ReGen30

ReGen30 is an unapproved human cellular product derived from umbilical cord blood that was marketed for the treatment of various orthopedic conditions, including joint pain, arthritis, and fractures. Manufactured by Genetech, Inc. and distributed by Liveyon, LLC, the product was part of a series (including ReGen5 and ReGen10) intended for administration via intra-articular injection, intravenous injection, or direct application to affected tissues. In late 2018, the FDA issued a warning letter to the manufacturer for marketing these products without the required Biologics License Application (BLA) or Investigational New Drug (IND) application. Furthermore, the CDC reported that at least 12 patients were hospitalized with serious bacterial infections, such as *Escherichia coli*, after receiving contaminated ReGen series products, leading to a national recall. The product was marketed as a mixture of stem cells and growth factors intended to promote tissue regeneration and provide systemic therapeutic effects.

Brand names

ReGen30ReGen-30ReGen 30

Other names

Genetech umbilical cord blood-derived productLiveyon ReGen30