The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could lead to microbial contamination, putting patients at risk.
The FDA recently inspected the StemGenex facility and found the company was processing adipose tissue (body fat) into stromal vascular fraction (SVF, a cellular product derived from body fat) for administration in a variety of ways, including intravenously, by inhalation, and directly into the spinal canal.
StemGenex illegally markets the SVF product to treat a variety of serious diseases and life-threatening conditions, including Alzheimer’s disease, Crohn’s disease, Type I and Type II diabetes, fibromyalgia, spinal cord injury, chronic obstructive pulmonary disease, multiple sclerosis, muscular dystrophy, Parkinson’s disease, peripheral neuropathy and rheumatoid arthritis.
StemGenex’s SVF product, which involves more than minimal manipulation of a patient’s adipose tissue, is regulated as both a drug and biological product. To lawfully market its SVF product, a valid biologics license must be in effect. While in the development stage, the firm’s SVF product may be used in humans only if an investigational new drug application (IND) is in effect. However, no such licenses or approvals exist for StemGenex’s product, and the firm does not have an IND in effect.
During the inspection, FDA investigators documented evidence of significant deviations from current good manufacturing practice requirements in the manufacture of the 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.
The FDA has requested a response from StemGenex, within 15 working days of the letter’s issuance, that details how the deviations noted in the warning letter will be corrected. Deviations not corrected by companies and owners could lead to enforcement action such as seizure, injunction, or prosecution.
