FDA Expands Crackdown on Stem Cell Clinics

By Pat Anson, Editor

The Food and Drug Administration is stepping up its campaign against experimental stem cell therapies, which are increasingly being used to treat cancer, diabetes, neuropathy, back pain and other chronic illnesses.

On Friday, the FDA raided two stem cell clinics operated by California Stem Cell Treatment Centers, and seized five vials of a smallpox vaccine supplied by StemImmune in San Diego. The vaccine is mixed with stem cells derived from a patient’s body fat – known as adipose tissue -- and then injected back into the patient. The FDA considers that “an unapproved and potentially dangerous treatment” for cancer.

On Monday, the FDA also sent a warning letter to a stem cell clinic in Florida, which advertises stem cells derived from body fat to treat a variety of chronic illnesses, including rheumatoid arthritis, lupus and other autoimmune diseases. Three elderly women at the clinic went blind after having stem cells injected into their eyes in an attempt to treat macular degeneration.

in a lengthy statement announcing the crackdown,  FDA commissioner Scott Gottlieb, MD, said stem cell therapy and regenerative medicine hold “significant promise for transformative and potentially curative treatments,” but some “bad actors” were preying on sick people desperate to find cures.

“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products,” Gottlieb warned.

“In such an environment a select few, often motivated by greed without regard to responsible patient care, are able to promote unproven, clearly illegal, and often expensive treatments that offer little hope, and, even worse, may pose significant risks to the health and safety of vulnerable patients.”

stem cells.jpg

Dr. Mark Berman, a co-founder of California Stem Cell Treatment Centers, told the Los Angeles Times that Gottlieb’s comments were "disparaging and misrepresentative," and showed "a lack of understanding" of stem cell treatments. 

As PNN has reported, hundreds of stem cell clinics have opened around the country in recent years, often mixing hope with hype to make claims such as “You don’t have to accept chronic pain as a fact of life.”  The treatments are expensive and usually not covered by insurance.  A clinic in Sacramento, for example, charges $5,000 for a single joint injection and $6,000 for a spinal injection.

FDA officials say there is not enough evidence to support some of the newer stem cell therapies – particularly when cells are harvested from a patient’s own body fat (adipose tissue).

“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,” wrote Robert Califf, MD, Gottlieb’s predecessor as FDA commissioner, in a commentary published in the New England Journal of Medicine.

Some patients, however, have reported remarkable recoveries from chronic conditions often deemed untreatable. Sara Bomar, for example, was confined to a wheelchair after being diagnosed with arachnoiditis, a painful inflammation of nerves in her spinal column. She started walking again after a high dose infusion of stem cells made from adipose tissue.

“I am able to walk. I am able to workout at the Y. I am still careful. It’s not like I don’t ever have any pain, I do have a little bit from time to time. But it is nothing compared to what I had before,” Bomar told PNN.

Gottlieb said the FDA would release new guidelines in the fall to outline what types of stem cell therapy and regenerative medicine would be allowed. And he warned that more enforcement actions were coming, like the ones in Florida and California.

“I will not allow these activities to go unchecked. I’ve directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health,” Gottlieb said.

Some patients who have the resources are heading to Europe to get regenerative treatments that can't get in the U.S.  The Seattle Seahawks this week sent five more players to Germany to have their blood processed and re-injected to treat nagging injuries. The procedure involves withdrawing blood from the patient and then spinning it to produce a high concentration of platelet cells. The plasma is then injected back into the patient at the injury site, speeding up the healing process. Two other Seahawks have already had the procedure, along with athletes such as Kobe Bryant and Alex Rodriguez.