By Pat Anson, Editor
The testimonials sound so encouraging. Chronic pain from arthritis, neuropathy and degenerative disc disease begins to fade after a single injection of stem cells.
“The next day after a needle went in there, the next morning they felt better. Immediately,” says 93-year old Curtis Larson, who suffered from neuropathic pain in his feet and ankles for nearly a decade.
"Pain’s all gone. Completely gone,” Larson says in a promotional video hosted on the website of Nervana Stem Cell Centers of Sacramento, California.
“You don’t have to accept chronic joint pain as a fact of life. There’s still hope even if medications and other treatments haven’t worked for you. Our practitioners can explain to you how stem cell treatments work and whether you can benefit,” the Nervana website states. “Relief may be on its way!”
We’ve written before about experimental stem cell therapy and how injections of cells harvested from a patient’s bone marrow or blood are being used to treat chronic conditions such as low back pain.
Professional athletes such as Kobe Bryant and Peyton Manning have used one stem cell treatment – known as platelet rich plasma therapy -- to recover from nagging injuries and revitalize their careers.
But has stem cell therapy moved beyond the experimental stage? Is it ready for widespread use?
“Published data derived primarily from small, uncontrolled trials plus a few well-controlled, randomized trials have not reliably demonstrated the effectiveness of stem-cell treatments,” wrote FDA commissioner Robert Califf, MD, in a commentary recently published in the New England Journal of Medicine – an article clearly aimed at throwing cold water on some of the hype surrounding stem cell treatment.
Califf and two co-authors said there is simply not enough evidence to support some of the newer stem cell therapies – such as cells harvested from a patient’s body fat (adipose tissue).
“The safety and efficacy of the use of stem cells derived from peripheral blood or bone marrow for hematopoietic reconstitution are well established. Increasingly, however, hematopoietic stem cells and stem cells derived from sources such as adipose tissue are being used to treat multiple orthopedic, neurologic, and other diseases. Often, these cells are being used in practice on the basis of minimal clinical evidence of safety or efficacy, sometimes with the claim that they constitute revolutionary treatments for various conditions,” they wrote.
But the lack of evidence and FDA approval haven’t stopped stem cell clinics from popping up all over the country. Over 570 such clinics now operate nationwide, with over a hundred of them in California alone, according to the Sacramento Bee. Some clinics – such as Nervana Stem Cells – are hosting free seminars for chronic pain patients, publicizing them with advertisements that read, “We want you to start living your life pain free!”
A Sacramento Bee reporter attended one seminar and listened to a former chiropractor who works for Nervana tell the audience that they can lower their pain scores from 8’s and 9’s to “mostly 0’s and 1’s” after 16 weeks of injections. He said the clinic has a 90 percent success rate.
Nervana does not use stems cells derived from bone marrow, blood or body fat, but uses a solution of embryonic stem cells from the “after-birth of healthy babies,” the Bee reported. Costs ranged from $5,000 for a single joint injection to $6,000 for a spinal injection. Stem cell therapy is not usually covered by insurance.
“It’s quite clear that these people are offering treatments that haven’t been tested in clinical trials. It’s a little concerning,” Kevin McCormack, a spokesman for the California Institute of Regenerative Medicine told the Bee.
“There’s a gray zone where these clinics are operating,” he said. “The FDA needs to address the issue of these clinics and address this slow, onerous approval process for stem cell therapy.”
The FDA’s Califf says the agency is not trying to stifle research into a promising new field of medicine -- it’s just waiting for proof that the treatments work and don’t cause harmful side effects. He cited cases in which stem cell patients developed tumors or went blind after injections.
“Such adverse effects are probably more common than is appreciated, because there is no reporting requirement when these therapies are administered outside clinical investigations,” Califf wrote. “The occurrence of adverse events highlights the need to conduct controlled clinical studies to determine whether these and allogeneic cellular therapies are safe and effective for their intended uses. Without such studies, we will not be able ascertain whether the clinical benefits of such therapies outweigh any potential harms.”