CDC and FDA Conduct Investigations Into Umbilical Cord Stem Cell Products That Infected 12 People (So Far)
The patients were in Arizona, Florida and Texas and the stem cell products, derived from umbilical cord blood, were processed by Genetech and distributed by Liveyon. None of the products as used in this case are approved by the U.S. Food and Drug Administration (FDA) or marketed legally.
Infections were from E. coli, Enterococcus faecalis and Proteus mirabilis. Unopened products from a Florida clinic were found to be contaminated with E. Coli and E. faecalis. The CDC issued a recall.
On November 29, the FDA issued a warning letter to Genetech, identifying umbilical cord blood-derived cellular products ReGen5, ReGen10 and ReGen30 as products that failed to meet safety regulations. These therapies are used to treat a variety of orthopedic conditions.
The agency also reported yesterday that it sent letters to 20 other stem cell treatment providers, reminding them of the FDA’s regulations about regenerative medicine.
The CDC noted, “Umbilical cord blood cannot be decontaminated after collection because there are currently no validated processes for sterilization, so manufacture of derived products must be highly controlled to prevent the distribution of contaminated products. The Genetech-processed, Liveyon-distributed product is not FDA-approved or lawfully marketed…. Regardless of when contamination occurred, this investigation highlights the serious potential risks to patients of stem cell therapies administered for unapproved and unproven uses other than hematopoietic or immunologic reconstitution.”
In a statement, FDA Commissioner Scott Gottlieb said, “We see a lot of promise from stem cell treatments, but we also have a lot of concern, and we started by sending these 20 letters singling out these firms that should be engaging with FDA but haven’t been. In addition, we are also stepping up our inspections this year. We are concerned that there are firms whose actions could be putting patients at risk and might be subject to additional action.”
At this time, the FDA has only approved the umbilical cord blood-derived stem cell products for hematopoietic or immunologic reconstitution. In other words, for people who have diseases that affect their marrow or blood, such as for blood or bone marrow transplants.
The patients who developed infections were receiving stem cell products for general pain, osteoarthritis, back pain, a rotator cuff tear with a cyst, and rheumatoid arthritis pain.
In an article in The New England Journal of Medicine in March 2018, FDA scientists noted that some physicians believe that stem cells can “sense the environment into which they are introduced and address whatever functions require replacement or repair,” but that “is not based on scientific evidence.”
According to the CDC, Liveyon issued a national recall of ReGen series products in October and halted shipment of the products until the FDA investigation is completed. At this time, the CDC suspects the contamination of the products happened before distribution and is looking at the manufacturing and safety practices at the clinics as well.
The FDA indicated that in June it had inspected the Genetech manufacturing facility and found “significant deviations,” including “deficient donor eligibility practices; unvalidated manufacturing processes; uncontrolled environment; lack of control over the components used in production and a lack of defined areas or a control system to prevent contamination and mix-ups.”
The CDC is also continuing its investigation to determine if other patients received the contaminated products.
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