Stem cell treatment: The stem cells are returned to the patients body through an intravenous infusion or an injection directly into the joints, tendons or ligaments.
Hope has fueled the mushrooming growth of private stem cell clinics. The industry has been aided by stories like those of Laurie Hanna.
A skiing accident in the mid-1990s had shredded the cartilage in Hannas knee. Surgery helped the damaged joint, but it still deteriorated over the years, drastically limiting her mobility. When I walked, my knee sounded like crunchy granola, says the 52-year-old nurse anesthetist, who lives in Los Angeles with her son.
When one of the plastic surgeons Hanna worked for, Mark Berman, talked about doing stem cell therapy, she jumped at the chance. What did I have to lose? Hanna says. My only other option was knee replacement surgery.
One morning in January 2010, Hanna arrived at Bermans expansive Beverly Hills office, with comfy leather couches in the waiting room and a state-of-the-art surgical suite. Berman, working in tandem with an orthopedic surgeon, removed fat tissue from her hip, separated out the stem cells and injected those cells into her left knee. After two treatments, Hanna noticed a significant improvement and was able to ski again for the first time in 10 years. I called him on the phone, crying, Hanna recalls. I had back my quality of life.
This is the front edge of a new era of medicine, says Berman, who has expanded the use of stem cell procedures within his broader plastic surgery practice in California and has helped establish a nationwide network of clinics called the Cell Surgical Network. Berman has even performed stem cell treatments on himself and his wife. He says he finds the procedures work best for orthopedic conditions, such as arthritis and hip, back and joint pain. Were using the bodys natural repair mechanisms to reverse cell damage.
While there havent been many reports about serious complications at clinics in the U.S., the lack of oversight does allow abuses. Two patients in Florida died after receiving stem cell injections, and a California woman developed bone fragments in her eyelids after a stem cell face-lift.
In another incident, three older women, paying to participate in what was described as a clinical trial, were blinded after being injected with stem cells at a South Florida clinic to treat their macular degeneration. All three patients had functional vision they could watch TV and get around unassisted, but they worried about the prospect of further deterioration and the potential loss of their drivers licenses. Lured by claims on the clinic website, they each paid $5,000 for injections in both eyes. The turnaround time was about 30 minutes from harvesting the tissue to the injection of stem cells into the vitreous cavity of both eyes, which was done by a nurse without the direct supervision of a doctor.
Within a few days, it was obvious something was wrong they ended up in the ER in severe pain and complained of vision loss. Two of them were referred to Thomas Albini, an ophthalmologist at the University of Miami. He speculates that when the stem cells started dividing, they caused the retina to detach. There was nothing we could do to bring their vision back, Albini says. All three are now legally blind and unable to live independently.
The FDA is struggling with how to police these clinics. The agency held hearings last September and has sent warning letters for safety violations to a handful of the worst offenders. The agency would also like to classify stem cell treatments as drugs, which would mean they would have to go through years of human tests before they could be used commercially.
Beyond isolated horror stories, there are concerns about the treatments performed by certain clinics. Theyre basically fraudulent, says Larry Goldstein, M.D., director of the Stem Cell program at the University of California, San Diego, and scientific director of the Sanford Consortium for Regenerative Medicine. They take advantage of the average persons lack of sophisticated medical information andjudgmentandpromiseimprovements indiseasethat are not reasonable.
But the industry has grown so rapidly in the past several years that its going to require a lot of firepower from government and other regulatory agencies to rein it in, says Turner, the bioethicist at the University of Minnesota. In the meantime, its a Wild West marketplace where anything goes.
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