Professional Athletes Get Stem Cell Therapy, But Should You?

By Liz Szabo, Kaiser Health News

Baseball superstar Max Scherzer — whose back injury has prevented him from pitching for the Washington Nationals since he last played on July 25 — is the latest in a long list of professional athletes to embrace stem cell injections in an attempt to accelerate their recovery.

But many doctors and ethicists worry that pro athletes — who have played a key role in popularizing stem cells — are misleading the public into thinking that the costly, controversial shots are an accepted, approved treatment.

“It sends a signal to all the fans out there that stem cells have more value than they really do,” said Dr. James Rickert, president of the Society for Patient Centered Orthopedics, which advocates for high-quality care. “It’s extremely good PR for the people selling this kind of thing. But there’s no question that this is an unproven treatment.”

Stem cells and related therapies, such as platelet injections, have been used for the past decade by top athletes: golfer Tiger Woods, tennis pro Rafael Nadal, hockey legend Gordie Howe, basketball player Kobe Bryant and NFL quarterback Peyton Manning. Stem cells are offered at roughly 1,000 clinics nationwide, as well as at some of the country’s most respected hospitals.

Depending on the treatment, the cost can range from hundreds to thousands of dollars. Insurance does not cover the treatments in most cases, so patients pay out of pocket.

Yet for all the hype, there’s no proof it works, said Paul Knoepfler, a professor in the department of cell biology and human anatomy at the University of California at Davis.

By    Arturo Pardavila III     from Hoboken, NJ, USA

By Arturo Pardavila III from Hoboken, NJ, USA

Referring to Scherzer, Knoepfler said, “There’s really not much evidence that it’s going to help him, other than as a psychological boost or as a placebo effect.”

Scherzer, 35, said he received a stem cell shot Friday for a mild strain in his upper back and shoulder. According to a news story on the Major League Baseball website, Scherzer also previously had a stem cell injection to treat a thumb injury.

If the diagnosis of Scherzer’s mild muscle strain is correct, it should completely heal itself with 10 days of rest, Rickert said, so Scherzer would probably feel ready to play by Monday even without the stem cells. But Rickert said he worries about other athletes who are tempted to return to the field too soon.

“The risk from the stem cell procedure is that it could give someone a false sense of confidence, and they could go back to play too early” and reinjure themselves, he said.

A spokeswoman for the Washington Nationals declined to provide information about Scherzer’s treatment, such as the type of stem cells used or the name of the clinician who administered them.

Clinics that offer stem cell treatments prepare injections by withdrawing a person’s fat or bone marrow, then processing the cells and injecting them back into aching joints, tendons or muscles.

Another popular treatment involves concentrating platelets — the cells that help blood clot. Many people confuse platelet injections with stem cell injections, perhaps because the shots are promoted as treatments for similar conditions, said Dr. Kelly Scollon-Grieve, a physical medicine and rehabilitation specialist at Premier Orthopaedics in Havertown, Pa.

Placebo Effect on Pain

When it comes to pain, injections can act as powerful placebos, partly because suffering patients put so much faith in treatment, said Dr. Nicholas DiNubile, an orthopedic surgeon and former consultant for the Philadelphia 76ers.

In a recent analysis, more than 80% of patients with knee arthritis perceived a noticeable improvement in pain after receiving a placebo of simple saline shots.

Team doctors often treat athletes with a variety of therapies, in the hope of getting them quickly back on the field, said Arthur Caplan, director of the division of medical ethics at New York University School of Medicine. Athletes may assume that stem cells are responsible for their recovery, when the real credit should go to other remedies, such as ice, heat, nonsteroidal anti-inflammatory medications, cortisone shots, massage, physical therapy or simple rest.

“These are the richest, most highly paid athletes around,” Caplan said. (Scherzer and the Nats agreed to a $210 million, seven-year contract in 2015.) “So anything you can think of, they’re getting. But I wouldn’t use them as a role model for how to treat injuries.”

While athletes often talk about their stem cell treatments, Caplan said he wonders, “Would the inflammation or problem have just gone away on its own?”

Sports fans shouldn’t expect to have the same reaction to stem cells — or any medical intervention — as a professional athlete, DiNubile said.

In general, athletes recover far more rapidly than other people, just because they’re so young and fit, DiNubile said. The genes and training that propelled them to the major leagues may also aid in their recovery. “They have access to the best care, night and day,” DiNubile said.

Whenever a top athlete is treated with stem cells, word spreads quickly on social media. Fans often end up doing the stem cell industry’s marketing for them: A 2015 analysis found that 72% of tweets about Gordie Howe’s stem cell treatments were positive. Of 2,783 tweets studied, only one mentioned that Howe’s treatment, delivered in Mexico after Howe’s stroke, was unproved and not approved by the U.S. Food and Drug Administration. Howe died in 2016.

The Mexican stem cell clinic provided Howe’s treatment at no charge. Clinics use such donations as a form of marketing, because they generate priceless publicity, said Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics who has published articles describing the size and dynamics of the stem cell market.

“Clinics provide free stem cell treatments or offer procedures at a discounted rate, and in return they can generate YouTube testimonials, press releases and positive media coverage,” Turner said. “It’s also a good way to build relationships with wealthy individuals and get them to refer friends and family members for stem cell procedures.”

Stem cell clinics often feature athletes and other celebrities on their websites and in marketing materials.

In a 2018 column, Los Angeles Times writer Michael Hiltzik noted that stem cell treatment has failed three baseball players with the Los Angeles Angels. Players Shohei Ohtani, Andrew Heaney and Garrett Richards, who is no longer with the Angels, tried stem cells in the past three years in an effort to avoid surgery. All ended up needing surgery anyway.

As DiNubile said, “the marketing is clearly ahead of the science, no question.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Stem Cell Fearmongering

By A. Rahman Ford, PNN Columnist

In a recent Canadian Medical Association Journal case report, Canadian researchers report the case of a 38-year-old man who suffered an adverse event from a very specific form of stem cell therapy – an olfactory mucosa graft.

Rather than simply present the medical particulars of the case itself, the authors proceed to make a broad indictment of stem cell therapy (SCT) as a whole. This politicization is unnecessary, irresponsible and patently unscientific.

Furthermore, it undermines the objectivity of the research itself and regrettably continues the trend of SCT fearmongering prevalent in certain mainstream publications like STAT and the Los Angeles Times, which immediately ran with the story, pushing a fear-based narrative.

In the procedure in question, nasal cells were transplanted into a spinal cord lesion that resulted from a spinal fraction that occurred when the patient was 20 years old, leaving him partially paralyzed .

He had the olfactory mucosa graft in Portugal at age 26 to potentially treat his pain and paralysis. The treatment was unsuccessful.

A dozen years later, the patient experienced deteriorating neurological function and doctors discovered a large mass on his spine “with mucinious material and tissue consistent with ectopic olfactory mucosa.”

This discovery confirmed the doctors’ preoperative diagnosis that the spinal mass was related to the stem cell procedure the patient had undergone years prior.

If the authors had stopped there, this could be considered an important contribution to the stem cell literature. Cases of adverse events from any medical procedure should be reported and taken seriously.

Unfortunately, the authors proceed much further to extrapolate wildly from their one very unique case of a very specific and experimental form of SCT. Rather than present the data and their scientific analysis, they stray into the political, diminishing the overall value of their work. Sadly, the paper reads more like an op-ed rather than objective peer-reviewed research.

The paper’s most glaring and egregious problem is that it lumps all forms of SCT together with no mention of the different types of cells, different tissues those cells come from, different methods of administration of those cells, and the differences in the clinics offering those therapies. These distinctions are critical and the authors’ failure to discuss them is troubling to say the least.  

Instead, the authors condemn the stem cell “industry” in toto, lumping cosmetic and medical procedures together, with no justification as to why the two are technically comparable, and lamenting the phantom maelstrom of SCT adverse advents that curiously has yet to materialize.

The authors then make a rather supreme leap in logic with the unsubstantiated claim that, “although some of the reported adverse events might relate to surgical technique alone, others are likely the direct result of the yet unproven treatments using stem cells.”

They provide absolutely no evidentiary basis for such a sweeping claim. If a claim cannot be supported by evidence then it should not be made. Otherwise, anyone who reads the claim might be left to make reasonable inferences about professionalism, undisclosed subjectivities and possible hidden agendas.

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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.

The Push for Stem Cell Censorship Has Begun

By A. Rahman Ford, PNN Columnist

A new study published in journal Stem Cell Reports, entitled “How to Peddle Hope: An Analysis of YouTube Patient Testimonials of Unproven Stem Cell Treatments,” looks at over a hundred videos by stem cell patients posted on YouTube. 

The study appears to have an underlying anti-democratic agenda – to shame YouTube and other internet platforms into removing positive patient testimonials about stem cell therapy (SCT).  Indeed, the use of the pejorative term “peddle” in the article’s title immediately undermines the study’s credibility.

This research epitomizes how propaganda can masquerade as scientific research, and how data can be twisted to meet its masters’ agenda.

The study comes on the heels of a recent federal judge’s decision that the FDA could regulate stem cells made from adipose tissue – a patient’s own fat cells. Although SCT critics generally praised the ruling as a victory for government oversight, outlets like the Washington Post lamented that it would likely not deter clinics from offering the therapy. 

A New York Times article accused the FDA of not acting until patients were harmed, and using enforcement actions that consist only of warning letters without any real teeth.  

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STAT News even criticized the National Institutes of Health for allowing stem cell clinics to “co-opt” the nation’s clinical trial database.

Stem cell critics have apparently realized that the three previous stages of their vilification campaign have failed. These stages were:

  1. Vilify the patients:  Promote the condescending narrative that patients are desperate, ignorant and too stupid to research stem cell therapy for themselves and decide whether it is best for them.

  2. Vilify the clinics: Stem cell clinics are run by shady charlatans who engage in duplicitous business practices that take advantage of desperate, ignorant and pitiful Americans by selling them “unproven” products that couldn’t possibly help them.

  3. Vilify the federal government: Federal agencies have not acted quickly or robustly enough to enforce the regulations that govern regenerative medicine, thus tacitly approving the growing “wild west” of clinics offering SCT.

The Push for YouTube Censorship

Critics now appear to be setting their sights on a fourth vilification stage.  In their desperation, they have decided to take a more authoritarian turn towards internet censorship.

The new study’s authors examined 159 YouTube testimonials from patients who had SCT for ALS, multiple sclerosis, Parkinson’s, cerebral palsy and spinal cord injury.  Not surprisingly, they found that most of the videos were published by providers and nearly all discussed the benefits of SCT in improving pain, overall health and quality of life. 

The authors concluded the YouTube testimonials “may be a potent marketing tool” and “are likely to have a wider reach and significant impact on influencing health behavior.” 

The article’s final sentence reveals the authors’ true motive: “Adopting multiple approaches, including patient education, enhancing patient treatment options, and regulatory oversight, are required to make a significant dent in reducing the number of clinics providing unproven SCTs.”

Setting aside the numerous, glaring and egregious methodological shortcomings of the study, the more important issue is one of broader public policy.  These authors appear to be implicitly advocating that YouTube and other internet sites censor videos that are “misleading” or “deceptive” or not published by “reputable organizations.” 

And who or what is to determine whether any particular video meets this criteria?  Wired published an article with the ominous headline “YouTube Testimonials Lure Patients to Shady Stem Cell Clinics,” implicitly calling on YouTube to take action. The notion isn’t farfetched. YouTube has been in the news a lot recently for censoring videos, using nebulous criteria and subjective standards.   

Apparently, SCT critics have jumped on the YouTube censorship bandwagon.  It’s a wagon that seems to claim a new victim every day, and its victims are usually those who threaten the status quo.  Unfortunately, it’s a wagon that travels the pothole-riddled road of authoritarianism.  It’s a road patrolled by people in strange uniforms, with sophisticated and articulate weapons, who dispense a vicious propaganda, and who always claim to have your best interest at heart.

Please make sure to call, email and/or tweet your state and federal legislators to voice your support for the availability and affordability of stem cell therapy.  The people who suffer with pain and disability will not be silenced and will not be censored.  Our democratic voice will be the response to their authoritarianism.

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.

Employers Adding Stem Cell Options to Insurance Plans

By Liz Szabo, Kaiser Health News

A Midwestern grocery chain, Hy-Vee, is taking an unusual approach to reducing health care costs. Before employees in certain cities can undergo knee replacement, they first must visit a stem cell provider.

Hy-Vee has contracted with one of the United States’ leading stem cell companies — Regenexx, based in Des Moines, Iowa — that claims injections of concentrated bone marrow or platelets can help patients avoid expensive joint surgery.

Regenexx has persuaded over 100 employers to include its services in their health insurance plans. In a marketing booklet, Regenexx, whose injections range in price from $1,500 to $9,000, notes that its treatments cost a fraction of major surgery.

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A single knee replacement ranges from $19,000 to $30,000 in the U.S.

Health insurance typically doesn’t cover stem cell injections, with the exception of certain accepted treatments, such as bone-marrow transplants for cancer and aplastic anemia.

Aetna, the United States’ third-largest health insurer, dismisses stem cells and platelet injections as experimental; Anthem, the country’s second-biggest health insurance provider, classifies the injections as “not medically necessary.” Without insurance coverage, patients are forced to pay out-of-pocket or forgo treatment.

So instead of dealing with disapproving insurance executives, Regenexx appeals directly to employers large enough to fund their own health plans. These businesses have the freedom to customize their plans, covering services that aren’t part of a standard insurance package.

In a statement, Regenexx said its goal is to “replace more invasive surgical orthopedics” with nonsurgical options, noting that recent research has found many joint operations are ineffective. On its website, Regenexx claims its procedures “repair and regenerate damaged or degenerated bone, cartilage, muscle, tendons, and ligaments.”

In a bone marrow stem cell procedure, for example, a doctor withdraws bone marrow cells from a patient’s hip, concentrates them, then reinjects them into a problem area, such as an arthritic knee. Doctors target the exact location in the joint using ultrasound. For a “platelet-rich plasma” treatment, doctors draw blood, concentrate the platelets, then inject them into the target area.

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Regenexx, previously known as Regenerative Sciences, is one of the oldest stem cell companies in the U.S. When it opened its doors in 2005, it had only a handful of competitors.

Today, there are more than 1,000 stem clinics in the U.S., said Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics, who has published a series of articles describing the stem cell market.

At times, Regenexx has clashed with the Food and Drug Administration. In 2010, for example, Regenexx sued the FDA, claiming the agency lacked the authority to regulate its procedures, which involved culturing stem cells before reinjecting them into patients. Regenexx lost its case and was countersued by the FDA, which charged that Regenexx was marketing an unapproved drug. In 2014, the U.S. Court of Appeals in Washington sided with the FDA, forcing Regenexx to stop performing the controversial procedures.

Today, Regenexx performs this procedure only in the Cayman Islands, where the government allows it. The Cayman Islands, where there is less government regulation of health care, has become known as a medical tourism destination, Turner said.

Regenexx says that the treatments offered at its U.S. clinics comply with FDA regulations, which require that cells injected into patients undergo no more than “minimal manipulation.”

On its website, Regenexx lists more than two dozen studies led by its doctors. For example, its chief medical officer, Dr. Chris Centeno, published a small study last year that found patients with knee arthritis who received bone marrow and platelets fared better than those randomly assigned to exercise therapy.

Other research suggests stem cells and platelets may work no better than placebos. In a recent analysis, over 80% of patients with knee arthritis experienced a noticeable improvement in pain after receiving simple saltwater injections.

There’s also no definitive evidence stem cells and platelets can regrow lost cartilage. A 2018 review concluded platelets have “marginal effectiveness,” and experts note that most published studies are so small or poorly designed that their results aren’t reliable.

Corporate Boosters

Corporate executives have become some of Regenexx’s biggest boosters. Hy-Vee’s former chairman and CEO, Ric Jurgens, appears in a Regenexx marketing brochure and says that he turned to Regenexx because of heel pain. The brochure, which was removed from a Regenexx website after Kaiser Health News began reporting this story, quotes Jurgens as saying, “I knew that giving our employees the chance to explore options besides surgery was in their best interest.”

Hy-Vee did not make Jurgens or other employees available to interview.

Perhaps Regenexx’s best-known corporate client is Des Moines-based Meredith Corp., which owns multiple TV and radio stations, as well as magazines such as Better Homes & Gardens.

Steve Lacy, Meredith’s former CEO and current board chairman, said he underwent a Regenexx procedure two years after his company began covering stem cell treatments. He had been facing knee surgery and thought stem cells were worth a try.

The procedure got him back to doing everything he wants to do, Lacy said, even running several days a week. He also has done daily physical therapy for over two years. “The rehab and recovery is far less onerous” with the Regenexx procedure than with surgery, Lacy said. “If the procedure doesn’t work for an individual, there’s no harm.”

Meredith has spent about $400,000 in four years on 85 employees who have had Regenexx treatments, or about $4,700 a patient, said Meredith spokesman Art Slusark. That’s a small share of the roughly $75 million a year that Meredith spends on its medical plan, he said.

At its headquarters, Meredith has promoted Regenexx procedures through email, posters and “lunch-and-learn” sessions in the office, said Jenny McCoy, Meredith’s corporate communications director.

McCoy herself has become a poster child for Regenexx’s benefits. She and two other Meredith employees appear with Lacy in a marketing video on the Regenexx site:

Although McCoy had begun to experience knee and hip pain during exercise, she said in an interview that her pain was not severe enough to need surgery. McCoy underwent platelet injections two years ago and is pain-free today, she said.

“I thought, ‘If Meredith is covering it, I might as well have it done early before [the pain] causes me too many problems,’” said McCoy, 52. Given the price tag, she said, “I would not have done it otherwise. I wouldn’t have even known about it.”

‘Very Pushy’ Marketing

Some employers are, in fact, skeptical. The Des Moines Public Schools has opted not to add Regenexx to its employee health plan, said Catherine McKay, director of employee services for the school system. She said a salesman for a local stem cell clinic, which has since merged with Regenexx, told her the treatments could save the school system lots of money. McKay wasn’t sold.

“My experience with them has not been great, in terms of marketing and sales. They’re very, very pushy,” McKay said. “They claim they can get people back to work earlier” than surgery. “But if I still need knee surgery a year down the road, that doesn’t cut my costs.”

The Des Moines school system has agreed to consider covering Regenexx procedures as part of its workers’ compensation program on a case-by-case basis, McKay said. The school system has not signed a contract with Regenexx, however, and hasn’t included Regenexx in its health plan.

McKay said she knows of two school employees who have tried Regenexx. While one employee was satisfied with the results, McKay said, another “went through a couple procedures and ended up needing surgery anyway.” 

In response, Regenexx noted that many patients who undergo knee surgery are also unhappy with the results. Research suggests that up to one-third of those who have knees replaced continue to experience chronic pain, while one-fifth report that they are dissatisfied with the results of their surgery.

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

Why Stem Cell Critics Are Wrong

By A. Rahman Ford, PNN Columnist

In a recent and rather lengthy New York Times article entitled “Stem Cell Treatments Flourish With Little Evidence That They Work,” authors Denise Grady and Reed Ableson do their absolute best to convince their readers that stem cell therapy (SCT) is based on strange, magical hocus-pocus, and its practitioners are all mad scientists. 

They portray stem cell clinics as shadowy castle dungeons lit only by the occasional lightning strike, and filled with glass beakers that froth with fluorescent-colored liquids.  The authors even use the phrase “unproven cell cocktails.”  That little piece of anti-SCT propaganda even scares me a little, and I’ve had SCT.

In the article, the authors trot out the same tired, empty and underhanded tropes that all articles of its ilk like to employ:

  • “no clear evidence that these treatments work”

  • “gotten way ahead of the science”

  • “no regulatory oversight”

  • “rogue clinics”

  • “scant data”

  • “not covered by insurance”

  • “high risk”  

  • “lack of solid medical evidence”

  • “snake oil”

A recent New Yorker article isn’t much different.  Both articles do contain some valid points, but those points are obscured by the scare tactics, fear-charged language and cherry-picked patient cases.

These SCT hit pieces appear from time-to-time, but rarely in publications with the broad readership of the New York Times and the New Yorker.  After reading so many of them over the years, I began to wonder – if stem cell clinics are flourishing, then isn’t that a tacit admission that the fear-mongering isn’t working? 

And if the fear-mongering isn’t working, why do they keep publishing these less-than-objective articles?  

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Maybe it’s because they feel like they are part of some consumer protection vanguard to protect Americans from sleazy medical charlatans.  Or maybe it’s because the scare tactics have failed and they have no idea what else to do. 

The fact is, as I wrote in a recent PNN column, the SCT tipping point appears to have been reached. The American public simply isn’t buying what the critics are selling. As many as 1,000 stem cell clinics are now operating in the United States, according to The Washington Post, which predicts the industry is “likely to flourish” despite a judge’s ruling that upheld the FDA’s authority to regulate — and stifle — the industry.    

The Basquiat Effect

But it gets even worse for the anti-SCT purveyors. They may be suffering from what I refer to as the Basquiat Effect.  Jean-Michel Basquiat was a graffiti-inspired painter, sculptor and musician who rose to prominence in the 1980s in New York City. 

Basquiat’s work is laden with social and political commentary, with primordial figures, abstract arrangements and linguistic devices.  One of his more popular motifs was to write words and cross them out. 

Why did he do this?  As quoted from the documentary Jean-Michel Basquiat: Radiant Child, “I cross out words so you will see them more.  The fact that they are obscured makes you want to read them.”

One of Basquiat’s paintings recently sold for $110.5 million.  He was clearly on to something.

Put simply, the Basquiat Effect holds that the more one tries to hide something, the more the people they are trying to hide it from pay attention to it.  This effect becomes even more powerful after the phenomenon that is attempting to be hidden reaches it tipping point. 

Because the American public’s curiosity is already piqued, any mention of the phenomenon, regardless of context, compels the reader to look into it. The principle seems counter intuitive, but SCT critics may have provided a perfect example.  The New York Times and New Yorker articles may actually drive more people toward SCT rather than away. 

One of Basquiat’s trademark graffiti tags was “SAMO,” short for “Same Old.”  It essentially illustrated his disenchantment with the prevailing cultural orthodoxy and his intention to introduce something new, radical and revolutionary as a solution. 

In the same way, SCT is a radical response to the failures of medical orthodoxy. The “SAMO” pills and surgeries that exemplify the “treatment” approach to healthcare have given way to an expanding desire by the American people for procedures that actually “cure” chronic conditions and don’t just mask their symptoms.

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The best approach for the anti-SCT purveyors may be to join a pro-cure movement that is clearly succeeding despite their efforts.  Or, they can continue to publish their criticism.  Either way, stem cell therapy will flourish.

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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.

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.  

Stem Cell Therapy Can Cure Sickle Cell Disease

By A. Rahman Ford, PNN Columnist

Sickle cell disease is a debilitating illness that affects the hemoglobin in red blood cells.  The disorder causes the normally-round hemoglobin molecules to adopt an abnormal crescent or sickle shape. As a result, the patient suffers from anemia, repeated infections and periodic episodes of pain. 

According to the National Institutes of Health, sickle cell disease affects millions of people worldwide and is the most commonly inherited disorder in the U.S.  It affects approximately 70,000 – 80,000 Americans.  Blacks and Latinos are hit especially hard, with 1 in 500 and 1 in 1,000 being affected, respectively.

Pain is a major symptom of sickle cell disorder.  According to the Mayo Clinic, the pain develops when the sickle-shaped red blood cells block blood flow to the tiny blood vessels in your chest, abdomen and joints.  Pain in the bones can also occur.  Pain crises may last from hours to weeks and may require hospitalization.  According to mainstream medicine, there is no cure.  The only option is symptom management.

However, stem cell therapy (SCT) has brought new hope. Recently, it was reported that 11-year-old Valeria Vargas-Olmedo was cured of painful sickle cell disease.

That’s right. Cured.

In its first stem cell transplant for sickle cell disease, doctors at Loma Linda Children’s University Hospital in California used a stem cell transplant from Valeria’s father to cure the disease. This is noteworthy because the genetic match was only half – what is called haploidentical transplant. 

VALERIA VARGAS-OLMEDO AND HER PARENTS

VALERIA VARGAS-OLMEDO AND HER PARENTS

Prior to treatment, Valeria could not walk, go to school and experienced debilitating chronic pain. After conditioning with chemotherapy, the father’s cells were transfused directly into his daughter. After the treatment, Dr. Akshat Jain pronounced young Valeria “disease free.” 

The University of Illinois Hospital also offers SCT for sickle cell disease.  Using cells from a healthy, tissue-matched full sibling, patients receive immunosuppressive drugs and very low dose radiation before being infused with the cells. This method is less harsh and has fewer side effects than chemotherapy. The donor blood cells produce healthy new blood cells in the patient, eliminating symptoms and making the disease undetectable. 

In 2011, Iesha Thomas was the first patient to receive SCT for sickle cell disease at UI Health.  Six months later, she was cured.

Brothers Julius and Desmond Means were cured the following year.  In this video, Julius says having sickle cell disease as a young child was “like being tortured from the inside out.”


Saint Louis Children’s Hospital offers a similar therapy and uses cells from bone marrow, circulating blood or donated umbilical cord blood.

Unfortunately, not every hospital offers SCT for sickle cell disease.  However, if you are suffering from the illness it might be a good idea to contact a hospital that does, make an appointment with an experienced physician, and see what your options are. 

It is extraordinarily rare that mainstream medicine uses the term “cure” in association with any chronic disease.  Stem cell therapy has ushered in a new cure-based paradigm of medicine.  We need to take advantage of it.

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.