The Effect of Stromal Vascular Fraction Transplantation on the Regeneration of Expanded Skin

NANot yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

September 1, 2027

Study Completion Date

December 1, 2027

Conditions
Skin Regeneration
Interventions
BIOLOGICAL

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.

BIOLOGICAL

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.

All Listed Sponsors
lead

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

NCT07114692 - The Effect of Stromal Vascular Fraction Transplantation on the Regeneration of Expanded Skin | Biotech Hunter | Biotech Hunter