FDA Cracks Down on Stem Cell Clinics to Weed Out 'Bad Actors'

Megan Brooks

Disclosures

August 28, 2017

The US Food and Drug Administration (FDA) has announced new steps to increase oversight of clinics and companies offering stem cell therapies in an effort to weed out "bad actors."

In the last few days, the FDA has taken steps in Florida and California to address several "especially troubling" stem cell products being marketed, FDA Commissioner Scott Gottlieb, MD, said in a statement.

On August 24, the FDA sent a warning letter to US Stem Cell Clinic of Sunrise, Florida, for marketing stem cell products without FDA approval and for failing to adhere to good manufacturing practice requirements. Some of these could affect the sterility of their products, putting patients at risk.

In a recent inspection of US Stem Cell Clinic, the FDA discovered that the clinic was processing adipose tissue into stromal vascular fraction and administering the product both intravenously or directly into the spinal cord of patients to treat a variety of conditions, including Parkinson's disease, amyotrophic lateral sclerosis, chronic obstructive pulmonary disease, heart disease, and pulmonary fibrosis.  The FDA has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use.

The inspection also turned up evidence of "significant deviations" from good manufacturing practices in the manufacture of at least 256 lots of stem cell products by the clinic. For example, the clinic was cited for failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile.

During its most recent inspection, US Stem Cell Clinic also tried to impede the FDA's investigation by refusing to allow entry except by appointment and by denying FDA investigators access to employees. "Refusing to permit entry or FDA inspection is a violation of federal law," the FDA said.

The FDA has asked US Stem Cell Clinic to respond to their concerns, including corrective actions, within 15 working days.

Significant Risk for Patient Harm

StemImmune Inc of San Diego, California, is also on the FDA's radar.  On August 25, the agency said it took "decisive action to prevent the use of a potentially dangerous and unproven treatment" belonging to the company and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.

On behalf of the FDA, the US Marshals Service seized five vials of vaccinia virus vaccine (live), which is reserved for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100 doses of the vaccine, and although one vial was partially used, four of the vials were intact, the FDA said.

Because the vaccine is not commercially available, FDA said it has "serious concerns" about how the company got it, which they are now "actively" investigating.

The seizure comes after recent FDA inspections at StemImmune Inc and the California Stem Cell Treatment Centers found that the vaccine was used to create an unapproved stem cell product (a combination of excess amounts of vaccine and stromal vascular fraction), which was then given to patients with cancer, either intravenously or directly into patients' tumors.

"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," said Dr Gottlieb.

Unfortunately, he added, these are examples of a "larger pool of actors who claim that their unproven and unsafe products will address a serious disease, but instead put patients at significant risk. We will seek to take additional actions in the coming months as we address this field, and target those who are clearly stepping over the line, at the same time that they create a potential danger to patients. We have examples where some of these unproven treatments have clearly harmed patients."

"As we work to protect Americans from the bad actors, I'm equally committed to doing all we can to help bring to patients more quickly innovative, scientifically proven regenerative cell therapies. For this reason, we're developing a comprehensive and efficient, science-based policy with the aim of accelerating the proper development of these products," added Dr Gottlieb. 

The FDA says it will provide details of the policy this fall.

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