Fibrocell Science, a biotechnology company, develops cell therapies for aesthetic, medical and scientific applications. They enrolled participants in their histology study of azficel-T, an autologous cell therapy.

Azficel-T is under review by the FDA for the treatment of moderate to severe nasolabial fold wrinkles. The histology study, requested by the FDA evaluates tissue treated with azficel-T compared to tissue treated with sterile saline placebo.

The company says there are 29 participants in the study. The study will also provide information about the skin after treatment, including evaluation of collagen and elastin fibrils, and cellular structure of the sampled tissues.

“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.”
- David Pernock, Chairman and CEO, Fibrocell Science Inc.

The FDA has six months to review the data submission once they deem Fibrocell’s response to their letter complete.

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