CDC: Patients Contaminated by Allograft Umbilical Cord Products

If your practice treated patients with certain allograft umbilical cord products which purport to have “stem cells” from a San Diego, California, company called Genetech, Inc.* in the past year, distributed through a Yorba Linda, California company called Liveyon, LLC, you stood a chance of unwittingly infecting them with dangerous pathogens.

*This is not the big San Francisco biotech company, Genentech, Inc. (with an “n” in the middle).

Now, the Food and Drug Administration (FDA) seems to be planning an aggressive, immediate crackdown on processors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) to ensure that any company selling tissue products is not, in fact, selling biologics or drugs – which are regulated under either a BLA or IND protocol.

Here’s the story:

1. On June 18 and 22, FDA inspected the facility at which Genetech produced the human umbilical-cord-blood-derived cellular products called ReGen^®5, ReGen^®10, and ReGen^®30, distributed to orthopedists and other physicians through Liveyon.
2. Liveyon recalled the entire lot of products on or around September 27 amid rumors that someone had been infected with Escherichia coli.
3. On November 29, the FDA issued a harsh Warning Letter to Genetech alleging that the company was not only distributing human cells, tissues, and cellular and tissue-based products (HCT/Ps, a.k.a. stem cells) without adhering to proper FDA HCT/P processing rules and, as a result, Genetech’s collection, processing, and record-keeping methods create a serious danger of widely spreading many potentially deadly diseases.
4. The risk turned out to be more than theoretical. On December 21, the Centers for Disease Control (CDC) published a “Notes from the Field” saying that it had so far discovered 12 cases of Enterobacter cloacae, Citrobacter freundii, Escherichia coli, Enterococcus faecalis, and Proteus mirabilis from Genetech-processed HCT/Ps distributed through Liveyon.
5. On December 20, with the information about the 12 infections in hand, FDA sent an ominous letter to the entire HCT/P industry regarding the commercialization of living cell based tissue forms and any claims that these living cell-based forms provide regenerative medicine benefits.  The letter warned HCT/P processors to contact the FDA to find out what level of regulation their products require.
6. Also, on December 20, FDA issued a press release titled, “FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice.”
7. FDA’s use of the word “providers” seems to mean that the notice is intended for any clinic, physician’s office, or hospital which treats patients with stem cell or other HCT/P products. The release says FDA is “discouraged”—which is probably diplomatic code for “infuriated”—by the industry’s response to a 36-month period of relaxed enforcement granted in November 2017.