The Food and Drug Administration has issued a warning to Genetech Inc. regarding the marketing of unapproved umbilical cord blood-derived products (ReGen5, ReGen10, and ReGen30) that were distributed by Liveyon, LLC.

These products were being marketed without FDA approval for the treatment of a variety of orthopedic conditions via intra-articular or intravenous injection, or by direct application to affected tissue. Additionally, the Agency stated that an inspection of the Company’s facility found evidence of “significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP).”

In September, Liveyon suspended shipment of these stem cell products and conducted a voluntary recall pending the FDA inquiry. The Agency is so far aware of 12 individuals who received the products and became ill due to blood and other infections caused by microbial contamination. The details surrounding these cases can be found in the Centers for Disease Control and Prevention (CDC)’s Morbidity and Mortality Weekly Report (MMWR).

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“We’ll be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients,” said FDA Commissioner Scott Gottlieb, MD.

Letters have also been sent to other manufacturers who may offer stem cell treatments, to remind them of the compliance and enforcement policy.

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