E. coli is a type of bacteria that can cause diseases such as serious GI illness if it ends up in the wrong place like in your food. You can spend the night in the bathroom or end up in the hospital or more rarely a grave depending on the subtype of E. coli. Some are harmless or maybe beneficial.
You can imagine that if pathogenic E. coli or similar bacteria are present in a drug product (which can include stem cells) that is injected into a patient’s bloodstream, joint, or tissue then the potential risks are even higher.
Allegedly somehow E. coli or some relative microbe ended up in the purported stem cell product of stem cell clinic supplier Liveyon prior to injection into patients, which in turn led to an FDA recall. However, the exact details behind what happened have been hard to pin down.
A new lawsuit and the accompanying court filing (here) help shed some light on this situation. This is just one of many different lawsuits now, some settled and other still ongoing, that have been filed against stem cell clinic-related businesses. This one is unique in part because a “stem cell” supplier/marketer is a defendant. I put “stem cell” in quotes because although it is marketed that, we don’t really know if there are actual stem cells in there.
In the new suit the plaintiffs, who are patients Galen Dinning, Dorothy O’Connell, and Deborah Williamson, allege that Liveyon’s product was contaminated with bacteria prior to injection, causing them harm. Further, it is alleged that the product had no living stem cells despite the marketing suggesting otherwise. In addition to Liveyon, other defendants in the case include Liveyon’s own past supplier Genetech, One Improved Health, Texas Regional Health and Wellness, and providers Sammy Tao, D.C. and Omar Vidal, M.D.
There is not an isolated case as there was another suit involving Liveyon as well this year and I’m currently looking into that.
I was up in Seattle recently giving a talk on CRISPR and several people mentioned to me that the newspaper up there, The Seattle Times, continues to run many huge ads for unproven stem cell clinics. Someone even saved one of these ads to show me. These ads seem to sell dubious birth-related “stem cell” products that may not contain any living cells let alone actual stem cells, but who knows.
It’s hard to say if the torrent of ads and questionable offerings of stem cell clinics and suppliers will be reduced given actions by various regulators and lawsuits against clinic-related firms, but a lot is happening now that could put a large dent in the overall unproven stem cell clinic industry.