The U.S. Food and Drug Administration announced a crackdown on stem-cell clinics marketing and selling unapproved and potentially harmful therapies for cancer and other diseases.
The agency took action against two large clinics in Florida and California, which have started selling treatments that the agency says use stem cells but have not been approved as safe and effective by the FDA.
"A small number 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," FDA Commissioner Scott Gottlieb, M.D., said in a statement.
The FDA issued a warning letter to US Stem Cell Clinic of Sunrise, Florida, after an inspection in which the agency found that the clinic was processing body fat into stem cells and administering the product both intravenously or directly into the spinal cord of patients with , , chronic obstructive pulmonary disease (COPD), and pulmonary fibrosis.
"The FDA has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use," the agency said in a statement.
During the inspection, investigators also reported the clinic deviated from guidelines put in place to prevent microbiological contamination, which puts patients at risk for infections, the agency said.
Also this week, the FDA seized five vials of a smallpox vaccine from StemImmune Inc. in San Diego, California, which the agency said was used to create an unapproved treatment of stem cells and excess amounts of the vaccine, which was then administered to cancer patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.
The FDA says this treatment put patients at risk for potential harms including inflammation and swelling of the heart and surrounding tissues.
The agency said it will investigate how StemImmune Inc. obtained the vials of the vaccine, which each contained 100 doses. The vaccine is not commercially available and is reserved only for people considered at high risk for smallpox, such as some members of the military. One vial was partially used, while four of the vials were still intact, the FDA reports.
"I've directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk," Gottlieb said.
In response, Dr. Mark Berman, co-founder of the California Stem Cell Treatment Centers, told the Los Angeles Times that the comments from the FDA are "disparaging and misrepresentative," and said they showed "a lack of understanding" of surgical procedures in which patients' own stem cells are used to promote regeneration.
Berman, who is also director of stem cell implantation at StemImmune, called the clinic's products "cutting edge cancer therapy" for Stage 4 cancer patients, the Times reports.
US Stem Cell Clinic posted a response to its website, saying, "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."
"The FDA has stated that they will have specific stem cell guidelines by the 21st Century Cures Act deadline of December 13, 2017 and we intend to follow those standards as well," the statement continues. "We have helped thousands of patients harness their own healing potential. It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards."