Fibrocell Science, Inc. (OTC Bulletin Board: FCSC), a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today the completion of enrollment of and first treatment visits for participants in its histology study (IT-H-001) of azficel-T. An autologous cell therapy, azficel-T is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe nasolabial fold wrinkles.
The histology study, requested by the FDA in a Complete Response letter, is evaluating 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 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," said David Pernock, Chairman and CEO, Fibrocell Science Inc.
According to milestones established in the Prescription Drug User Fee Act (PDUFA), the FDA will have six months to review the data submission once they deem Fibrocell's response to their letter complete.
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