U.S. cracks down on ‘unscrupulous’ stem cell clinics
The FDA said patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California, received the treatment made with the smallpox vaccine. It also said it had serious concerns about how StemImmune obtained the vaccine for use in an unapproved and potentially dangerous treatment.
StemImmune obtained at least some of the vaccine from the Centers for Disease Control and Prevention, according to Thomas Skinner, a CDC spokesman. In its request, the company said it was conducting cancer research involving the vaccinia virus, and needed to vaccinate researchers — a seemingly legitimate reason. The company did not tell the CDC that it was going to in- ject the vaccine into patients, he said.
A statement from StemImmune said the company had lawfully obtained the drug.
The FDA also issued a warning letter to U.S. Stem Cell, a private clinic in Sunrise, Florida. The company was the subject of a March report in The New England Journal of Medicine, describing how one woman went blind and two others suffered severe, permanent eye damage after being given shots of stem cells, extracted from fat, into their eyes.
The warning letter accused the company of impairing the FDA’s ability to conduct its inspection by refusing to allow inspectors in, and denying them access to employees. It also said that U.S. Stem Cell had failed to establish proper quality control and sanitary standards.
In a statement Monday afternoon, U.S. Stem Cell denied ever restricting access to FDA inspectors, or having sterility problems. “The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration,” it said.
Noting that the FDA has asked patients with concerns to come forward, the company said it had asked patients who have had positive experiences with their stem cell treatments to notify the agency.
But in the warning letter, the FDA noted that U.S. Stem Cell had claimed its work was not subject to agency regulation. The FDA disagreed, saying that the cells extracted by the company met the definition of both a drug and a biological product, both of which come under the agency’s jurisdiction. In its statement, U.S. Stem Cell said it would abide by the new rules the agency is developing for the field.
Gottlieb said it was imperative to shut down fraudulent and unsafe players in the field in order to take advantage of the promise of stem cell therapies and to increase innovation in the regenerative medicine field, a program authorized by Congress in the 21st Century Cures Act.
Those enterprises “put the entire field at risk,” Gottlieb said. “Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science.”
The California Stem Cell Treatment Centers were founded in 2010 by Dr. Mark Berman, a plastic surgeon, and Dr. Elliot Lander, a urologist. Berman defended the company, and said that the FDA had not accurately interpreted its cancer pilot study with StemImmune. Berman, who is also a director of StemImmune, also said that none of the patients had experienced serious adverse effects or died as a result of the treatment involving the vaccine, which he noted, was free.
Gottlieb said the FDA would soon publish documents detailing which new treatments and products are subject to agency regulation, and which are not, and giving details on a new, expedited path for companies with legitimate products, seeking premarket approval.
Some industry representatives applauded the move.
“The FDA’s proposal is clear evidence of the fact that the regenerative medicine sector has matured and has moved from just a research sector to a development of market ready products,” said Michael Werner, a partner in the law firm of Holland & Knight and the executive director of the Alliance for Regenerative Medicine. “He’s clearly distinguishing unscrupulous actors who are playing upon hype and taking advantage of patients and product developers who are actually going to treat diseases.”
“He is trying to balance patient safety and a regulatory pathway that is as least burdensome as possible,” Werner said.