-rich plasma (PRP) therapy or stem cell therapy.  However, the good news for patients is that regenerative medicine alternatives to prescription painkillers are becoming more popular and more widely accepted.

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A. Rahman Ford, PhD, is a lawyer and research professional who lives with chronic inflammation in his digestive tract. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor in Chief of the Howard Law Journal.

Rahman has received stem cell treatment and closely follows developments in regenerative medicine. He is not affiliated with any stem cell treatment provider.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Should Tread Carefully with Stem Cell Regulation

(Editor’s note: This week FDA commissioner Scott Gottlieb said the agency would crack down on clinics that offer experimental stem cell treatments. While acknowledging that stem cells offer “significant promise” for treating chronic pain and other chronic conditions, Gottlieb said some clinics were preying on sick people desperate to find cures.

A. Rahman Ford has received stem cell treatment and has been closely following developments in stem cell research and regenerative medicine.)

By A. Rahman Ford, Columnist

On its face, FDA Commissioner Gottlieb's statement seems like a reasonable approach to regulating stem cell therapies.  He emphasizes the need to balance costs and benefits, and the need to protect vulnerable consumers from exploitation. 

I think all can agree with the Commissioner when he states that "these technologies hold the potential to significantly alter the course of a broad range of diseases."  These diseases are often accompanied by intense physical pain that pharmaceuticals cannot relieve.

Specifically, the Commissioner makes three heartening observations. First, he acknowledges the "significant promise for transformative and potentially curative treatments" offered by regenerative medicine.  This is a promise that mainstream pharmaceutical medicine has yet to fulfill, and one that those suffering from chronic pain need addressed immediately. 

Second, it is without question that regulatory clarity and the resolution of legal uncertainty regarding these therapies' use can be a good thing.  If there are in fact an irresponsible "select few," or a minority of unscrupulous, exploitative "bad actors" as the Commissioner claims, then legal action by the FDA against them is reasonable. 

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fda commissioner scott gottlieb

Finally, the Commissioner seems to implicitly recognize how critical it is for the FDA to respect the distinction between medical products subject to agency oversight, and those which fall under the "practice of medicine," a distinction which Commissioner Gottlieb acknowledges is fraught with "close calls."

That said, as an advocate for patients seeking stem cell therapies, upon reading Commissioner Gottlieb's statement I am overall circumspect.  It is well known that the FDA has a rather unsettling history of issuing regulations that unduly restrict patients' access to stem cell therapies, specifically autologous stem cell therapies.  These are therapies that use cells harvested from one person, are minimally manipulated, and then administered to the same person. 

I've previously made my position on this "personal" stem cell therapy known, particularly the privacy implications involved. 

Restrictions such as the unduly burdensome "minimally manipulated" federal standard and the "same basic function" requirement are clear evidence of an intent to restrict.  So, the fact that Commissioner Gottlieb's statement reiterates the "same basic function" standard as a factor in requiring that a stem cell therapy be approved through a clinical trial, rather than it being part of the "practice of medicine," seems to indicate more of the same federal overreach.

Make no mistake, the potential dangers of stem cell therapy are real, and proactive effort to protect patients is far better than any reactive effort.  However, the potential dangers should not be overstated or exaggerated ostensibly toward the end of more unnecessary restrictive regulation. 

The FDA has a history of doing this.  For example, the New England Journal of Medicine published a commentary in March by then FDA Commissioner Robert Califf arguing that, aside from a few indications, the clinical use of autologous stem cell therapies has not been proven effective and can even be dangerous. 

Not only did the article ignore years of clinical data from medical practitioners, the one cited example of the danger of autologous stem cells was actually an example of allogeneic stem cell use -- stem cells from another person!

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Thus, when the Commissioner asserts that the FDA will "aid in the effort to bring novel therapies to patients as quickly, and as safely, as possible," it simply belies history.  Likewise, overtures made toward any potential regulations being congruent with the 21st Century Cures Act are dubious.  The spirit of the Cures Act is clear; it calls for the "accelerated approval for advanced regenerative therapies." 

More federal regulation rarely, if ever, leads to acceleration of anything.  In fact, it almost always tends to slow things down.  Thus, unnecessary and unreasonably burdensome regulation by the FDA could contravene the will of Congress, and thus the will of the American people.

Texas Legalizes 'Personal' Stem Cell Therapy

Furthermore, the FDA's prospective regulatory guidance must be viewed in the context of recent events in Texas.  On June 13, Texas governor Greg Abbot signed HB 810 into law, which made Texas the first state to legitimize the use of personal stem cell therapies statutorily. The signing of the bill was celebrated not only by stem cell advocates, but by the countless Americans who suffer from chronic, debilitating conditions for which the current medical services delivery model can offer only surgery and medication.  For many, it was a monumental step forward toward fulfilling the promise of regenerative medicine and realization of true health care.  

However, the FDA may have seen this move as reinforcing a "wild west" stem cell landscape, a landscape which it believes it must police.

All of us, including FDA officials, should be reminded that on February 28, at President Trump's first State of the Union speech (and on Rare Disease Day), the President took note of Sarah Hughes, a young attendee who had used her own stem cells to successfully treat Pompe’s Disease. The therapy normalized her immune system, alleviated her symptoms and helped reduce her medications from 22 to 8.

We must also remember the promise President Trump made to America's military veterans, many of whom suffer from painful, debilitating conditions that may be treated or cured by stem cells.  President Trump cares deeply about veterans' health.  He recently signed the Veterans Appeals Improvement and Modernization Act, which streamlines the process of veterans appealing claims over disability benefits.  He also signed a bill that will let more veterans bypass the Department of Veterans Affairs and instead receive treatment from private doctors. 

Finally, he signed legislation approving new tools to expand the VA's existing Telehealth Services, so veterans can schedule appointments and have video consultations from their mobile phones.  It seems obvious that President Trump would never support restricting veterans' access to the medical care they need, including stem cells.

I believe that President Trump, through his devotion to our veterans, the Congress through the Cures Act, and the American people through their need for medical alternatives, would strongly disagree with any unreasonable curtailment of stem cell therapies. 

The FDA must not defer to the opinion of "industry," and must prioritize the needs of Americans like Sarah Hughes and our suffering wounded warriors.  People are in pain and pills can’t always help them.

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A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor in Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Dr. Ford is not affiliated with any stem cell treatment provider. He suffers from chronic inflammation in his digestive tract and is unable to eat solid food.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Expands Crackdown on Stem Cell Clinics

By Pat Anson, Editor

The Food and Drug Administration is stepping up its campaign against experimental stem cell therapies, which are increasingly being used to treat cancer, diabetes, neuropathy, back pain and other chronic illnesses.

On Friday, the FDA raided two stem cell clinics operated by California Stem Cell Treatment Centers, and seized five vials of a smallpox vaccine supplied by StemImmune in San Diego. The vaccine is mixed with stem cells derived from a patient’s body fat – known as adipose tissue -- and then injected back into the patient. The FDA considers that “an unapproved and potentially dangerous treatment” for cancer.

On Monday, the FDA also sent a warning letter to a stem cell clinic in Florida, which advertises stem cells derived from body fat to treat a variety of chronic illnesses, including rheumatoid arthritis, lupus and other autoimmune diseases. Three elderly women at the clinic went blind after having stem cells injected into their eyes in an attempt to treat macular degeneration.

in a lengthy statement announcing the crackdown,  FDA commissioner Scott Gottlieb, MD, said stem cell therapy and regenerative medicine hold “significant promise for transformative and potentially curative treatments,” but some “bad actors” were preying on sick people desperate to find cures.

“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products,” Gottlieb warned.

“In such an environment a select few, often motivated by greed without regard to responsible patient care, are able to promote unproven, clearly illegal, and often expensive treatments that offer little hope, and, even worse, may pose significant risks to the health and safety of vulnerable patients.”

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Dr. Mark Berman, a co-founder of California Stem Cell Treatment Centers, told the Los Angeles Times that Gottlieb’s comments were "disparaging and misrepresentative," and showed "a lack of understanding" of stem cell treatments. 

As PNN has reported, hundreds of stem cell clinics have opened around the country in recent years, often mixing hope with hype to make claims such as “You don’t have to accept chronic pain as a fact of life.”  The treatments are expensive and usually not covered by insurance.  A clinic in Sacramento, for example, charges $5,000 for a single joint injection and $6,000 for a spinal injection.

FDA officials say there is not enough evidence to support some of the newer stem cell therapies – particularly when cells are harvested from a patient’s own body fat (adipose tissue).

“Stem cells derived from sources such as adipose tissue are being used to treat multiple orthopedic, neurologic, and other diseases. Often, these cells are being used in practice on the basis of minimal clinical evidence of safety or efficacy,” wrote Robert Califf, MD, Gottlieb’s predecessor as FDA commissioner, in a commentary published in the New England Journal of Medicine.

Some patients, however, have reported remarkable recoveries from chronic conditions often deemed untreatable. Sara Bomar, for example, was confined to a wheelchair after being diagnosed with arachnoiditis, a painful inflammation of nerves in her spinal column. She started walking again after a high dose infusion of stem cells made from adipose tissue.

“I am able to walk. I am able to workout at the Y. I am still careful. It’s not like I don’t ever have any pain, I do have a little bit from time to time. But it is nothing compared to what I had before,” Bomar told PNN.

Gottlieb said the FDA would release new guidelines in the fall to outline what types of stem cell therapy and regenerative medicine would be allowed. And he warned that more enforcement actions were coming, like the ones in Florida and California.

“I will not allow these activities to go unchecked. I’ve directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health,” Gottlieb said.

Some patients who have the resources are heading to Europe to get regenerative treatments that can't get in the U.S.  The Seattle Seahawks this week sent five more players to Germany to have their blood processed and re-injected to treat nagging injuries. The procedure involves withdrawing blood from the patient and then spinning it to produce a high concentration of platelet cells. The plasma is then injected back into the patient at the injury site, speeding up the healing process. Two other Seahawks have already had the procedure, along with athletes such as Kobe Bryant and Alex Rodriguez.

Stem Cell Vaccine Could Reverse Arthritis

By Pat Anson, Editor

A team of researchers has successfully used gene-editing technology to “rewire” mouse stem cells to fight inflammation – a finding that could pave the way for a new class of biologic drug that replaces cartilage and protect joints from damage caused by arthritis.

The stem cells, known as “smart” cells (stem cells modified for autonomous regenerative therapy), were developed at Washington University School of Medicine and Shriners Hospitals for Children in St. Louis, in collaboration with investigators at Duke University and Cytex Therapeutics in North Carolina.

The research findings are published in the journal Stem Cell Reports.

"Our goal is to package the rewired stem cells as a vaccine for arthritis, which would deliver an anti-inflammatory drug to an arthritic joint but only when it is needed," said senior author Farshid Guilak, PhD, a professor of orthopedic surgery at Washington University School of Medicine.

Guilak and his colleagues grew mouse stem cells in a test tube and then used a gene-editing tool called CRISPR to remove a gene that plays a key role in inflammation. That gene was replaced with a gene that releases a biologic drug that combats inflammation.

Within a few days, the modified stem cells grew into cartilage cells and produced cartilage tissue. Further experiments showed that the engineered cartilage was protected from inflammation.

"We hijacked an inflammatory pathway to create cells that produced a protective drug," explained Jonathan Brunger, PhD, the paper's first author and a postdoctoral fellow in cellular and molecular pharmacology at the University of California, San Francisco.

 IMAGE CREDIT: ELLA MARUSHCHENKO

IMAGE CREDIT: ELLA MARUSHCHENKO

Many current biologic drugs used to treat arthritis – such as Enbrel, Humira and Remicade -- attack an inflammation-promoting molecule called TNF-alpha. But the problem with these drugs is that they interfere with the immune system throughout the body and can make patients susceptible to side effects such as infections.

"We want to use our gene-editing technology as a way to deliver targeted therapy in response to localized inflammation in a joint, as opposed to current drug therapies that can interfere with the inflammatory response through the entire body," said Guilak. “If this strategy proves to be successful, the engineered cells only would block inflammation when inflammatory signals are released, such as during an arthritic flare in that joint."

Researchers have begun testing the engineered stem cells in mouse models of rheumatoid arthritis and other inflammatory diseases. If the work can be replicated in living laboratory animals and then developed into a clinical therapy, the cartilage grown from stem cells would respond to inflammation by releasing a drug that protects them from further damage.

"When these cells see TNF-alpha, they rapidly activate a therapy that reduces inflammation," Guilak explained. "We believe this strategy also may work for other systems that depend on a feedback loop. In diabetes, for example, it's possible we could make stem cells that would sense glucose and turn on insulin in response.

"The ability to build living tissues from 'smart' stem cells that precisely respond to their environment opens up exciting possibilities for investigation in regenerative medicine."

Farshid Guilak and co-author Vincent Willard have a financial interest in Cytex Therapeutics, a startup founded by some of the investigators. They may license the technology and realize financial gain if it is eventually is approved for clinical use.

Guilak and his colleagues at Cytex have also used stem cells to grow new cartilage that could someday be implanted into arthritic hips, delaying or eliminating the need for hip replacement surgery.

Stem cells are found throughout the body and are increasingly being used to develop new treatments to repair damaged tissue and reduce inflammation. The Food and Drug Administration considers most stem cell treatments experimental because their safety and efficacy haven’t been proven through clinical studies.