Fibroblast Injectable Gets Mixed Panel Review

Voting no on both efficacy and safety, panelist Dr. Lynn A. Drake of Harvard Medical School, Boston, said she was concerned about the lack of nonvisible evidence to support safety. She and other dermatologists on the panel said that it was important to determine whether normal or scar tissue was present after treatment, whether collagen was produced, and if so, what type, and whether elastin was affected.

Dr. Drake questioned whether the lack of efficacy in people over age 65 was indicative of the inability of the elderly to scar, and emphasized that once a new treatment for wrinkles becomes available, it is widely used immediately in all age groups and often in locations where it might not be safe.

If approved, azfibrocel-T would be the first cellular product for treating nasolabial fold wrinkles and the first fibroblast product contained in an injectable cell suspension, according to the FDA. It would be the second autologous cell product to be approved; the first is Carticel, a preparation of autologous chondrocytes used to repair knee cartilage. Clinical studies are underway in facial acne scars, gingival recession, and vocal fold scarring. A study in burn scars is being planned, the company said.

The FDA usually follows the recommendations of its advisory panels.