2017-08-28 14:30:03
F.D.A. Cracks Down on ‘Unscrupulous’ Stem Cell Clinics

WASHINGTON — The Food and Drug Administration announced a crackdown on dangerous stem cell clinics on Monday, while at the same time pledging to ease the path to approval for companies and doctors with legitimate treatments in the growing field.

The agency reported actions against two large stem cell clinics and a biotech company, saying that it was critical to shut down “unscrupulous actors” in regenerative medicine, a broad umbrella that includes stem cell and gene therapies and immunotherapies.

“The F.D.A. will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work,” said Dr. Scott Gottlieb, the F.D.A. commissioner.

Stem cells, which can be extracted from bone marrow, blood or fat, can develop into many different types of cells, and are thought to have the potential to repair or replace tissue damaged by disease, injury or aging. But so far, the F.D.A. has approved only a few stem-cell products to treat certain blood disorders.

The companies that the F.D.A. cited have been performing liposuction to remove belly fat from patients, extracting stem cells and then injecting those cells back into the patients to treat various ailments.

On Friday, the agency said, federal marshals seized 500 doses of live Vaccinia virus vaccine for smallpox belonging to StemImmune Inc., a San Diego firm that develops stem cell-based immunotherapies for cancer. The raid came after the F.D.A. learned that the vaccine was being used to create an unapproved stem cell product, a combination of excess amounts of vaccine and stem cells derived from body fat, which was then administered to cancer patients with potentially compromised immune systems.

The F.D.A. said patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, Calif., 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 C.D.C. 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 C.D.C. that it was going to inject the vaccine into patients.

The F.D.A. also issued a warning letter to U.S. Stem Cell, a private clinic in Sunrise, Fla. 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 F.D.A.’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 F.D.A. inspectors, or having sterility problems. I “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 F.D.A. 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 F.D.A. noted that U.S. Stem Cell had claimed its work was not subject to agency regulation. The F.D.A. 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.

The other two companies did not respond to requests for comment.

Dr. 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,” Dr. 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. They also train other physicians to perform liposuction, extract stem cells from the fat and inject the cells to treat a long list of ailments, including heart disease, back and knee pain, asthma and neurological disorders.

After training, the physicians can become affiliates of the Cell Surgical Network, which has more than 60 members around the country. Patients are charged $8,900 per procedure, Dr. Berman said in a previous interview. He said affiliates purchase a centrifuge and incubator from the network for about $29,000, and pay the network $1,000 for disposable liposuction equipment needed for every procedure they perform.

Dr. Gottlieb said the F.D.A. 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 F.D.A.’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,” Mr. Werner said.

Public health advocates praised the F.D.A. for moving against the companies, but said it should have happened sooner, given the widespread knowledge of public harm.

“We certainly welcome this type of action, although it comes belatedly,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “The agency has known about these unscrupulous actors for years.”