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Infections put 12 people in hospitals after they received unapproved stem cell products
Source: CNN
Infections put 12 people in hospitals after they received unapproved stem cell products
By Jen Christensen, CNN
Updated 1846 GMT (0246 HKT) December 20, 2018
(CNN) — 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 Genetech in November about ReGen5, ReGen10 and ReGen30 for allogeneic use. The agency issued a statement about it Thursday and said it was sending letters to 20 other providers of stem cell treatments, reminding them of the agency's rules about regenerative medicine.
"We see a lot of promise from stem cell treatments, but we also have a lot of concern, and we started by sending these 20 letters singling out these firms that should be engaging with FDA but haven't been," FDA Commissioner Dr. Scott Gottlieb said.
-snip-
By Jen Christensen, CNN
Updated 1846 GMT (0246 HKT) December 20, 2018
(CNN) — 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 Genetech in November about ReGen5, ReGen10 and ReGen30 for allogeneic use. The agency issued a statement about it Thursday and said it was sending letters to 20 other providers of stem cell treatments, reminding them of the agency's rules about regenerative medicine.
"We see a lot of promise from stem cell treatments, but we also have a lot of concern, and we started by sending these 20 letters singling out these firms that should be engaging with FDA but haven't been," FDA Commissioner Dr. Scott Gottlieb said.
-snip-
Read more: https://edition.cnn.com/2018/12/20/health/infections-from-stem-cell-products/index.html
