BioCentury
ARTICLE | Company News

Celltex gene/cell therapy news

October 8, 2012 7:00 AM UTC

Celltex said it received a letter from FDA last month indicating that the process the company uses to multiply adult stem cells is subject to FDA regulation as biological drug manufacturing. The company, which supplies physicians with adipose-derived mesenchymal stem cells for autologous use as a clinical therapy, claims it makes identical copies of an individual's own stem cells and therefore should not be subject to FDA drug regulations. Celltex said it disagrees with FDA and plans to contest the opinion within the agency's procedures. ...