A randomized, controlled clinical trial of autologous stromal vascular fraction cells transplantation to promote mechanical stretch-induced skin regeneration.

摘要: The regeneration response of the skin to mechanical stretching in vivo has been explored reconstructive surgery repair large-scale deformities. ability regenerate limits outcome. Here, we propose an approach which autologous stromal vascular fraction (SVF) cells and are combined overcome this limitation promote regeneration. This randomized, blinded, placebo-controlled clinical trial screened 22 participants undergoing tissue expansion with exhausted Twenty eligible received intradermal injections SVF or placebo treatments. Follow-ups were conducted at 4, 8, 12 weeks assess efficacy 2 years safety. primary endpoint was expanded thickness 12 weeks. secondary endpoints included 4 8 weeks, index (EI), texture score group significantly higher than that control both 8 weeks (mean difference 0.78 [95% CI − 1.43 − 0.11]; p = 0.018) (0.65 − 1.30 − 0.01]; p = 0.046). In group, increase significant 4 weeks (0.49 − 0.80 − 0.06]; p = 0.010) (0.45 − 0.92 0.02]; p = 0.026) maintained after 12 weeks, whereas reduced (0.42 − 0.07 0.91]; p = 0.037). showed greater EI increases (0.50 − 0.00 0.99]; p = 0.047). scores those Histologically, SVF-treated more proliferating blood vessels, extracellular matrix volume increased. No severe adverse events occurred. Transplantation can expedite potency stretch-induced provide reconstruction plentiful tissue. registered Chinese Clinical Trial Registry, ChiCTR2000039317 (registered 23 October 2020—retrospectively registered).