Health & Fitness

Stem cell industry ‘fleecing,’ sometimes harming patients

Retired University of Missouri-Kansas City professor Elizabeth Noble traveled to Florida for stem cell injections to try to halt vision loss. Instead, she went blind, according to a lawsuit she filed. The Food and Drug Administration recently won a court case banning the clinic Noble went to from providing unapproved treatments.
Retired University of Missouri-Kansas City professor Elizabeth Noble traveled to Florida for stem cell injections to try to halt vision loss. Instead, she went blind, according to a lawsuit she filed. The Food and Drug Administration recently won a court case banning the clinic Noble went to from providing unapproved treatments. UMKC Foundation via Kansas City Star

Elizabeth Noble flew from Kansas City, Missouri, to Florida in 2015 looking for a miracle cure for the macular degeneration that was slowly robbing her of sight.

Instead, she became an early cautionary tale about the dangers of a largely unregulated stem cell industry that has since expanded all over the United States.

Noble, a retired University of Missouri-Kansas City professor, was 72 when she traveled to the U.S. Stem Cell Clinic in Sunrise.

According to court records and medical case studies, she had 20/60 vision in her right eye and 20/30 in her left when she entered the clinic: worse than normal, but certainly not debilitating.

She paid $5,000 for clinic staff to withdraw fat from her abdomen, extract stem cells from it and then inject a mixture of the cells and her blood plasma into both eyes.

Three days later, Noble showed up at the University of Miami’s Bascom Palmer Eye Institute, with severe pressure and bleeding in her eyes. Doctors there did what they could to help, but her retinas were badly damaged. In the months that followed, both retinas would atrophy and one would detach, leaving her unable to see any light in either eye. She was legally and functionally blind, suffering “bodily injury, pain and suffering, disability [and] disfigurement,” according to a lawsuit she filed.

Years later, after several more complaints, the Food and Drug Administration took U.S. Stem Cell to court and forced the company to stop its eye injections. But by then the for-profit stem cell industry had spread like a virus, despite warnings from medical researchers and bioethics experts that the clinics are peddling unproven, sometimes dangerous treatments for things including mild arthritis, erectile dysfunction, multiple sclerosis and Parkinson’s disease.

“The companies are making a killing off of all of us that have creaky knees and bad elbows and throwing injuries,” said Christopher Scott, a medical ethics expert at the Baylor College of Medicine who has studied the for-profit stem cell industry. “They are basically fleecing people for thousands of dollars for these interventions that simply don’t work. And they do it because they can.”

By some estimates, 1,000 clinics in the United States now offer stem cell treatments that haven’t been vetted and approved by the FDA.

Clinics extract cells from patients’ fat and bone marrow or get them from tissue banks that traffic in donated umbilical cord blood or amniotic fluid and then inject them into knees, shoulders and backs or infuse them intravenously.

Clinic owners said they’re offering a valuable alternative to surgery and opioids. They say they have helped hundreds of people and have the patient testimonials to prove it.

But researchers say that without controlled studies that compare those treatments to placebos, the testimonials are almost meaningless scientifically.

“At a core, medicine-science level, this stuff is not proven,” said Paul Knoepfler, a researcher from the University of California, Davis, who tracks the unregulated stem cell industry. “My view is that it shouldn’t be sold until they’re proven.”

Experts like Knoepfler and Scott say that at best the clinics are charging people thousands for treatments that may be no more effective than saltwater. At worst, they’re harming people. In addition to Noble, others who say they’ve been injured by stem cell treatments include:

▪ Two other women who say they were also blinded by U.S. Stem Cell, and a third who says she felt faint and started vomiting right after getting arthritis injections there.

▪ Several patients who say they suffered similar damage after getting eye injections at other clinics in Florida and Georgia.

▪ At least 17 people across five states hospitalized with serious infections caused by umbilical cord products contaminated with various organisms including E. coli, a bacterium found in feces.

Sunil Abhyankar, the director of the Midwest Stem Cell Therapy Center at the University of Kansas Medical Center, said unregulated clinics are threatening the credibility of the entire stem cell research field.

Stem cells show promise, Abhyankar said, and his institution is doing the slow, painstaking work of running clinical trials to figure out how to use them safely and effectively. But in the meantime, patients should be skeptical of clinics that charge them lots of money while promising miraculous effects for a wide range of conditions.

“There is a lot of research that needs to be done before we can claim that these cells are truly, you know, doing what we hope they can do,” Abhyankar said. “And this research has to be done within the context of the FDA framework for clinical trials.”

Abhyankar warned that although some stem cell clinics list their services on ClinicalTrials.gov, that does not mean they’re FDA-approved trials. Some of the procedures that allegedly caused eye injuries were among those listed on the government site, which has few restrictions on what is posted there. Critics say stem cell clinics “co-opt” the site “to market unproven therapies,” according to a June story on Stat, a health news website.

So far, the FDA hasn’t taken action against stem cell clinics in any comprehensive way, instead taking a few particularly bad actors to court while issuing an escalating series of warnings to the rest of the industry.

Agency leaders have promised more action is coming.

But Scott said they’ve let the industry grow too big, and now it will be difficult to rein it in.

“In my view,” Scott said, “the FDA has a bonfire on its hands.”

The victims

Noble’s Florida attorney, Andrew Yaffa, said because of a legal settlement she cannot talk about what happened to her beyond what’s in the public record.

But he said that since he started representing plaintiffs injured by U.S. Stem Cell, his phone has been ringing continually with people who say they have similar stories.

“I have represented five separate people and been contacted by dozens and dozens [more],” Yaffa said. “From across the United States. I’ve been contacted from Arizona, California, Atlanta, all over the state of Florida.”

Like Noble, Jeff Ariss wanted to try a stem cell treatment for macular degeneration, so he traveled from his home in Canada to Florida for a procedure of his own with two other Florida doctors, Steven Levy and Jeffrey Weiss.

Levy and Weiss have offices at the Healing Institute in Margate. The Parkcreek Surgery Center in Coconut Creek, an ambulatory surgical center where various doctors rent operating rooms, is where they did the actual stem cell extractions and injections.

Their eye treatment was listed on ClinicalTrials.gov, so Ariss thought it was legit. But the results were much the same as Noble’s.

When he woke up, all sorts of “floaters” obscured his vision, and it never got better, he said. One of his retinas detached, and he ended up legally blind.

“I was desperate,” Ariss said. “I’ve been going blind for 19 years now and it sucks. I jumped the gun and I obviously shouldn’t have, and this is where I ended up. He has no remorse whatsoever.”

Ariss said he paid the clinic $22,000 and then spent $40,000 to $50,000 at other medical centers trying in vain to fix the damage.

While the FDA eventually obtained an injunction to stop eyeball injections at U.S. Stem Cell, it has not taken legal action against Levy and Weiss or the Healing Institute.

He said he considered suing but found out Weiss wasn’t carrying malpractice insurance. That’s allowed in Florida and about 30 other states. Such doctors are liable for any injuries, but if they don’t have the money, plaintiffs have no guarantee of collecting on a settlement or judgment.

Weiss didn’t respond to a request for an interview. Levy offered only a brief response when reached by phone.

“We are a regulated study and frankly I have no comments,” Levy said. “We have not caused any patients to go blind.”

In a follow-up email, Levy and Weiss said they’ve treated about 600 people and the “overwhelming majority” are happy with the results. They said that the few patients complaining were already mostly blind and are just seeking money.

The pair have published a dozen papers about their stem cell injections, including some case studies citing significant vision improvements verified by doctors at the Johns Hopkins Wilmer Eye Institute and The Ohio State University.

One of those doctors, ophthalmologist Susan Benes, is no longer with Ohio State, a receptionist said. Benes didn’t respond to a message left at the Heart of the Rockies Regional Medical Center in Colorado, where she is now listed as a provider.

Optometrist Alexis Malkin was a part-time faculty member at Johns Hopkins when she co-authored a paper with Weiss and Levy. She is now a professor at New England College of Optometry. Reached via email, she said she didn’t participate in Weiss and Levy’s clinical trial but was one of the patient’s vision providers before and after the treatment. Malkin didn’t respond to follow-up requests for information about the patient’s results.

A research paper by four other eye doctors published in Retina Specialist magazine in February said at least 40 commercial stem cell companies offer eye treatments at 76 clinics across the country, despite little evidence they work.

“We found a paucity of publications supporting these treatments: no level 1, 2, 3 or 4 evidence,” the authors wrote, referencing a scale of evidence-based medicine developed by the University of Oxford.

Tom Harris of Texas was only in his 50s when he got injections from Levy.

“Ended up being the worst decision I ever made in my life,” Harris said.

He said his vision was about 20/60 before the procedure, and he’s now blind in one eye and “severely impaired” in the other. He said his vision loss cost him an executive-level job with an aerospace engineering company that paid six figures. He’s now living off his savings.

“Once they got your money and once they’re done with your surgery, they don’t talk to you,” Harris said. “They don’t want to see you, they don’t want to hear from you. Nothing.”

About 100 miles down the road from Harris lives Timothy Lunceford, who was hospitalized for almost two months last year after getting a stem cell injection for back pain at a clinic in Texas.

“It felt like someone stuck a knife into the middle of my back and just left it there,” Lunceford, a 52-year-old wildlife biologist, told the Washington Post in February.

Lunceford filed a lawsuit, which ended in a settlement. It describes him developing a life-threatening infection, spending weeks wracked with pain and needing back surgery in which a neurosurgeon carefully excised infected tissue from around his spine.

Doctors found E. coli and one other type of bacteria in his back.

Lunceford’s was one of 12 hospitalizations that the Centers for Disease Control linked to products sold by Liveyon, a California-based distributor of stem cells from umbilical cord blood.

The victims, spread across Texas, Florida and Arizona, had injections in their knees, shoulders and backs at orthopedic centers and pain clinics. A few also had IV infusions.

Lunceford’s infection was probably the most serious, but other patients were hospitalized for 35, 30 and 15 days.

“It was awful,” said Harley Hampton, a Texas attorney who represented six of the victims. “These people had fevers in the 104, 105 (degree) range. They were delusional, hallucinating, had to be life-flighted to bigger facilities for a higher level of care. It’s a miracle that there aren’t some deaths.”

Liveyon officials have blamed the contamination on one of their suppliers, Genetech, and said they’re no longer buying umbilical cord tissue from that company.

But critics like Knoepfler have said that Liveyon’s sales pitch still seems more centered on making money than helping patients.

The FDA

The FDA has been signaling for years that it’s getting ready to take a harder line on stem cell clinics.

The agency allows stem cells to be extracted and then re-injected into the same patient as long as the cells are only “minimally manipulated” in between. The thinking is that the government can’t regulate how a person uses his or her own tissue. But if the cells are processed in any way after they’re removed, they can be considered drugs subject to FDA approval.

It’s become clear in recent years that as the industry has grown, many clinics are going far beyond what the agency intended to allow.

“Some actors are leveraging the widespread belief in the eventual promise of these products, flouting the statutes and our regulations, and deceiving patients by illegally manufacturing or selling purported therapies, and falsely promoting their benefits,” then-FDA commissioner Scott Gottlieb said just before he left the job in April.

The case of U.S. Stem Cell — where Elizabeth Noble said she was blinded — shows that the FDA can force clinics to stop offering dangerous treatments. But it’s not easy.

The agency, through the U.S. Justice Department, sued the company in May 2018, several years after the first complaints of patients going blind. U.S. Stem Cell had fought attempts to regulate it to that point and continued to fight them in court.

But in June 2019, a federal judge ruled in the FDA’s favor, granting a permanent injunction banning the company from performing further unapproved stem cell treatments.

“In the case against U.S. Stem Cell Clinic, the clinic and its leadership have put patients at serious risk through their disregard of the law and prior FDA warnings,” FDA official Peter Marks said after the verdict. “This decision today is a victory for the FDA’s work to stop these bad actors and to protect patients.”

In another June statement released by Marks and Gottlieb’s replacement, Ned Sharpless, the FDA said it’s well aware that clinics across the country are marketing unregulated stem cell treatments to the public and claiming those treatments don’t fall under the FDA’s rules for drug and biological product testing.

“The FDA has consistently stated that this is not true, and the result of this case proves that,” the statement said, referencing the U.S. Stem Cell decision. “There are many examples of companies deceiving patients with unsubstantiated claims about the potential for stem cell products to prevent, treat or cure serious diseases, and in those cases, we are committed to acting to protect patients.

“These actors are taking advantage of patients, many in vulnerable positions with chronic or terminal diseases. … This ultimately puts at risk the very patients that they claim to want to help, by either delaying treatment with legitimate and scientifically sound treatment or, worse, posing harm to patients, such as blindness, infection or possibly death.”

The agency officials said they are committed to “aggressive oversight, prioritizing resources to address those clinics, individuals and products that put patients most at risk.” They cited 46 warning letters to operators in the stem cell industry and an ongoing court case against Mark Berman, a Beverly Hills doctor the agency sued after federal agents raided his lab in 2017. The agents seized five vials of live smallpox vaccine — a restricted substance — that Berman was combining with stem cells and injecting into cancer patients.

But the agency is now in a high-stakes game of whack-a-mole. More clinics are opening every month, joining the hundreds already in operation, including some accused of harming people.

“If a thug walked up to me on the street and stabbed me in the eye with a knife he would get charged with assault and thrown in jail, right?” Ariss said from his home in Canada. “What is the difference between that thug and what Weiss did to me? Just because he’s a doctor he’s still getting away with it.”

Are you considering stem cell treatments?

The Food and Drug Administration recommends first asking clinics if the FDA has reviewed how they’re using stem cells. If they say they’ve been reviewed, ask the clinic for its FDA-issued Investigational New Drug Application number and have your personal doctor review the information.

If you have been harmed by stem cell treatments and want to tell us about it, email amarso@kcstar.com.

Andy Marso: 816-234-4055, @andymarso

Stem cells and the placebo effect

Stem cells are the raw material of human tissue, able to develop into many other cell types. They’re derived from bone marrow and umbilical cord or amniotic tissue and have been approved for treating a small set of illnesses: certain types of cancers and blood disorders.

Most stem cell clinics are using them “off-label,” meaning for uses other than what they were tested for.

Experts say there’s not enough evidence that those cells, or the fat cells other clinics are using, can effectively treat the myriad illnesses they’re now being marketed for.

Some studies show promise for treating arthritis with adult stem cells, but most of the trials have been extremely small, many have no placebo group and few had any long-term follow-up to see if the self-reported benefits of treatment last.

A 2017 analysis of multiple studies showed that 80% of people reported improvement in their knee pain after getting injections of normal saline — nothing more than saltwater.

The University of Missouri Health Care’s BioJoint Center in Columbia uses stem cells from bone marrow for only one purpose: to promote healing when donor bone is grafted onto a patient’s bone. But the center does not recommend using stem cells “for injections into joints, tendons, ligaments, meniscus, or muscle for any purpose.

“The current scientific studies do not provide sufficient evidence for the efficacy of stem cells for these purposes,” the center’s website says, “and there are some significant risks as well.”

The evidence that stem cells can treat other conditions is even more preliminary.

Take multiple sclerosis. The MS Society says that although stem cell research has “generated a great deal of interest and holds promise, the field is in its infancy and much more research is needed before cell based therapies become a MS treatment option.”

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