Stem-Cell Company Takes Steps Towards Compliance
October 04, 2012
Laboratories that offer stem-cell treatments have come under close scrutiny by FDA. A recent court ruling clarified that stem-cell products that have been more than minimally manipulated can be regulated as drugs, and FDA can require both an IND and manufacture under GMP for such products. Texas-based Celltex Therapeutics, a company that isolates and expands adipose-derived mesenchymal stem cells, ran into trouble with FDA earlier this year over its stem-cell products.