FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

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Nov 13, 2018, 10:45 ET

SILVER SPRING, Md., Nov. 13, 2018 /PRNewswire/ -- 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 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. This is putting patients' health at risk. It's also putting at risk the long-term viability of the industry and of effective products, when other operators are misleading consumers by marketing unproven therapies using claims of safety and benefit," said FDA Commissioner Scott Gottlieb, M.D. "We support sound, scientific research and regulation of cell-based regenerative medicine. The FDA has advanced a comprehensive policy framework to promote the efficient approval of regenerative medicine products. At the same time, we'll continue to take enforcement actions against companies that abuse the trust of patients and endanger their health with uncontrolled manufacturing conditions or by promoting so-called 'treatments' that haven't been proven safe or effective for any use."

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.

Health care professionals and consumers should report any adverse events related to treatments with the StemGenex product to the FDA's MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

For more information:

FDA: Comprehensive Regenerative Medicine Policy
FDA: FDA Warns About Stem Cell Claims
FDA: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Stephanie Caccomo, 301-348-1956, [email protected]
Consumer Inquiries: 888-INFO-FDA, [email protected]

SOURCE U.S. Food and Drug Administration