Clinical trial of autologous differentiated adipocytes from stem cells derived from human adipose tissue

BACKGROUND: Adipose tissue-derived stem cells (ASCs) are considered to be a reliable cell source for the generation of adipose tissue because they can be differentiated into adipocytes. Previous data have indicated that adipogenic differentiation of ASCs before transplantation can enhance the regeneration of adipose tissue. OBJECTIVE: To evaluate the efficacy and safety of the use of autologous differentiated adipocytes for the treatment of depressed scars. METHODS: Autologous differentiated adipocytes were produced using well-established techniques, including the harvesting of stromal vascular fraction cells from lipoaspirates, expansion of ASCs, and differentiation into adipocytes. This was an open-label, dose-escalation study. Patients were given a subcutaneous injection of differentiated adipocytes and followed for 12 weeks. RESULTS: Thirty-one patients were injected with differentiated adipocytes. When the differentiated adipocytes were injected subcutaneously into depressed scars, the average recovery in volume was 74.6% at 12 weeks. Of 17 patients who completed the follow-up after determination of dose, seven were willing to enroll for extended follow-up. Long-term follow-up revealed that the recovery in volume at 12 weeks was maintained well for at least 1 year. There were no significant adverse events. CONCLUSIONS: The use of autologous differentiated adipocytes can be a safe and effective treatment for soft tissue defects, with relatively long-term maintenance of volume.