Approach extended in vivo skin regeneration by combining autologous stem cell transplantation and mechanical stretch: A Phase I/II Clinical Trial
Shuang-Bai Zhou, M.D., Ph.D., Tao Zan, M.D., Ph.D., Guo-You Zhang, M.D., Ph.D., Yun Xie, M.D., Cheng-An Chiang, M.D., Yao-Kai Gan, M.D., Ph.D., Jing Wang, M.D., Kai Liu, M.D., Ph.D., Bin Gu, M.D., Mei Yang, M.D., Ph.D., Qing-Feng Li, M.D., Ph.D..
Shanghai Jiao Tong University, Shanghai Ninth People's Hospital, Shanghai, China.
Purpose Mechanical stretch can induce effective but limited in vivo skin regeneration. Adult stem cells may be a hint to promote tissue regeneration. In this trial, we combined the stem cells with in vivo microenvironment of mechanical stretch to create an innovative strategy of approaching autologous regenerated skin.
Methods In this double-blinded, randomized, controlled clinical trial, 42 patients (aged 18-60 years) who presented with deteriorated expanded skin were recruited. The patients were randomly assigned to receive intradermal autologous bone marrow mononuclear cells (MNCs) transplantation or placebo injections. The primary endpoint was the absolute change in skin expansion, which was expressed as the expansion index (EI) at 4 and 8 weeks post-treatment. The secondary end points were assessed at 4 and 8 weeks including the thickness, the area and the texture of expanded skin.
Results Compared with the Control group, the MNC group had a significantly higher EI at both 4 weeks (p=0.039) and 8 weeks (p=0.001), which indicated accelerated regeneration after stem cell transplantation. Similar improvements were observed for the skin thickness and the expanded skin area (p<0.001) at 8 weeks. A higher score for the expanded skin texture was found in the MNC group with the control group. No severe adverse event related to MNC transplantation occurred.
Conclusions Intradermal transplantation of autologous stem cells may be safe and effective for promoting mechanical stretch induced skin regeneration, providing a new approach to obtaining more autologous regenerated skin by combining stem cell treatment with special microenvironment.
Back to 2015 Annual Meeting Program