An autologous cell therapy, azficel-T is currently under review by the FDA for the treatment of moderate to severe nasolabial fold wrinkles. The histology study was requested by the FDA in a complete response letter.
Fibrocell said that the histology study is assessing tissue treated with azficel-T as compared to tissue treated with sterile saline (placebo) in 29 participants, with a target evaluable population of 20 participants.
The study is also expected to also provide information about the skin after treatment, including evaluation of collagen and elastin fibrils, and cellular structure of the sampled tissues.
David Pernock, chairman and CEO of Fibrocell Science, said: “The study enrollment progressed well and we are on track to complete the study and submit data to the FDA in the fourth quarter of 2010.”