A US district judge has ruled that US Stem Cell Clinic LLC and US Stem Cell Inc. (FL, USA) adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.
In action brought by the US FDA, a US district judge has ruled that two Florida-based clinics adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue. Despite being issued with a warning letter in 2017 for marketing stem cell treatments which had not been approved by FDA, a permanent injunction against US Stem Cell Clinic LLC and US Stem Cell Inc. (FL, USA) was sought in 2018 and has now been granted.
“Cell-based regenerative medicine holds significant medical opportunity, but those in this field who do not operate in compliance with the law can potentially cause serious harm to patients,” said Acting FDA Commissioner Ned Sharpless.
“We support sound, scientific research and regulation of cell-based regenerative medicine. The FDA has advanced a comprehensive policy framework to promote the development and approval of regenerative medicine products. But at the same time, the FDA will continue to take action–such as issuing warning letters or initiating court cases–against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by manufacturing and promoting products in ways that make them drugs under the law, but which have not been proven to be safe or effective for any use.
The 2017 warning followed an FDA inspection of the clinics which found deviations from current good manufacturing practice (cGMP), and no established and followed written procedures for the prevention of microbial contamination. US Stem Cell produced and marketed treatments for indications such as Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis. Permanent action was sought after the clinic failed to work with FDA to comply with the necessary regulations.
Sharpless concluded: “It is our responsibility to promote and protect public health, and we take this responsibility seriously.”