By Gina Kolata, New York Times

Health regulators in the United States are talked about as the best in the world, but a new study on the spread of stem cell clinics shows what can happen when regulations fall behind.

Out of nowhere, over the last two to three years, clinics have sprung up — 570 in the United States, according to a recent paper — offering untested stem cell treatments for just about every medical use imaginable.

In theory, stem cells might be a useful treatment for certain diseases that involve the loss of cells, like Type 1 diabetes, Parkinson’s or osteoarthritis. They are primitive cells that can develop into a range of mature cells and perhaps serve as replacements. But progress is slow. After a flurry of stem cell excitement two decades ago, almost all the research today is still in mice or petri dishes. The very few clinical trials underway are still in the earliest phase.

The problem is that stem cell therapies are still mostly theory. So what is going on? How can there be clinics, even chains of clinics run by companies, offering stem cell treatment for almost any disease you can think of — sports injuries, arthritis, autism, cerebral palsy, stroke, muscular dystrophy, ALS, cancer?

An orthopedic clinic, for example, says on its website, “Stem cells actually restore degenerated tissue while providing pain relief.” Another clinic seeks patients with neurological diseases, asserting, “The regenerative nature of the fatty adult stem cells that are extracted from the patient can help improve the degeneration and ease the symptoms associated with the disease.”

The rapid proliferation of stem cell clinics “looks like it is occurring on a nationwide industrial scale,” said Leigh Turner, a bioethicist at the University of Minnesota, who, with Paul S. Knoepfler, a stem cell researcher at the School of Medicine of the University of California, Davis, published the new paper tallying the clinics. “It’s operating brazenly, out in the open. It leaps out of these cultural assumptions about hopes and dreams of stem cell treatment, but there is no science behind it.”

The Food and Drug Administration allows clinics to inject patients with their own stem cells as long as the cells, or the tissue the cells are extracted from, meet specific criteria, including “minimal manipulation,” and are intended to perform their normal basic function.

But even if treatments the clinics advertise seem questionable, the FDA cannot act based on a website. “They have to have actual cases of clinics administering the cells to patients,” said Ubaka Ogbogu, an assistant professor of law at the University of Alberta in Canada who has studied the clinics and their regulation. “These clinics are being run by very sophisticated people. They understand the laws very well and have been working around the laws.”

Some clinics advertise treatments that seem to flout the regulations, offering, for example, stem cells from amniotic fluid, which do not qualify under the FDA’s rules because they are not from the patient’s body. Others advertise stem cells collected from a person’s blood or fat to treat a neurological disease like Parkinson’s disease or multiple sclerosis. Those cells do not qualify because they do not normally function in the brain to control movement. There is no registry of patients going to these clinics, so it is unclear how many have been treated.

Outraged, Knoepfler has confronted some of the clinics.

“I have spoken to the clinics and they say, ‘OK, you have lectured me about FDA regulations, but I have been doing this for years and never heard a peep from the FDA.’ They see it as a tacit green light,” Knoepfler said.

On their websites, the clinics promote anecdotes and videos of happy patients. One clinic that uses stem cells to treat neurological diseases has a video of a patient, Barbara, and her husband on its website. She says she has multiple sclerosis and reports marked improvements after stem cell treatments, like driving again for the first time in years. “I feel so blessed that I have gotten better from the procedure,” she says.

Professional medical societies and state licensing boards should crack down, says Insoo Hyun, an ethicist at Case Western Reserve University and past ethics chairman for the International Society for Stem Cell Research (ISSCR). After all, he said, the stem cell clinics employ doctors, and doctors have a duty to offer patients evidence-based medicine.

But academic scientists feel stymied.

Dr. George Q. Daley, a stem cell researcher at Harvard Medical School and a past president of the stem cell research society, explained that the group had “spoken fairly aggressively about the false claims, but we have no enforcement power.” The group has its own website, A Closer Look at Stem Cells, that tries to caution patients, but Daley acknowledges it is no match for the clinic websites.

“The problem is a bit like the Whac-a-Mole game,” he said.

Some scientists want to counter the clinics by fighting anecdotes with anecdotes.

Anecdotes are powerful. Journalists use them constantly — nearly every story about a study of a new drug or treatment includes the obligatory patient, often with a photograph. Medical centers use them routinely in advertising — the grinning cancer patient praising a cutting-edge treatment, the person with a knee replacement crowing about how wonderful life is without constant pain. Not the sort of evidence that would persuade a scientist, but memorable in the way a study’s findings may not be.

The problem is that patients who have had bad experiences and even those who, while not harmed, spend tens of thousands of dollars to no avail rarely report back to academic scientists. And when they do, researchers say, they tend to shy away from publicity for a variety of reasons — embarrassment, nondisclosure agreements that some signed to get the stem cells, a fear of litigation and just a reluctance to discuss their medical decisions, Knoepfler said.

Knoepfler says he hears from more patients than most because he writes a blog, but patients almost always deny him permission to blog about what happened to them using their names.

One man who contacted him recently had gone to a stem cell clinic for treatment of his arthritis. In the man’s opinion, the clinic had missed his joint when they injected the cells. He needed other medical treatments to alleviate the pain, and he said he was worse off than before he had the treatment. And yes, he said, he wanted Knoepfler to tell his story.

“I felt obligated to let him know the clinics could threaten litigation,” Knoepfler said, explaining that clinics have made such threats against him and his colleagues. “It was my sense that a patient who discusses serious concerns about a clinic could be threatened by them, too,” he said. The man changed his mind about going public.

“It’s an unequal playing field,” said Timothy Caulfield, a professor in the school of law and public health at the University of Alberta. “Stem cell clinics are untethered from the science and can use whatever kind of story they think will market their product the best.”

But Arthur Caplan, head of the division of bioethics at New York University Langone Medical Center, opposes countering rosy anecdotes with grim ones. Like most academics, he is wary about patient stories, pro or con. He has heard tales of patients waking up from brain death, for example, when they never were in that state in the first place. Or, he says, “there are causation problems — X gave me a seizure when the seizure was going to happen anyway.”

Stories of poor outcomes may not help anyway, he says, because patients who are looking for hope will seize on stories of cures or improvement and disregard stories of failure.

The argument that anecdotes from scientists will not help does not sway Ruth Gass, whose brother-in-law Jim Gass had a disastrous experience at a stem cell clinic in Mexico. Seeking treatment for a stroke, he ended up with a growing mass of cells in his spine that paralyzed him from the neck down, save for the use of his right arm.

She wrote in an email: “Jim’s life has been tragically and unnecessarily destroyed, and the question is not whether to use stories like Jim’s but how to most effectively use such stories and how to find more such sobering ones. I can’t think of any reason why scientists would not use these cautionary stories that contradict the dishonest/distorted/unproven ones.”

The FDA has issued drafts of guidance documents that it says are meant to help clinics comply with its regulations. It is holding a meeting this fall to discuss them.

Critics are hopeful that, if nothing else, the result will be more oversight by the FDA and more enforcement actions that they say are long overdue.

To Learn More:

Stem Cell Blood Bank Settles after Losing Personal Data of 298,000 Clients (by Ken Broder, AllGov California)

FDA Clears First Test of Human Embryonic Stem Cell Therapy (by David Wallechinsky)