The US Food and Drug Administration has approved Antria’s Phase 2 clinical trial for the use of autologous adipose-derived stem cells (ADSC) in plastic surgery.
The company will begin the trials in Gainesville, Fla, within the next 90 days.
Antria’s patent-pending process uses liposuction to extract the fat. Within 1 hour, stem cells are prepared from that material. Clinicians then inject the stem cells under the patient’s facial skin to reduce the appearance of wrinkles, scars, and sagging skin. One of the critical components of Antria’s process is to isolate stem cells from adult fat cells using its proprietary Adipolyx™, a collegenase-based reagent.
The Phase 2 will expand the clinical trial to include a much larger group of participants. Antria expects its next clinical trial to use ADSCs for breast-augmentation procedures.