FDA warns Florida stem cell clinic about GMP deviations
- In a warning letter that stretches to around six pages, the Food and Drug Administration has pointed out a host of failings at the U.S. Stem Cell Clinic. These include 14 separate points on current good manufacturing practice (cGMP) and good tissue practice (cGTP)
- These "significant deviations," documented between Dec. 8, 2015, and April 17, 2017, related to stromal vascular fraction (SVF) from donated adipose tissue, and included the same or similar deviations found following the FDA's previous inspection in late 2015.
- The issues raised by the FDA, which affect at least 256 lots of stem cell products, include failure to ensure sterility and purity of the products, a lack of records of cleaning and maintenance, inappropriate protective clothing and lack of quality control.
The U.S. Stem Cell Clinic, based in Sunrise, Florida, processes adipose tissue from donors to create SVF, which it then gives to patients either intravenously or intrathecally, claiming that it can treat a range of diseases including Parkinson’s disease, amyotrophic lateral sclerosis, chronic obstructive pulmonary disease, heart disease and pulmonary fibrosis.
But the latest FDA inspection shows its manufacturing processes potentially put patients at risk, as does its use of untested and unapproved cell therapies in the treatment of patients with a range of serious and life-threatening diseases.
"Our aim is to provide an efficient route to market for promising technologies," said FDA Commissioner Scott Gottlieb in a recent statement about regenerative medicines. "But at the same time, we will take a firm stance against those that prey on the medical promise of regenerative cell therapies to market treatments potentially unsafe or unproven so-called cures. We want a regulatory framework that helps efficiently and effectively advance the many promising technologies in the field of regenerative cell therapies. The FDA can’t allow a small number of bad actors to leverage that promise to mislead patients and put them at risk."
The clinic claims that it does not need to comply with FDA regulations, including manufacturing, as its procedures fell within the practice of medicine covered by a surgical exemption. But the FDA isn't having that, and its warning letter states that the SVF product "is a drug as defined in section 201(g) of the FD&C Act and a biological product as defined in section 351(i) of the PHS Act".
As it is defined as a drug, it should also be covered by an investigational New Drug Application or a Biologics Licensing Application for use in humans, and must meet cGMP and cGTP requirements in preparation, manufacture and storage. The clinic perhaps didn't help itself by delaying the inspection "by refusing to allow entry except by appointment only" and denying access to its employees.
"Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk," said Gottlieb. "As the FDA takes new steps to advance an efficient, modern approach to the regulation of cell based regenerative medicine, at the same time we will be stepping up our enforcement actions against clinics that abuse the trust of patients and, more important, endanger their health with unsanitary conditions or by purporting to have treatments which may not provide any benefit."
The U.S. Stem Cell Clinic has 15 working days to respond, and to provide details of how it plans to correct the deviations in the warning letter.
The focus on this clinic, and the level of detail of the inspection, reflects the FDA's increased oversight on enforcement of the existing rules, announced this week. This new framework includes both a lower-cost and more streamlined process for individual providers and companies to gain approval for products and procedures, and a new working group to pursue unscrupulous clinics.
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