Infections from unapproved stem cell products hospitalize 12

Twelve people in three states developed infections and were hospitalized after they got infusions or injections of stem cell products derived from umbilical cord blood that were contaminated with bacteria, according to a report published Thursday by the US Centers for Disease Control and Prevention.

The patients in Arizona, Florida and Texas received stem cell products processed by Genetech Inc. and distributed by Liveyon LLC, the report says, adding that the products are not FDA-approved or lawfully marketed.

The FDA sent a warning letter to San Diego-based Genetechgtx_ads_conf.ads["ad-manager-209287"]= {"custom_css":"","ad_details":[{"min_width":"","max_width":"","dfp_ad_sizes":[{"dfp_ad_width":"300","dfp_ad_height":"250"}]}],"ad_id":209287,"ad_container":"div-ad-manager-209287","ad_placement":"in-article","ad_name":"ad-manager-209287","position":"in_article","article_position":1};

The CDC noted that stem cell clinics typically work in an outpatient setting, “which often have less robust oversight of infection control measures,” and that’s in part why the FDA recommends that patients avoid getting these treatments outside controlled clinical studies that will ensure that the appropriate manufacturing and safety reporting procedures were followed.

The CDC is still trying to determine whether other patients received the tainted product. Perkins credited the health departments in Texas and Florida with picking up on infections quickly.

The FDA urges health care professionals and consumers to report any adverse events related to treatments with Liveyon products, Genetech products or other stem cell treatments to its MedWatch Adverse Event Reporting program.

Gottlieb noted that the field is growing quickly. There’s a lot of innovation and promise, and some companies have come in to work with the FDA, but others have “ignored our request for dialogue,” he said, and are “putting patients at risk.”

He said Thursday that dozens of firms are not taking the necessary steps to ensure patient safety.