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CDC Finds 12 People Sickened by Stem Cell Provider

Blood sample tubes

(CDC.gov)

23 Dec. 2018. Following up on our story in Science & Enterprise on Thursday, Centers for Disease Control and Prevention, or CDC, issued a report on a provider of stem cell therapies indicating 12 people in 3 states were infected with bacteria from that company’s treatments. CDC issued its reported the next day, 21 December.

Last Thursday, the U.S. Food and Drug Administration took action against the company GeneTech in San Diego, a provider of stem cell treatments from umbilical cord blood. The agency sent a warning letter to GeneTech, citing the company for 19 different violations that range from marketing unapproved treatments and misrepresenting health claims to not meeting specified biological product manufacturing standards. In October, after an inspection by FDA, GeneTech and its distributor Liveyon LLC in Irvine, California recalled products in one of GeneTech’s cord blood stem cell lines.

The CDC’s report indicates 12 patients in Texas, Florida, and Arizona reported infections from GeneTech’s products, and distributed by Liveyon to stem cell clinics. The findings show blood stream infections from Enterobacter cloacae and Citrobacter freundii bacteria were found, while Escherichia coliEnterococcus faecalis, and Proteus mirabilis infections in patient’s joints were also discovered. The report points out that FDA approved umbilical cord stem cells only for specific blood and immune system regeneration therapies.

The CDC report authors also say …

[M]any companies, clinics, and clinicians continue to market products from various sources as treatment for orthopedic, neurologic, and rheumatologic conditions without FDA approval. Such clinics and providers operate in outpatient settings, which often have less robust oversight of infection control measures, including injection safety and medication preparation, potentially amplifying risk to patients.

Many of today’s advances in regenerative medicine are based on stem cells, derived in many cases from an individual’s own precursor cells in bone marrow, body fat, or skin. But as we’ve also reported in Science & Enterprise, many unlicensed or loosely-regulated clinics promising miracle results from stem cell treatments popped up around the country, and even market their services through the U.S. government’s clinical trials database and use crowdfunding sites like GoFundMe to finance their work.

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