Will Green, a retired Sacramento psychiatrist, was desperate for relief from painful fibromyalgia and neuropathy in his feet. Having spent thousands of dollars on prescription medications, massage and acupuncture that failed to ease his pain, Green turned to the hottest alternative remedy in medicine today: stem cells.
On Halloween, he walked into Nervana Stem Cell Center in Fair Oaks and received two injections, one in each ankle. More than three weeks later, Green, 67, says he’s seen 60 percent improvement in the tingling and numbness that had made walking or climbing stairs difficult.
“It’s working for me,” he said, “and I’m looking forward to even more improvement.”
For long-suffering patients such as Green, stem cells offer tantalizing hope. In the last few years, more than 570 stem cell clinics have popped up nationwide, advertising treatment for a range of maladies, from autism and Alzheimer’s to neuropathy and Parkinson’s disease, according to a recent UC Davis study. About 113 of those are operating in California.
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But do they really work? According to most stem cell experts and the federal government, there’s no way to know yet.
That’s not much solace for consumers, who are clamoring for answers while being bombarded by enticing ads and testimonials that stem cells can cure their afflictions
“It’s quite clear that these people are offering treatments that haven’t been tested in clinical trials. It’s a little concerning,” said Kevin McCormack, spokesman for the California Institute of Regenerative Medicine, which has provided about $2 billion in public money for stem cell research since 2006.
“It may not actually harm anyone. … But the big concern is that they’re giving you something that’s not proven and you’re spending a lot of money.”
McCormack said he fields calls and emails daily from people in California and across the globe, asking whether the stem cell treatment they’re considering is worth it.
Stem cell injections are expensive – often $5,000 to $6,000 each – and not covered by insurance. And almost none have approval from the U.S. Food and Drug Administration, which oversees stem cell regulations.
“The value of stem cells as a treatment for most conditions is largely unproven and more information is needed about their potential benefits,” said FDA spokeswoman Andrea Fischer via email. “The FDA is concerned that the hope patients have for treatments not yet proven to be safe and effective may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.”
On its website, the FDA warns that, while cell-based therapies are promising, there is also reason for concern: “Cells manufactured in large quantities outside their natural environment in the human body can become ineffective or dangerous and produce significant adverse effects, such as tumors, severe immune reactions, or growth of unwanted tissue.”
“My view is that it’s a giant human experiment that doesn’t have FDA approval,” said Paul Knoepfler, a UC Davis stem cell expert, who co-authored the study identifying the 570 clinics. “I don’t know how much patients are aware of how uncertain the benefits and risks are. As a scientist, it’s worrisome.”
Until the FDA finalizes its guidelines, consumers are largely left to figure it out alone.
In recent months, Nervana Stem Cell Centers has invited consumers to free seminars at hotels in Roseville, Rancho Cordova, Napa and Yountville. “Neuropathy Stem Cells are Providing HOPE,” some of the advertisements read. “We want you to start living your life pain free!”
On a rainy morning in late October, about 25 people sat in a small hotel conference room in Rancho Cordova as Kristofer Chaffin, a former Sacramento chiropractor who works for Nervana, delivered an hourlong presentation on the benefits of stem cells to treat joint pain and neuropathy. “I sold my (chiropractic) practice for the same reason all of you are here today: stem cells,” Chaffin told the room. “This is where the future of medicine is.”
Chaffin showed photos of his baby daughter with Tyreke Evans, who he said was one of his former Sacramento Kings clients. He shared positive Nervana testimonials from people such as NFL free agent Marlon Moore and a 93-year-old patient. He touted the credentials of Nervana’s founder, Dr. Tushar Goradia, a Harvard-trained doctor who holds a Ph.D. in applied mathematics.
Chaffin favorably compared the benefits of stem cell therapy with the risks of surgery, cortisone shots and prescription drugs. And to a roomful of people dealing with chronic pain, he put up charts saying that 16 weeks after injections, most patients reported their pain levels had dropped from highs of 8s and 9s to lows of “mostly 0s and 1s.”
Afterward, some in the audience eagerly signed up, taking advantage of the “Today Only” discount. Instead of the regular $6,495 per-injection fee, the Nervana seminar price was $4,995 for a single joint injection or $5,995 for a spinal. One of those booking an appointment was Green, who said he was “quite skeptical” before he showed up, but was persuaded in part by Nervana’s claims of a “90 percent “ success rate in relieving chronic pain symptoms.
Others weren’t sold. “I wanted more science, rather than a lot of blue-sky testimonials and graphic photos of before-and-after results,” said Orangevale resident Tom Kleeh, who attended with his wife, Nancy, who has tendinitis. Even with a discount, the price sounded too high.
Repeated calls and emails to Chaffin and Dr. Goradia to discuss follow-up questions about the seminar were not returned.
On its website, the Fair Oaks-based company, which also runs a clinic in San Diego, states: “While we are very hopeful about the clinical future of stem cells, the use of stem cells is not FDA approved for the treatment of any specific condition, and their (use) may be considered investigational.”
At the seminar, Chaffin said Nervana does not use bone marrow, fat or embryonic stem cells, but uses a solution of newborn fetal stem cells from the “after-birth of healthy babies” that are frozen and sold by FDA-approved labs.
“Is it legal, ethical or even effective? Is it worth $5,000? The public needs to know what they’re getting,” said Dr. Marko Bodor, an interventional spine and sports medicine specialist in Napa, who said he attended one of Nervana’s seminars in that city.
Bodor, who treats patients with joint pain, said it was unclear from the seminar he attended whether Nervana’s umbilical stem cells are live (which could violate federal standards that they be used only on related family members) or dead (which means they technically aren’t stem cells, capable of regenerating).
But, he noted, even if not using live stem cells, Nervana’s injections could provide the same lubricating benefits as simple saline solutions. “We know that just injecting saline into a knee can make it better,” he said.
Knoepfler and others are urging the FDA to clarify regulations so that clinics and consumers will know what’s an approved, beneficial treatment and what’s not.
“There’s a gray zone where these clinics are operating,” said the California institute’s McCormack. “The FDA needs to address the issue of these clinics and address this slow, onerous approval process for stem cell therapy.”
As clinical trials proceed and the FDA works on finalizing its guidelines, anyone considering stem cell treatment should be cautious, said experts.
“When you buy a car, you’re skeptical of mileage claims. Bring that same level of skepticism when you’re dealing with a medical treatment that really isn’t proven,” said Knoepfler. “Talk to your personal physician. Do your research and ask a lot of questions. Err on the side of caution.”