No COVID claims for exosome product, warns FDA
A firm that manufactures human stem cell and exosome products was cited by the US Food and Drug Administration (FDA) for marketing an exosome product to treat or prevent the novel coronavirus, COVID-19 without premarket review or approval.In the warning letter dated June 4, FDA quoted EUCYT Laboratories’ website, which claimed that “COVIXO drives cellular functionality including augmenting the type 1 interferon pathway ... that is important for anti-SARS-CoV-2 activity” and “[t]he unique mechanism of action for COVIXO enables each patient to generate their own adaptive immune response against SARS-CoV-2, including memory T cells and antibodies, which will further protect each patient from subsequent exposures and infections.”
The COVIXO product was not the sole subject of the warning letter, which followed a November 2019 inspection of the company’s Las Vegas facility. “None of your products are the subject of an approved biologics license application (BLA), nor is there an [Investigational New Drug application] in effect for any of them,” said the FDA.
The agency’s ongoing enforcement efforts to curb the marketing of unapproved stem cell therapies have cited multiple firms that are processing and marketing human cell, tissue, or cellular or tissue-based products that do not meet exceptions in 21 CFR 1271.15 or the criteria of 21 CFR 1271.10(a), and are not regulated solely under section 361 of the Public Health Service Act and 21 CFR 1271. (RELATED: FDA continues stem cell enforcement with new warning letter, safety notification, Regulatory Focus 09 December 2019)
The investigation also uncovered “significant deviations” from current good manufacturing practice and current good tissue practice. Specific deficiencies included gaps in donor eligibility practices, unvalidated manufacturing processes, problems with environmental monitoring and inadequate aseptic practices. Taken together, these deviations “pose a significant risk that your products may be contaminated with viruses or microorganisms or have other serious product quality defects,” noted the warning letter.
Aseptic processes for the stem cell and exosome products had not been validated since the commencement of manufacturing in April of 2018, although the product labeling indicates that the products are expected to be sterile. Additionally, FDA inspectors found multiple lapses in establishing and following written procedures throughout the manufacturing, sampling, and packaging processes.
In all, 152 sterility failures were identified between April 2018 and November 2019. Organisms identified included Clostridium perfringens, Enterococcus Faecalis, Escherichia coli, Klebsiella pneumonaie, and others. EUCYT destroyed the batches containing these organisms without thoroughly investigating the contamination, said the FDA.