Clinical Safety of Stromal Vascular Fraction Separation at the Point of Care.

ABSTRACT

INTRODUCTION: Pluripotential cells in adipose tissue may be important in long-term volume retention and regenerative effects of fat grafting. Unfortunately, graft harvest with lipoaspiration significantly depletes the population of stromal vascular cells, which includes adipose stem cells. Stromal vascular fraction (SVF) cells may be isolated from excess lipoaspirate at the point of care and used to replenish fat grafts, a technique termed cell-assisted lipotransfer (CAL). Preclinical and clinical evidence supports the rationale of CAL but clinical adoption of the strategy requires evidence of clinical safety. This prospective, level 1 study reports clinical safety of SVF-enhanced fat grafting using a manual, collagenase-based separation process to isolate autogenous progenitor cells from lipoaspirate at the point of care. METHODS: One hundred sixty-four subjects underwent 174 SVF-enhanced autologous fat grafting procedures at the university stem cell center between August 2009 and November 2014 for a variety of cosmetic and reconstructive indications. RESULTS: Cell-assisted lipotransfer was performed for a variety of cosmetic and reconstructive indications. The mean time of the SVF isolation process was 91 minutes. Because of the frequent concomitant procedures, the average operating room time increased by only 11 minutes. Mean follow-up was 19.9 months. There were no major complications and 6 minor complications. No collagenase or neutral protease related complications were observed. CONCLUSIONS: This series of 174 CAL cases demonstrates that SVF cell isolation using a standardized, manual, collagenase-based process at the POC is equivalent in safety compared to nonenhanced fat grafting. These results support expanded use of CAL in the clinical research setting.