Autologous Stem Cell Transplantation Promotes Mechanical Stretch Induced Skin Regeneration: A Randomized Phase I/II Clinical Trial

AbstractBackgroundMechanical stretch, in term of skin expansion, can induce effective but limited in vivo skin regeneration for complex skin defect reconstruction. We propose a strategy to obtain regenerated skin by combining autologous stem cell transplantation with mechanical stretch.MethodsThis randomized, blinded placebo-controlled trial enrolled 38 adult patients undergoing skin expansion presenting with signs of exhausted regenerative capacity. Patients randomly received autologous bone marrow mononuclear cell (MNC) or placebo injections intradermally. Follow-up examinations were at 4, 8weeks and 2years. The primary endpoint was the volume achieved in relation to the designed size of the expander (expansion index, EI). Secondary endpoints were surface area, thickness and texture of expanded skin. This trial is registered with ClinicalTrial.gov, NCT01209611.FindingsThe MNC group had a significantly higher EI at 4weeks (mean difference 0.59 [95% CI, 0.03–1.16]; p=0.039) and 8weeks (1.05 [95% CI, 0.45–1.66]; p=0.001) versus controls. At 8weeks, the MNC group had significantly thicker skin (epidermis: p<0.001, dermis: p<0.001) and higher subjective scores for skin quality/texture (24.8 [95% CI, 17.6–32.1]; p<0.001). The MNC group had more skin surface area (70.34cm2 [95% CI, 39.75–100.92]; p