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NOT YET RECRUITING
NCT07114692
NA

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

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

View on ClinicalTrials.gov

Summary

This study is a randomized controlled trial aimed at evaluating the effect of intradermal stromal vascular fraction (SVF) transplantation in treating exhaustion of dermal regenerative capacity during skin expansion. The dermal thickness, texture, and perfusion before and after SVF transplantation would be recorded and analyzed by a series of quantitative devices including laser 3D scanner, ultrasound, VISIA skin analyzer, CK skin analyzer, and indocyanine green angiography.

Official title: The Effect of Intradermal Stromal Vascular Fraction Transplantation on the Regeneration of Expanded Skin: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-09-01

Completion Date

2027-12-01

Last Updated

2025-08-17

Healthy Volunteers

No

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.