20
Participants
Start Date
September 1, 2025
Primary Completion Date
September 1, 2027
Study Completion Date
December 1, 2027
Stromal vascular fraction transplantation
Subcutaneous fat was harvested from either the abdomen or the posterior inner thigh region and then digested with 600 U of collagenase (Shanghai Qiaoyuan Biological Pharmaceutical Co., Ltd, Shanghai, China) at 37°C and 150rpm for three hours. After enzymatic digestion, the lower aqueous phase liquid was aspirated to acquire the stromal vascular fraction (SVF). The SVF cell-pellet was washed and adjusted to 2×10\^6 cells/mL. Lidocaine cream will be applied to the expanded skin to achieve surface anesthesia. The skin was marked with methylene blue and a total of 0.5ml (around 1×10\^6 cells) were transplanted intradermally at the center of each 2cm×2cm squares. The expander was inflated two times a week using constant pressure inflation method, where the intracapsular pressure was monitored using a pressure meter and the inflation was halted when the pressure reached 100 mmHg.
Normal saline injection
Lidocaine cream will be applied to the expanded skin to achieve surface anesthesia. The skin was marked with methylene blue and a total of 0.5ml 0.9% normal saline were transplanted intradermally at the center of each 2cm×2cm squares. The expander was inflated two times a week using constant pressure inflation method, where the intracapsular pressure was monitored using a pressure meter and the inflation was halted when the pressure reached 100 mmHg.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER