The US Food and Drug Administration (FDA) has issued StemGenex Biologic Laboratories a warning letter following an inspection of its San Diego facility.
StemGenex manufactures and sells stromal vascular fraction (SVF) drug product to treat a variety of diseases, including Alzheimer’s, Crohn’s, Parkinson’s, Type I and Type II diabetes, multiple sclerosis, and rheumatoid arthritis.
During the audit, FDA investigators observed “significant deviations” from current good manufacturing practice (cGMP) requirements in the manufacture of the firm’s SVF product, “including unvalidated manufacturing processes, an uncontrolled environment, lack of control over the components used in production, and the lack of sufficient and validated product testing.”
In addition, the agency has claimed StemGenex put patients at risk by illegally marketed the drug.
“Your SVF product is not the subject of an approved biologics license application nor is there an investigational new drug [application] in effect.
“Based on this information, we have determined that your actions have violated the Food, Drug and Cosmetic Act and the Public Health Service Act,” according to US regulator.
Gottlieb: Long-term viability of stem cell industry at risk
Yesterday, FDA commissioner Scott Gottlieb spoke out against ‘bad actors’ in the stem cell therapy space.
“The potential health benefits of regenerative medicine have spurred major progress in stem-cell biology over the past several decades. But we continue to see bad actors exploit the scientific promise of this field to mislead vulnerable patients into believing they’re being given safe, effective treatments; when instead these stem cell producers are leveraging the field’s hype to push unapproved, unproven, illegal, and potentially unsafe products,” said the commissioner.
According to Gottlieb, such practices are putting the industry’s long-term viability at risk.
“We’ll continue to take enforcement actions companies that … [promote] so-called ‘treatments’ that haven’t been proven safe or effective for any use,” he added.
StemGenex did not respond to a request for comment ahead of publication.