Marilyn Kirchoff is in pain.
"I've got tears in my rotator cuffs," she says. "Complete tears. I had this really bad pain in my hip, going down my leg. It pretty much limited me."
The retired computer programmer leads a quiet life in a cabin-style home, atop a ridge in the Santa Cruz Mountains just south of Los Gatos. But the constant pain left her desperate for relief.
"I wanted to fix all that, so I didn't feel like I was 80 years old," Kirchoff said.
An advertisement she received in the mail got her attention. The flyer from Advanced Health Center in San Jose offered the relief she sought, using what it called "stem cells."
Kirchoff followed up by attending a seminar, where she says chiropractic clinic staff assured her the treatments were very likely to work.
"Eighty-percent chance of success," Kirchoff said. "That sounds really good. So I signed that contract, for almost $13,000."
Medical records from the clinic show she received four injections for her money: two in her hips, and two in her shoulders.
Did it work? Kirchoff says no.
"I got nothing for my money," she said. "I got nothing."
Experts Question Effectiveness
Marilyn's sister, Barbara Lietzan, got the "stem cell" treatment, too. She visited the same clinic, paid about the same amount of money -- and, she says, got the same result.
"I had to take money out of my 401(k)," Lietzan said. "I cannot tell you any relief that I received. No relief."
Kirchoff and Lietzan say they asked for refunds, but Advanced Health Center declined – citing their treatment contracts, which specify no guarantees and no refunds. That’s when both women contacted NBC Bay Area. For more than six months, we spoke with more than a dozen doctors, scientists, researchers, regulators, and medical experts nationwide. All voiced the same concerns: stem cell therapies marketed for relief of chronic pain are not proven to work.
Among the skeptics is Kevin McCormack, communications director for the California Institute for Regenerative Medicine. His taxpayer-funded agency funds research into stem cell treatments for a variety of diseases.
McCormack has little regard for commercially available stem cell injections targeting chronic pain.
"There are a huge number of clinics that are going up, that are offering what we would call 'bogus therapies,'" McCormack said. "Things that haven't been proved. Things that haven't been approved, by the FDA."
We showed McCormack the advertisement that drew Kirchoff to seek stem cell therapy. In bold text, it reads: "Don't mask your pain, FIX IT!" and lists ailments including "knee pain," "hip pain," "arthritis," "back pain" and "shoulder pain."
We asked McCormack if stem cells are approved for treatment of any of those problems. His answer to each: "No."
"It's approved for bone marrow transplants, that have been around for a number of years; and three conditions -- two of them quite rare -- and one for spinal muscular atrophy in children."
Dr. Joanne Kurtzberg, president of the Cord Blood Association, shares that skepticism.
"There's no proof they help," Dr. Kurtzberg said. "I don't think those procedures should be done, unless they're being investigated under an IND [Investigational New Drug application] from the FDA."
A Wide Array of Research
Seeking more answers, NBC Bay Area turned to one of the world's leading experts on cellular biology: Nobel Prize-winning scientist Dr. Randy Schekman, a researcher and professor at the University of California, Berkeley.
Dr. Schekman's decades of work have contributed to discoveries that hold great promise for treating leukemia, Parkinson's disease, and diabetes.
"Embryonic stem cells are ground zero," Dr. Schekman said. "They have infinite possibilities."
But the scientist told us he's skeptical of any claims that stem cell injections offered by commercial clinics, outside of a research setting, could offer pain relief.
"I would be very cautious about this," he said. "I'm not aware of [stem cells] being applied to any approved method for application for human disease."
Federal approval to treat aches and pains is likely years away and not guaranteed. Dr. Schekman says stem cell injections that are part of a registered clinical trial might be OK. But, we asked, would he seek stem cell therapy at a chiropractic clinic?
"Under no circumstances," he said.
Investigating the Injections
Still, lots of patients are getting stem cell treatment for pain.
NBC Bay Area made numerous requests of Advanced Health Center, asking it to review Kirchoff and Lietzan's cases. We also asked it to tell us what was in the injections. It declined to participate in our story.
Dr. Schekman says it's unclear whether "stem cell" clinics are actually using living stem cells on patients.
"The patient has no way of knowing," he said. "Who knows what's being injected? It might not be any kind of stem cell at all."
We asked Kirchoff if she knows what they actually injected into her.
"No," she said. But: "I had asked for my medical records, and there's a piece of paper that says this vial came from Surgenex."
Medical documents show that vial contained a product called "Surforce." Its manufacturer, Surgenex, says it's made from donated "placental tissue." Other suppliers say they use similar material.
Doctors and other experts we talked to were skeptical that by the time placenta is processed and injected into a patient, any stem cells would still be alive.
We tried to get more details and a sample of Surforce from Surgenex. The company did not return our calls.
FDA Advises Caution, But Holds Back
The U.S. Food and Drug Administration tells NBC Bay Area there are about 700 commercial "stem cell" clinics nationwide. In September, it released this cautionary video about unapproved stem cell treatments:
If stem cell treatments for pain aren't FDA approved, why doesn't the agency shut down stem cell clinics and their suppliers?
It has targeted a few when patients have reported injury. In one case, it shut down a Florida clinic where the FDA says three patients went blind after receiving "stem cell" injections in their eyes.
Still, the FDA says the stem cell industry straddles a gray area of enforcement. That might change next year; the FDA issued a warning letter to clinics, telling them to expect extra scrutiny starting in November 2020.
For now, the FDA says buyer beware -- especially since insurance doesn't cover unapproved stem cell injections.
Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research, compares seeking stem cell treatments to vehicle shopping.
"You don't want to buy a car that turns out to have an engine that doesn't work," Dr. Marks said. "You're paying money out of your pocket for that. For these unapproved therapies that are being offered, people are paying money out of pocket, and unfortunately, if [the therapies] don't work, even if they aren't necessarily harmed physically, they can be harmed very much financially."
Following the Money
There's a financial incentive for suppliers and clinics to offer stem cell therapy. Online, medical consultants are promoting stem cells to chiropractors. One in Arizona touts an easy "new revenue stream." Another in Florida posts testimonials from chiropractors on YouTube. Among them is Dr. Brian Coyle, co-founder of Advanced Health Center in San Jose -- the clinic that treated Kirchoff and Lietzan.
"We're going to definitely double our practice," Coyle says in the video, "and easily make a million dollars more next year, just from the information on how to change our seminar, and be able to close more people."
Still Awaiting Answers
NBC Bay Area wanted to talk to Dr. Coyle, or anyone else at Advanced Health Center. The clinic never responded to our emails, so we went in person. It declined to speak with us.
That's the same response we got from everyone else we contacted in the stem cell industry: doctors; manufacturers; suppliers; consultants -- silence.
Kirchoff feels she's being ignored, too. She's filed complaints with the California Board of Chiropractic Examiners and other state agencies. Until then, she wants others to hear her story, and think carefully before investing in "stem cell" treatments.
"They get your hopes up, and you think, 'Oh my God, it's the Fountain of Youth! It's going to fix all my problems,'" she said. "And then you're so crushed when it doesn't do anything for you. And, they got your money."
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