Liveyon is a cord blood product marketer that distributed a batch of cells a couple of years back that led to many patients being hospitalized with infections. Some had sepsis and ended up in the ICU. It was thought at the time that about a dozen patients who had been injected with the Liveyon product had been sickened.
The number was actually much higher it seems, based on a new report.
Liveyon cord product sickened many more people
The new epidemiological study in JAMA Network Open reports on a number of aspects of the large adverse event.
The paper is entitled Investigation of Bacterial Infections Among Patients Treated With Umbilical Cord Blood–Derived Products Marketed as Stem Cell Therapies by Hartnett, et al. They found that 20 patients in 8 states got bacterial infections after injections with the product. Strikingly, 19 out of these 20 patients required hospitalization.
The CDC team also used next-gen sequencing to determine that all of the contamination likely originated from one source. As to the specific pathogens they write, “The most frequently isolated bacteria from patients with infections were common enteric species, including Escherichia coli (14 patients) and Enterobacter cloacae (7 patients). ”
About those unopened vials
The researchers also had access to many unopened vials of the Liveyon product and examined those for contamination as well. They report:
Of unopened, undistributed products sampled for testing, 65% (22 of 34 vials) were contaminated with at least 1 of 16 bacterial species, mostly enteric.
Imagine if dozens of more patients had been injected with those 34 vials.
How did things get to the point where it could put so many people at potential risk? What about the FDA or other agencies proactively stopping such marketing of risky and unproven cell products? Are there other similar companies still operating in the U.S. even now?
FDA action in the cord space
I’ve had growing concern over the last 4-5 years about perinatal tissue and cell suppliers like Liveyon.
Several other firms seem to be actively supplying materials to customers. In June the FDA warned Utah Cord Bank related to manufacturing issues. Concerningly, one of the issues noted by the agency was ” You failed to validate your microbiological testing.”
Just over a year ago another supplier, Predictive Technology, also got a warning letter.
Another issue raised in their warning letter that applies more broadly in some cases is that umbilical cord cell products are defined as drugs by the FDA. In order to market them in a compliant way you must have prior FDA approval. I’m not aware of firms in this space having such approval at this time.
My guess is that FDA is keeping very close tabs on the perinatal space these days.
What does the future hold for Liveyon?
At present I wasn’t able to determine the current status of Liveyon as a company.
Its leader John Kosolcharoen is still listed as CEO of the company on LinkedIn. The most recent email I sent to Kosolcharoen some months back did not receive a reply.
Another LinkedIn search by the Liveyon company name found many apparent employees so maybe they are still active in the umbilical cord space? Perhaps some of this is going on outside the U.S.? What about in our country?