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A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.
FDA announced on June 4, 2019 that US District Judge Ursula Ungaro of the Southern District of Florida held that US Stem Cell Clinic LLC, of Weston, Florida, and US Stem Cell Inc., of Sunrise, Florida, and their Chief Scientific Officer Kristin Comella, PhD had adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue. The ruling came after the US Department of Justice initiated action in May 2018 to seek a permanent injunction against the clinics after attempts by FDA to work with the company to become compliant with regulations failed.
US Stem Cell received a warning letter from FDA in 2017 for marketing stem cell products without FDA approval and for deviations from current good manufacturing practices. During an inspection, agency inspectors found the company was intravenously administrating unapproved product to treat diseases such as Parkinson’s, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease, and pulmonary fibrosis. The company was also cited for failing to have procedures to prevent microbiological contamination of products that were supposed to be sterile.
“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, MD, in a press release. “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. It is our responsibility to promote and protect public health, and we take this responsibility seriously.”
“In the case against US Stem Cell Clinic, the clinic and its leadership have put patients at serious risk through their disregard of the law and prior FDA warnings. This decision today is a victory for the FDA’s work to stop these bad actors and to protect patients,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the release. “We are committed to continuing to pursue actions against those who put patients in harm’s way by marketing unapproved stem cell products that skirt FDA’s regulations and federal law.”