FDA Warns Cord Blood-Stem Cell Company

E. coli bacteria (Agricultural Research Service, USDA)

20 Dec. 2018. The Food and Drug Administration recently warned GeneTech Inc. that its unauthorized stem cell regenerative medicine products, may be causing serious blood infections. The company GeneTech Inc. in San Diego is not related to the biopharmaceutical company Genentech, a subsidiary of drug maker Roche Group, in San Francisco.

FDA’s letter, sent on 29 November, cites GeneTech’s branded treatments for orthopedic conditions derived from umbilical cord blood that the agency says are being marketed by GeneTech for allogeneic use, or by people who are genetically dissimilar to the donors, and thus may cause immune reactions. In the letter, FDA points out that GeneTech’s products are designed for homologous use — i.e., by the donor or someone with a close genetic match — and thus are not made to perform the same functions in the recipient and donor. And since the functioning of donated cells, says FDA, are dependent on the cell’s metabolic activity, the cells may not even work with the donor or close relative.

The agency’s letter also cites numerous violations of good manufacturing practices and standards found in an inspection of GeneTech’s labs and facilities in June 2018. The violations include deficient donor eligibility practices, unvalidated manufacturing processes, uncontrolled environment, lack of control of components used in production, and lack of defined areas or a control system to prevent contamination and mix-ups. The letter notes the violations, “pose a significant risk that your products may be contaminated with microorganisms or have other serious product quality defects.”

FDA says it also received numerous reports of safety concerns. GeneTech distributes its umbilical cord blood products through Liveyon LLC in Irvine, California. In October, Liveyon recalled products in GeneTech’s ReGen line, for reported adverse reactions. FDA and Centers for Disease Control and Prevention say at least 12 pople become ill from E. coli and other bacterial infections after they used GeneTech products. FDA requires a response from GeneTech in 15 working days.

The umbilical cord provides blood and nutrients from the mother to the fetus and is usually discarded after birth. But the cord is made from layers of amniotic membrane and a substance called Wharton’s Jelly that is also a source of stem cells and growth factors, thus increasingly studied as a source of regenerative medical solutions. Science & Enterprise recently reported on derivatives of umbilical cord tissue and blood to treat slow-healing wounds such as foot ulcers and being assessed as a potential treatment for autism spectrum disorder.

FDA says it is also sending letters to other companies marketing therapeutic products claiming to be derived from stem cells of its regulatory guidance on cell and gene therapy. The agency issued those documents in November 2017.

“We’re implementing new policies to make it more efficient to safely develop these promising new technologies,” says FDA commissioner Scott Gottlieb in an agency statement. “At the same time, we’re also focusing more resources on enforcement when we see companies skirt safety measures and put patients at risk. In this case, the company’s failure to put in place appropriate safeguards may have led to serious blood infections in patients.”

More from Science & Enterprise:

• Report – 289 Cell and Gene Therapies in Development
• FDA Updating Expanded Access to Investigational Drugs, Devices
• FDA Clears Some Drug Reaction Genetic Tests, Warns About Others
• FDA Preparing Animal, Plant Biotech Regulatory Guidance
• FDA to Test New Trial Designs, Assess A.I. Models

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