The GLP is committed to full transparency. Download and review our Annual Report.

Unapproved stem cell treatments draw FDA investigation following bacterial infections

| | January 9, 2019

This year [2018], 12 people have been hospitalized with bacterial infections after being treated with stem cell products derived from umbilical cord blood and manufactured by Genetech, a biotech firm in San Diego and distributed by Liveyon in Irvine, California, according to a Centers for Disease Control and Prevention report out [December 21].

In a November 29 warning letter, the Food and Drug Administration (FDA) listed the many problems it had found during an inspection of Genetech this June and gave the company 15 business days to respond with what it had done to correct the deficiencies.

There are hundreds of stem cell clinics around the country offering services to treat all manner of ailments, though, as Times notes, there’s no proof that they are safe or effective.

Related article:  Gene therapy research gets boost from parent-led crowdfunding

Genetech represents one more case of the federal government taking action against these clinics when it finds their practices are unsafe. In August 2017, the FDA raided a California clinic that was injecting stem cells mixed with smallpox vaccine into patients’ blood and tumors. The agency also sent a warning letter to a Florida clinic that had cleanliness issues and was operating without the necessary license. This October, the Federal Trade Commission took action against two companies engaged in false advertising about the effectiveness of their stem cell treatments.

According to the CDC release, the only FDA-approved stem cell product is umbilical cord blood used for hematopoietic and immunologic reconstitution.

Read full, original post: FDA Cracks Down on Purveyors of Stem Cell Treatments

The GLP aggregated and excerpted this article to reflect the diversity of news, opinion, and analysis. Click the link above to read the full, original article.
News on human & agricultural genetics and biotechnology delivered to your inbox.
Optional. Mail on special occasions.

Send this to a friend