StemGenex Biologic Laboratories recently drew a warning letter from the U.S. Food and Drug Administration over manufacturing practices and the marketing of an unapproved stem cell therapy.
The FDA letter stated San Diego-based StemGenex pitched its product for life-threatening conditions like Alzheimer’s disease despite being without a license or requisite approval. The company does what’s called stromal vascular fraction, or SVF, a type of stem cell therapy in which stem cells are harvested from body fat.
In addition, an FDA inspection in January found “deviations from current good manufacturing practice requirements, including some that could lead microbial contamination, putting patients at risk,” the FDA said in a Nov. 13 news release.
The FDA in the last year has sought to target bad actors in regenerative medicine.
“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,” FDA Commissioner Scott Gottlieb said in the news release.
The FDA stated StemGenex’s SVF product is only in the development stage. The company must obtain a valid biologics license for marketing and complete an investigational new drug application for use in humans, according to the agency.
StemGenex did not immediately return a request to comment.