Judge Rules FDA Can Regulate Stem Cells

By Pat Anson, PNN Editor

A federal judge has ruled that the U.S. Food and Drug Administration does have the legal authority to regulate stem cells made from adipose tissue – a patient’s own fat cells.

The decision is a blow to U.S. Stem Cells, a Florida-based company that produces and markets stem cells derived from body to treat rheumatoid arthritis, lupus and other chronic illnesses. At least three of its patients were blinded after having the stem cells injected into their eyes while being treated for macular degeneration.

The FDA has been struggling in recent years to rein in the fast-growing stem cell industry, which often markets procedures that the agency considers unproven and potentially dangerous.

“Cell-based regenerative medicine holds significant medical opportunity, but those in this field who do not operate in compliance with the law can potentially cause serious harm to patients,” acting FDA Commissioner Ned Sharpless, MD, said in a statement.

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“The FDA has advanced a comprehensive policy framework to promote the development and approval of regenerative medicine products. But at the same time, the FDA will continue to take action — such as issuing warning letters or initiating court cases — against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by manufacturing and promoting products in ways that make them drugs under the law, but which have not been proven to be safe or effective for any use.”

The FDA sent a letter to U.S. Stem Cell nearly two years ago warning the company that its laboratory safety standards were inadequate and could lead to contamination.  A year later, the agency sought a permanent injunction against the company, which led to Monday’s court decision by U.S. District Judge Ursula Ungaro.  

“The clinic and its leadership have put patients at serious risk through their disregard of the law and prior FDA warnings. This decision today is a victory for the FDA’s work to stop these bad actors and to protect patients,” said Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research.

U.S. Stem Cell and its chief science officer Kristin Comella have yet to respond to the judge’s ruling. In the past, they have argued the FDA doesn’t have the legal authority to regulate cells derived from a patient’s own body tissue.

The Los Angeles Times has reported that Comella’s purported PhD in “stem cell biology” was issued by an unaccredited online university in Panama. Three-year doctorate degrees can be purchased at Panama College of Cell Science for less than $9,000. The college has been vigorous in defense of its most famous graduate.

“Through Dr. Comella’s leadership, she and her team have trained and certified more than 700 physicians worldwide in adult stem cell therapy,” the college said recently in a blog post.

KRISTIN COMELLA

KRISTIN COMELLA

“So it is understandable that against this backdrop, America’s most gifted adult stem cell clinician, Kristin Comella, should be singled out for attack, criticism, and personal smearing in an effort to chill and silence her activities, if not outright ban them. A federal lawsuit was even filed against her to stop her treatment of patients and to slow the progress of adult stem cell therapy.”

In addition to the lawsuit against U.S. Stem Cell, the FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center and Cell Surgical Network Corporation from producing cellular products for stem cell clinics without FDA approval.

The agency has also issued warning letters to a number of clinics, including one recently sent to R3 Stem Cell of Scottsdale, Arizona warning that its treatments for Lyme disease, diabetes, Parkinson’s disease, stroke, kidney failure and amyotrophic lateral sclerosis (ALS) are not FDA approved.  

Have We Reached the Stem Cell Tipping Point?

By A. Rahman Ford, PNN Columnist

One morning while watching TV, I was astonished by one of the commercials that ran.  It was an ad for stem cell therapy.  That was when it dawned on me – stem cells had finally hit the mainstream.  It was no longer a procedure of myth and mystery that people saw as strange or taboo.  It was now real, obtainable and, dare I say, normal. 

The public discourse over the legitimacy of stem cell therapy (SCT) has taken a clear turn in recent years, away from fearmongering and misrepresentation, and toward medical innovation and less restrictive federal regulation. 

Stem cell therapy may have officially reached its tipping point.

The term “tipping point” was popularized by Malcolm Gladwell.  He describes it as “that one dramatic moment in an epidemic when everything can change all at once.”  For Gladwell, certain large-scale social phenomena – which he terms “epidemics” or “contagions” – take hold through small, incremental changes that tend to happen in a hurry.  

Gladwell asserts that, like medical epidemics, “tipping point” social epidemics obey three laws:

  1. Law of the Few: They are driven by a handful of people

  2. Stickiness Factor: At a certain point a message “sticks” in the memory

  3. Power of Context: Human beings are sensitive to their environment 

Three groups of people facilitate successful social epidemics:

  1. Mavens, who possess the specific information or knowledge

  2. Connectors, who bring people together and disseminate that information

  3. Salesmen, who persuade others to believe the information. 

It’s ironic that Gladwell uses examples of medical epidemics to describe a theory that could be applied to a modality with the curative power of SCT. The increasing and diverse number of patient testimonials online shows how SCT has reached its tipping point.

Roar Africa CEO Deborah Calmeyer used her own stem cells to repair a bone chip on a toe she injured falling down a flight of stairs at a Manhattan restaurant.  After two years, her pain was gone and the cartilage completely healed. 

Grandmother Andrea Coleman of Charlotte, NC used her own stem cells to heal her arthritis pain, pain which she described as “10+.”  Less than two months after the therapy, her pain was at a “2 or a 3.”  And how did she find the clinic?  Her husband did a simple online search.

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High school wrestlers like JD Peralta of small-town Clovis, California used SCT to heal a torn ACL and meniscus. 

South Florida mother Marty Kelly credits SCT with curing her non-verbal autistic son Kenneth.  At eight years old, Kenneth couldn’t talk or reread and was still in diapers. Now, after nine treatments, 17-year-old Kenneth is about to graduate high school.  How did Marty Kelley find out about SCT?  She “stumbled” across a little boy in Orlando who also benefitted from the therapy. 

Finally, Superman actor Dean Cain used SCT to heal chronic pain from a knee injury he suffered playing college football.  He even invited DailyMailTV cameras to record the procedure.  Cain also credits SCT with controlling his father’s Parkinson’s Disease. 

When Superman becomes an SCT connector and salesman, you know you’ve reached the tipping point.

Small Clinics and Large Hospitals Tip the Scales

More and more clinics are offering SCT.  This proliferation is occurring despite the restrictive FDA regulatory regime that dictates stem cells should be “minimally manipulated” and only for approved treatments. Clearly, the medical professionals are not overly concerned with FDA policing and investigation. This is similar to marijuana which, while still illegal under federal law, is legally sold in dispensaries in dozens of states without fear of a crackdown.  

This perception that the FDA has adopted a permissive, laissez-faire stance is telling and evidences another SCT tipping point.

Not only is the number of small clinics increasing, but the availability of SCT in large, mainstream hospitals is further evidence of a tipping point.  As Liz Szabo points out in Kaiser Health News, major hospitals like the Swedish Medical Center – Seattle’s largest non-profit health provider – have begun offering SCT with infomercial-like advertisements.  The Mayo Clinic, Cleveland Clinic and the University of Miami have also entered the field to provide options to patients who have exhausted mainstream remedies. 

“We have patients in our offices demanding these treatments,” said Dr. Shane Shapiro of the Mayo Clinic. “If they don’t get them from us, they will get them somewhere else.”

A serious argument can be made that the SCT tipping point has indeed been reached.  Gladwell’s theory fits the SCT movement well.  Although the SCT movement’s initial push was driven by the few, as Gladwell conceptualized, it is the stories of the many that drive it now. 

Context has also been important. The pain and suffering of countless Americans has provided the context that has forced more clinics and hospitals to provide SCT.  And progress has been quick. Just nine years ago I had to go all the way to China for my SCT.

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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. Rahman earned his PhD at the University of Pennsylvania.

Rahman lives with 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.

Stem Cells Reduce Pain from Knee Osteoarthritis

By Pat Anson, PNN Editor

A small new study has demonstrated that stem cells collected from a patient’s own bone marrow can significantly reduce pain caused by osteoarthritis of the knee.

In the first clinical trial of its kind in Canada, researchers collected mesenchymal stromal cells (MSCs) from the spines of 12 middle-aged patients with moderate to severe knee osteoarthritis. These “autologous” cells – stem cells derived from a patient’s own fat or bone tissue – were then processed and injected back into the patients’ knees at different doses.

Researchers then followed the patients for the next 12 months, using MRI imaging, biomarkers, molecular fingerprinting and the patient's own assessment of how they felt.

"Our goal was to test for safety as well as to gain a better understanding of MSC dosing, mechanisms of action and donor selection," said lead author Sowmya Viswanathan, PhD, Arthritis Program at the Krembil Research Institute, University Health Network in Toronto.

At the end of the study period, researchers said there were significant improvements in all 12 patients’ pain levels, stiffness and quality of life. The study also showed that the MSCs were safe at all the doses tested and that the higher the dose, the more effective the outcome.

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"We also obtained novel insights into a potential anti-inflammatory mechanism of action of these cells in osteoarthritic knee joints. We noted that donor heterogeneity is an important factor, and our assembled panel of genes helps us identify cells which are potent in osteoarthritis. These are important findings which we hope to translate into a larger, powered clinical trial as part of our next steps," said Viswanathan, who reported the findings in the journal Stem Cells Translational Medicine.

Over 250 million people worldwide suffer from knee osteoarthritis (OA), which causes thinning of cartilage and progressive joint damage. Nearly 40 percent of Americans over the age of 45 have some degree of knee OA.

Knee replacement and arthroscopic knee surgeries are commonly used to treat knee OA, even though many studies show they have limited effectiveness. A 2017 study in The British Medical Journal  of over 7,400 patients who had knee replacement surgery found the procedure often had minimal effects on quality of life and wasn’t worth the cost.

Arthroscopic surgery is less invasive than a total knee replacement, but studies also show it is often not effective. In 2017, an international panel of experts reviewed 25 studies involving nearly two million patients and concluded that arthroscopic surgery does not improve long term pain or function in patients with knee conditions such as osteoarthritis.

Because these conventional treatments often fail, there is growing interest in the use of stem cells to treat knee problems. The FDA, however, takes a dim view of autologous stem cells and released guidance in 2017 that requires the cells to undergo “minimal manipulation.”

The FDA recently sent letters to 20 stem cell manufacturers and clinics warning them they were violating FDA regulations. The agency says the science behind autologous cells is still in its early stages and they have not been proven to be safe and effective.

“There’s a false premise being asserted by some in the field that a product derived from a person’s own body and then manipulated and reinserted for another use different from the one it played in its original location is not subject to FDA regulation just because it originated from the person it was given back to,” then FDA commissioner Scott Gottlieb, MD, and Biologics Center Director Peter Marks, MD, said in a statement.

“We’ve seen too many cases of sponsors claiming that cells aren’t subject to FDA regulation just because the cells originated from the same patient to whom the eventual manufactured product is being given. And we’ve seen too many cases of companies making unsubstantiated claims that these treatments prevent, treat, cure or mitigate disease where the products have sometimes led to serious patient harm.”

Elite Hospitals Offering Unproven Stem Cell Treatments

By Liz Szabo, Kaiser Health News

The online video seems to promise everything an arthritis patient could want.

The six-minute segment mimics a morning talk show, using a polished TV host to interview guests around a coffee table. Dr. Adam Pourcho extols the benefits of stem cells and “regenerative medicine” for healing joints without surgery. Pourcho, a sports medicine specialist, says he has used platelet injections to treat his own knee pain, as well as a tendon injury in his elbow. Extending his arm, he says, “It’s completely healed.”

Brendan Hyland, a gym teacher and track coach, describes withstanding intense heel pain for 18 months before seeing Pourcho. Four months after the injections, he says, he was pain-free and has since gone on a 40-mile hike.

“I don’t have any pain that stops me from doing anything I want,” Hyland says.

The video’s cheerleading tone mimics the infomercials used to promote stem cell clinics, several of which have recently gotten into hot water with federal regulators, said Dr. Paul Knoepfler, a professor of cell biology and human anatomy at the University of California-Davis School of Medicine.

But the marketing video wasn’t filmed by a little-known operator. It was sponsored by Swedish Medical Center, the largest nonprofit health provider in the Seattle area.

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Swedish is one of a growing number of respected hospitals and health systems—including the Mayo Clinic, the Cleveland Clinic and the University of Miami—that have entered the lucrative business of stem cells and related therapies. Typical treatments involve injecting patients’ joints with their own fat or bone marrow cells, or with extracts of platelets, the cell fragments known for their role in clotting blood. Many patients seek out regenerative medicine to stave off surgery, even though the evidence supporting these experimental therapies is thin at best, Knoepfler said.

Hospitals say they’re providing options to patients who have exhausted standard treatments. But critics suggest the hospitals are exploiting desperate patients and profiting from trendy but unproven treatments.

The Food and Drug Administration is attempting to shut down clinics that hawk unapproved stem cell therapies, which have been linked to several cases of blindness and at least 12 serious infections. Although doctors usually need preapproval to treat patients with human cells, the FDA has carved out a handful of exceptions, as long as the cells meet certain criteria, said Barbara Binzak Blumenfeld, an attorney who specializes in food and drug law at Buchanan Ingersoll & Rooney in Washington.

Hospitals like Mayo are careful to follow these criteria, to avoid running afoul of the FDA, said Dr. Shane Shapiro, program director for the Regenerative Medicine Therapeutics Suites at Mayo Clinic's campus in Florida.

‘Expensive Placebos’

While hospital-based stem cell treatments may be legal, there’s no strong evidence they work, said Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics who has published a series of articles describing the size and dynamics of the stem cell market.

“FDA approval isn’t needed and physicians can claim they aren’t violating federal regulations,” Turner said. “But just because something is legal doesn’t make it ethical.”

For doctors and hospitals, stem cells are easy money, Turner said. Patients typically pay more than $700 a treatment for platelets and up to $5,000 for fat and bone marrow injections. As a bonus, doctors don’t have to wrangle with insurance companies, which view the procedures as experimental and largely don’t cover them.

It’s lucrative. It’s easy to do. All these reputable institutions, they don’t want to miss out on the business. It preys on people’s desperation.
— Dr. James Rickert

“It’s an out-of-pocket, cash-on-the-barrel economy,” Turner said. Across the country, “clinicians at elite medical facilities are lining their pockets by providing expensive placebos.”

Some patient advocates worry that hospitals are more interested in capturing a slice of the stem-cell market than in proving their treatments actually work.

“It’s lucrative. It’s easy to do. All these reputable institutions, they don’t want to miss out on the business,” said Dr. James Rickert, president of the Society for Patient Centered Orthopedics, which advocates for high-quality care. “It preys on people’s desperation.”

In a joint statement, Pourcho and Swedish defended the online video.

“The terminology was kept simple and with analogies that the lay person would understand,” according to the statement. “As with any treatment that we provide, we encourage patients to research and consider all potential treatment options before deciding on what is best for them.”

But Knoepfler said the guests on the video make several “unbelievable” claims.

At one point, Dr. Pourcho says that platelets release growth factors that tell the brain which types of stem cells to send to the site of an injury. According to Pourcho, these instructions make sure that tissues are repaired with the appropriate type of cell, and “so you don’t get, say, eyeball in your hand.”

Knoepfler, who has studied stem cell biology for two decades, said he has never heard of “any possibility of growing eyeball or other random tissues in your hand.” Knoepfler, who wrote about the video in February on his blog, The Niche, said, “There’s no way that the adult brain could send that kind of stem cells anywhere in the body.”

The marketing video debuted in July on KING-TV, a Seattle station, as part of a local lifestyles show called “New Day Northwest.”

Although much of the show is produced by the KING 5 news team, some segments—like Pourcho’s interview—are sponsored by local advertisers, said Jim Rose, president and general manager of KING 5 Media Group.

After being contacted by KHN, Rose asked Swedish to remove the video from YouTube because it wasn’t labeled as sponsored content. Omitting that label could allow the video to be confused with news programming. The video now appears only on the KING-TV website, where Swedish is labeled as the sponsor.

“The goal is to clearly inform viewers of paid content so they can distinguish editorial and news content from paid material,” Rose said. “We value the public’s trust.”

Increasing Scrutiny

Federal authorities have recently begun cracking down on doctors who make unproven claims or sell unapproved stem cell products.

In October, the Federal Trade Commission fined stem cell clinics millions of dollars for deceptive advertising, noting that the companies claimed to be able to treat or cure autism, Parkinson’s disease and other serious diseases.

In a recent interview Scott Gottlieb, the FDA commissioner, said the agency will continue to go after what he called “bad actors.”

With more than 700 stem cell clinics in operation, the FDA is first targeting those posing the biggest threat, such as doctors who inject stem cells directly into the eye or brain.

“There are clearly bad actors who are well over the line and who are creating significant risks for patients,” Gottlieb said.

Products are being promoted that aren’t providing any proven benefits and where patients are paying out-of-pocket.
— Scott Gottlieb, FDA Commissioner

Gottlieb, set to leave office April 5, said he’s also concerned about the financial exploitation of patients in pain.

“There’s economic harm here, where products are being promoted that aren’t providing any proven benefits and where patients are paying out-of-pocket,” Gottlieb said.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said there is a broad “spectrum” of stem cell providers, ranging from university scientists leading rigorous clinical trials to doctors who promise stem cells are “for just about anything.” Hospitals operate somewhere in the middle, Marks said.

“The good news is that they’re somewhat closer to the most rigorous academics,” he said.

The Mayo Clinic’s regenerative medicine program, for example, focuses conditions such as arthritis, where injections pose few serious risks, even if that’s not yet the standard of care, Shapiro said.

Rickert said it’s easy to see why hospitals are eager to get in the game.

The market for arthritis treatment is huge and growing. At least 30 million Americans have the most common form of arthritis, with diagnoses expected to soar as the population ages. Platelet-rich plasma (PRP) injections for arthritis generated more than $93 million in revenue in 2015, according to an article last year in The Journal of Knee Surgery.

“We have patients in our offices demanding these treatments,” Shapiro said. “If they don’t get them from us, they will get them somewhere else.”

Doctors at the Mayo Clinic try to provide stem cell treatments and similar therapies responsibly, Shapiro said. In a paper published this year, Shapiro described the hospital’s consultation service, in which doctors explain patients’ options and clear up misconceptions about what stem cells and other injections can do. Doctors can refer patients to treatment or clinical trials.

“Most of the patients do not get a regenerative [stem cell] procedure,” Shapiro said. “They don’t get it because after we have a frank conversation, they decide, ‘Maybe it’s not for me.’”

Lots of Hype, Little Proof

Although some hospitals boast of high success rates for their stem cell procedures, published research doesn’t back up those claims, Rickert said.

The Mayo Clinic website says that 40 to 70 percent of patients “find some level of pain relief.” Atlanta-based Emory Healthcare claims that 75 to 80 percent of patients “have had significant pain relief and improved function.” In the Swedish video, Pourcho claims “we can treat really any tendon or any joint” with PRP.

The strongest evidence for PRP is in pain relief for arthritic knees and tennis elbow, where it appears to be safe and perhaps helpful, said Dr. Nicolas Piuzzi, an orthopedic surgeon at the Cleveland Clinic.

But PRP hasn’t been proven to help every part of the body, he said.

PRP has been linked to serious complications when injected to treat patellar tendinitis, an injury to the tendon connecting the kneecap to the shinbone. In a 2013 paper, researchers described the cases of three patients whose pain got dramatically worse after PRP injections. One patient lost bone and underwent surgery to repair the damage.

“People will say, ‘If you inject PRP, you will return to sports faster,’” said Dr. Freddie Fu, chairman of orthopedic surgery at the University of Pittsburgh Medical Center. “But that hasn’t been proven.”

A 2017 study of PRP found it relieved knee pain slightly better than injections of hyaluronic acid. But that’s nothing to brag about, Rickert said, given that hyaluronic acid therapy doesn’t work, either. While some PRP studies have shown more positive results, Rickert notes that most were so small or poorly designed that their results aren’t reliable.

In its 2013 guidelines for knee arthritis, the American Academy of Orthopaedic Surgeons said it is “unable to recommend for or against” PRP.

“PRP is sort of a ‘buyer beware’ situation,” said Dr. William Li, president and CEO of the Angiogenesis Foundation, whose research focuses on blood vessel formation. “It’s the poor man’s approach to biotechnology.”

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Tests of other stem cell injections also have failed to live up to expectations.

Shapiro published a rigorously designed study last year in Cartilage, a medical journal, that found bone marrow injections were no better at relieving knee pain than saltwater injections. Rickert noted that patients who are in pain often get relief from placebos. The more invasive the procedure, the stronger the placebo effect, he said, perhaps because patients become invested in the idea that an intervention will really help. Even saltwater injections help 70 percent of patients, Fu said.

A 2016 review in the Journal of Bone and Joint Surgery concluded that “the value and effective use of cell therapy in orthopaedics remain unclear.” The following year, a review in the British Journal of Sports Medicine concluded, “We do not recommend stem cell therapy” for knee arthritis.

Shapiro said hospitals and health plans are right to be cautious.

“The insurance companies don’t pay for fat grafting or bone-marrow aspiration, and rightly so,” Shapiro said. “That’s because we don’t have enough evidence.”

Rickert, an orthopedist in Bedford, Indiana, said fat, bone marrow and platelet injections should be offered only through clinical trials, which carefully evaluate experimental treatments. Patients shouldn’t be charged for these services until they’ve been tested and shown to work.

Orthopedists—surgeons who specialize in bones and muscles—have a history of performing unproven procedures, including spinal fusion, surgery for rotator cuff disease and arthroscopy for worn-out knees, Turner said. Recently, studies have shown them to be no more effective than placebos.

Misleading Marketing

Some argue that joint injections shouldn’t be marketed as stem cell treatments at all.

Piuzzi said he prefers to call the injections “orthobiologics,”noting that platelets are not even cells, let alone stem cells. The number of stem cells in fat and bone marrow injections is extremely small, he said.

Patients are attracted to regenerative medicine because they assume it will regrow their lost cartilage, Piuzzi said. There’s no solid evidence that the commercial injections used today spur tissue growth, Piuzzi said. Although doctors hope that platelets will release anti-inflammatory substances, which could theoretically help calm an inflamed joint, they don’t know why some patients who receive platelet injections feel better, but others don’t.

So, it comes as no surprise that many patients have trouble sorting through the hype.

Florida resident Kathy Walsh, 61, said she wasted nearly $10,000 on stem cell and platelet injections at a Miami clinic, hoping to avoid knee replacement surgery.

When Walsh heard about a doctor in Miami claiming to regenerate knee cartilage with stem cells, “it seemed like an answer to a prayer,” said Walsh, of Stuart, Florida. “You’re so much in pain and so frustrated that you cling to every bit of hope you can get, even if it does cost you a lot of money.”

The injections eased her pain for only a few months. Eventually, she had both knees replaced. She has been nearly pain-free ever since. “My only regret,” she said, “is that I wasted so much time and money.”

Kaiser Health News (KHN) is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

12 Patients Sickened by Contaminated Stem Cells

By Pat Anson, PNN Editor

At least a dozen patients undergoing stem cell therapy developed bacterial infections after being injected with unapproved stem cell products, according to the Food and Drug Administration. Most of the patients were being treated for chronic back and joint pain.

All 12 patients were hospitalized, but there were no deaths. Seven of the infections were in Texas, four in Florida and one was in Arizona.  CDC investigators found E. coli bacteria in unopened vials at two of the stem cell clinics where the patients were treated.   

All of the patients received stem cells derived from umbilical cords that were initially processed by Genetech, a San Diego stem cell manufacturer.  The stem cells were recalled in October and the FDA sent a warning letter to Genetech last month saying its donor selection, manufacturing and safety standards were deficient.

“In this case, the company’s failure to put in place appropriate safeguards may have led to serious blood infections in patients,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

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This week the FDA also sent letters to 20 other stem cell providers warning them that the agency would step up its enforcement of guidelines for cell-based regenerative medicine. The FDA has long taken a dim view of newer stem cell therapies that have not undergone clinical testing, but said it would use “enforcement discretion” as long as a new treatment does not pose a significant safety risk.

“The letters we’re issuing today to manufacturers, health care providers and clinics around the country are a reminder that there’s a clear line between appropriate development of these products and practices that sidestep important regulatory controls needed to protect patients. Time is running out for firms to come into compliance during our period of enforcement discretion,” Gottlieb said.  

Gottlieb has previously warned of “unscrupulous actors” in the stem cell industry that deceive patients with “dangerously dubious products.” Critics have complained the agency's "go slow" approach to regnerative medicine has delayed the development of promising new treatments for autoimmune diseases, cancer, diabetes, neuropathy, back pain and other illnesses.  

New Spinal Discs Grown from Stem Cells

By Steve Weakley

Scientists have moved a step closer to being able to replace degenerated spinal discs with new ones grown in a laboratory from a patient’s own stem cells.

Spinal discs are soft tissues that cushion the vertebrae and enable our backs to conform and perform the tasks of everyday movement. Over time, the discs can wear out and cause the bones of the spine to rub together and pinch nerves. This disc degeneration is one of the leading causes of back pain.

University of Pennsylvania researchers reported in the journal Science Translational Medicine that they have successfully grown and implanted replacement discs made from the stem cells of goats. The cells were grown in a laboratory in a disc shaped form and then implanted into the necks of goats.

After 8 weeks, MRI’s showed that the replacement discs functioned just as well or better than the goats’ original cervical discs. The implanted discs were left in for 20 weeks and became part of the animals’ own tissue.

Researchers told Medical News Today that this was a major step forward from previous experiments in which they implanted discs into rat tails. Goat discs are more comparable to humans in size, structure and function.

"I think it's really exciting that we have come this far, from the rat tail all the way up to human-sized implants," said co-senior author Harvey Smith, MD, a professor of Orthopaedic Surgery at the Hospital of the University of Pennsylvania.  

"Using a true tissue-engineered motion-preserving replacement device is not something we have yet done in orthopaedics. I think it would be a paradigm shift for how we really treat these spinal diseases and how we approach motion sparing reconstruction of joints.”

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Current treatments for degenerative discs include spinal fusion or artificial implants.  Both have limited benefits and usually cannot restore full functionality. Artificial implants also break down and have be replaced.

"The current standard of care does not actually restore the disc, so our hope with this engineered device is to replace it in a biological, functional way and regain full range of motion," said co-senior author Robert Mauck, PhD, a professor for Education and Research in Orthopaedic Surgery.

"This is a major step, to grow such a large disc in the lab, to get it into the disc space, and then to have it to start integrating with the surrounding native tissue. That's very promising."

The researchers say the next step is longer and more extensive tests on goats, before working on a bioengineered human model.  If those tests are successful, they eventually hope to test the implants in human trials.

"We have every reason to be optimistic, and if it works, we can change the way we think about treating some of these disc diseases," said Smith.

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. 

KELLY OSBOURNE

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.

TAREK EL MOUSSA

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.”