The FDA warned StemGenex Biologic Laboratories about illegally marketing an unapproved stem cell product produced in a facility with significant manufacturing violations, putting patients at risk.
Here are five things to know:
1. The FDA recently inspected the StemGenex facility and found the company was processing adipose tissue into stromal vascular fraction for intravenous, inhalation and spinal canal administration.
2. FDA investigators found evidence of significant deviations from current 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 lack of sufficient and validated product testing.
3. StemGenex marketed the SVF product to treat a variety of conditions, including spinal cord injury, Alzheimer's disease, Crohn's disease, Type I and Type II diabetes, fibromyalgia, chronic obstructive pulmonary disease, multiple sclerosis, muscular dystrophy, Parkinson's disease, peripheral neuropathy and rheumatoid arthritis.
4. While in the development stage, the company's SVF product may be used in humans only if an investigational new drug application is in effect. StemGenex did not have an IND in effect.
5. The FDA requested a response from StemGenex within 15 working days detailing how deviations noted in the warning letter will be corrected. Uncorrected deviations could lead to seizure, injunction or prosecution.
View the warning letter here.