Liveyon LLC, a marketer and distributor of stem cell products manufactured by Genetech Inc., is recalling products from its ReGen Series after receiving reports of adverse events.
Liveyon was contacted in September 2018 by the Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research (CBER), which oversees human cells and tissue-based products, regarding concerns that products manufactured by Genetech and reports of possible adverse reactions in patients who were treated with the ReGen Series products.
“Liveyon immediately suspended shipment of all product pending an inquiry by CBER into the source of the adverse reactions,” the company said in a news release. “In addition, Liveyon voluntarily recalled any Genetech products it may have distributed.”
According to Chris Centeno, M.D., a specialist in regenerative medicine with Regenexx and the new field of Interventional Orthopedics, the recalled products are derived from either the amniotic sac/fluid or the umbilical cord blood/Wharton’s jelly. The adverse events that led to Liveyon’s recall were not specified, but “if it was due to bacterial contamination, this has some very real risks. If this stuff is injected into a knee, the knee will likely develop septic arthritis (loss of cartilage due to the infection eating away at the joint,” said Dr. Centeno, a pioneer in orthopedic stem cell procedures who has published a large amount of research on stem cell use for orthopedic applications.
“However, more concerning is that we have seen chiropractic and acupuncture clinics buying this stuff and injecting it IV. If one of these products ends up being given that way, this would lead to sepsis and possible death,” Dr. Centeno warned.
Liveyon said it immediately discontinued the purchase of any product from Genetech and has procured new product from an alternative umbilical cord blood/tissue bank that manufacturers the product in a cGMP compliant facility that is also accredited by the America Association of Blood Banks.
FDA Safety Communication