Despite FDA crackdown, stem cell therapy still ‘wild west’

Roper said a nurse had him lean over a table. Though the clinic’s website says it injects umbilical cord stem cells “directly into the painful area,” Roper said the nurse inserted the needle into his buttocks muscle, which medical experts say would have little or no effect on back pain.

Such can be the hazards of opening your wallet for stem cell therapy.

The technology is widely accepted for treating some blood disorders such as leukemia and for rebuilding tissues in burn victims, and it shows promise for easing joint pain and reversing the effects of multiple sclerosis, among other potential uses. But the budding science is also seized upon by opportunists short on clinical research but long on promises.

Bound to a wheelchair? Stem cell therapy could have the power to regenerate damaged tissues, ads portray. Getting older? Stem cell treatment can regrow hair, restore virility in the bedroom or ease aching joints.

It’s largely left to patients to sort out the dubious from the credible and recognize the risks. Many of the stem cell therapies on the market remain in the realm of the experimental, with safety and effectiveness still unproven. For a single treatment, patients may have to pay $3,000, or $10,000, or more, since insurance usually doesn’t cover it.

Federal regulators largely sat on the sidelines for decades, as doctors and cellular biologists have been studying the healing capabilities of stem cells cultivated from a patient’s own blood or fat tissue, or from donated amniotic fluid or umbilical cord blood.

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Then, after years of inaction from the Food and Drug Administration, last year President Trump's FDA commissioner announced a crackdown on "unscrupulous providers who prey on the hope of patients," seizing unapproved products from a California biotech company and sending warning letters to a Florida clinic and a New Jersey firm. A statement from the agency said it "will be stepping up our enforcement efforts — particularly going after products that pose a potential significant safety concern."

FDA also said that clinics need a special license if they take liposuctioned fat from a patient to produce stem cells, treat it with enzymes, and then inject it back into the body to treat a range of conditions. Such injections are now considered investigational new drugs.

A review of the local market by The Atlanta Journal-Constitution found some clinics pushing the same kinds of claims that the FDA criticized last year. At least one clinic appears to advertise treatment that may contradict FDA rules on stem cells derived from umbilical tissue. Still others offering experimental treatments may not have submitted FDA-required investigational new drug applications.

The AJC found no indication that the Georgia Composite Medical Board has ever taken action on any physicians for pushing unproven claims about stem cell therapy, nor has the Federal Trade Commission, which can sanction companies for deceptive advertising, intervened.

Patricia Zettler, an associate professor at Georgia State University law school and a former FDA staff attorney, said regulators may be hoping that well-publicized warning letters from the FDA will deter other clinics.

“It’s a little challenging in this area because there have been so many years in which the market has developed without FDA oversight,” Zettler said. “And so it’s tougher to rein in a market that already exists, than to prevent one from developing.”

Eyesight to the blind

Meanwhile, a lawsuit filed by a Florida woman in Fulton County State Court last month says that a stem cell treatment left her totally blind.

Doris Tyler, 77, from the Orlando area, is suing a stem cell clinic in Peachtree City, alleging she paid $8,900 for treatment of age-related macular degeneration. While Tyler's vision was failing and she was legally blind, she could still see well enough to cook, read and play the piano.

But the eye disease is considered incurable, and experimental stem cell treatments by Japanese researchers have shown promise for halting the effects. By having the procedure, Tyler thought she was part of a research study, though her suit claims the clinic was not part of any legitimate study.

The procedure by physician Jamie Walraven of Stem Cell Center of Georgia and Atlanta retinal surgeon Robert Halpern involved drawing fat tissue from Tyler's abdomen by liposuction, spinning it in a centrifuge to extract and isolate stem cells, then injecting the material by needle into each of her eyeballs, according to the complaint.

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Instead of treating one eye at a time to make sure the treatment was safe, her eyes were injected a day apart, the lawsuit says. Within months, both her retinas separated from the layer underneath, requiring several surgeries. Tyler soon lost her vision completely.

One of Tyler’s attorneys, Andrew Yaffa, represents three other women who are suing stem cell clinics in Florida, alleging similar treatments left them blind.

Walraven did not return calls from the newspaper last week and Halpern said he couldn't comment on ongoing litigation. They have not responded to the lawsuit, as an answer is not yet due.

Stem Cell Center of Georgia's website still lists macular degeneration as one of many ailments that can be treated with stem cells, along with multiple sclerosis, Parkinson's, stroke, cardiac disease, erectile dysfunction, male incontinence and hair loss.

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True believers

Another of Dr. Walraven’s patients, Kathy Doswell, considers herself a satisfied customer.

Doswell, from Snellville, has been diagnosed with multiple sclerosis since 1999. She has had two stem cell treatments since 2014, both by extracting fat tissue by liposuction and injecting stem cells into her bloodstream. Each treatment cost about $9,000, she said, which she raised with a GoFundMe page and by taking out a loan.

She said she received her second treatment at Walraven’s office. Doswell said she’s considering a third.

“Out of all the different things that I have tried, it is the only thing that helped me,” Doswell said. “Just generally speaking, it was more energy, more flexibility … I could tell my legs to move, and they would. Whereas before, there was no activity from the brain to the legs.”

She still uses a wheelchair, though. Doswell said the biggest drawback is that the effects fade after about six to nine months, requiring a booster.

In written answers to questions from the AJC, the FDA said using fat stem cells to treat neurological disorders such as MS is not FDA-approved and would require submission of an investigational new drug application. The AJC could not confirm if Stem Cell Center of Georgia has submitted one.

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Alan Hause, another MS patient, said he has seen more dramatic results. Last year he traveled to India and paid $30,000 for a procedure known as hematopoietic stem cell transplant, which uses chemotherapy and blood-forming stem cells. The procedure involved using chemo drugs to destroy his immune system, drawing blood from his neck, then injecting stem cells intravenously.

Hause, who lives in Jonesboro, can now go to church and to Braves games without his wheelchair. At home, he can walk down the stairs from his front door to the sidewalk, barely holding the rails.

“Before I left, I was dependent on a wheelchair or what’s called a Rollator, like a walker,” he said. “I couldn’t walk on my own. When I returned, I was able to walk with a cane. That’s the biggest improvement I’ve seen.”

Dr. James Bowen, medical director of the Multiple Sclerosis Center at the Swedish Neuroscience Institute in Seattle, doesn't doubt his story.

“We think this is legit,” Bowen said of hematopoietic stem cell transplant treatment. “Our studies show, five years after the treatment, that it was just shy of 70 percent of people were completely stable on their MS, which is remarkable.”

However, he’s skeptical about using fat tissue to treat MS, as Doswell described. No solid studies back that up, he said.

Changing definitions

When the FDA announced it would step up enforcement on stem cell clinics last year, it also acknowledged that some therapies show promise, pledging to make legitimate research easier.

Still, it remains unclear how far doctors can go without submitting investigational new drug applications to the FDA, which lay out plans for clinical trials on humans, and what treatments clinics can legally advertise to the public.

The AJC found Atlanta-area physicians offering stem cell treatment without FDA approval. Clinic doctors have long argued that if they’re only transplanting stem cells from one part of a patient’s body to another, that’s not a drug and the FDA cannot regulate it.

But if the cells are significantly manipulated through processing, mixed with other drugs or moved to another part of the body to serve a different purpose, the FDA says it does have purview.

The agency also has asserted authority over the use of amniotic or umbilical stem cells, since the tissue comes from another person. The FDA says such products are only exempt from regulation if they don’t rely on living cells for their therapeutic effect — which would make “stem cell therapy” false advertising — or if the tissue is used on a blood relative of the donor mother/baby.

Stem Cell of Atlanta says it uses a product derived from umbilical tissue to treat hip, knee, shoulder and joint pain. After the feds reiterated their tissue guidelines last year, the company's website changed from saying it offers "stem cell therapy" to saying it offers "regenerative cell therapy."

Asked how this material can be used on non-relatives, CEO Ross Carter, a chiropractor, characterized the injections as allografts — tissue transplants from a willing donor to a willing recipient. Growth factors and proteins in the material stimulate healing, he said.

“It does contain stem cells, but we can’t call that stem cell therapy because that would violate the FDA guidelines,” Carter said. He also offers injections using patients’ bone marrow, which he does call stem cell therapy.

All procedures are overseen by doctors, Carter said. Under Georgia law, chiropractors cannot do the injections.

Superior Healthcare Group, the Atlanta/Ohio chain of clinics where Loy Roper says he received a buttocks injection for back pain, still advertises umbilical stem cell therapy as "one of the newest and most cutting-edge therapies for chronic joint pain."

Steven Peyroux, a chiropractor who runs the clinic in Canton, scheduled a phone interview with the AJC, but didn’t answer when a reporter called. He gave limited answers to questions by email. Asked if he’s taking part in any FDA trials, Peyroux said, “The FDA only controls the tissue labs and the safety of their products for now. There are proposal guidelines that have not been adopted into law as of yet.”

As to Roper’s account, Peyroux said, “I can tell you we don’t inject stem cells in the buttocks.”

Medical records from the clinic say Roper’s amniotic injection went into his lower back. But he insists that’s not correct, that the needle went into his gluteus maximus muscle.

After that, Roper said, the clinic had him come back for twice-a-week follow-up therapy, which amounted to chiropractic adjustments of his back and neck. He quit those after six months, when his pain management doctor, P. Tennent Slack, told him stem cells injected into his backside would be unlikely to affect his degenerated spine.

Slack later gave him blood and amniotic injections into the joints and nerves of his spine. The doctor said he’s been using regenerative cell therapy for about five years — but only in limited circumstances, and typically only when procedures covered by insurance won’t work.

But most stem cell therapy is still new territory for doctors, and how the treatment works on a molecular level remains unclear, he said. “Unfortunately,” the doctor said, “there’s a certain amount of wild west that is going to go on.”