NCT06439459

Skin Dermal Regeneration After Stromal Vascular Fraction Transplantation

Quantitative Measurements of the Skin Dermal Regeneration After Stromal Vascular Fraction Transplantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, exploratory investigation aimed at exploring the efficacy of 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, Doppler ultrasound, VISIA skin analyzer, CK skin analyzer, and indocyanine green angiography.

Detailed description

This study is a prospective, exploratory investigation aimed at exploring the efficacy of 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, Doppler ultrasound, VISIA skin analyzer, CK skin analyzer, and indocyanine green angiography. The trial aims to include patients experiencing dermal exhaustion during the process of skin soft tissue expansion. We will extract SVF components from autologous adipose tissue and injected intradermally into the expanded skin. The changes of dermis of expanded skin were recorded before the treatment (baseline), and at 4 weeks and 8 weeks follow-up timepoints after SVF transplantation. More specifically, skin surface area was measured using laser 3D scan; skin thickness and texture were detected by Doppler ultrasound, VISIA skin analyzer and CK skin analyzer; skin blood perfusion was analyzed using indocyanine green angiography.

Conditions

• Skin Regeneration

Interventions

Type	Name	Description
PROCEDURE	Stromal vascular fraction transplantation	Stromal vascular fraction was extracted from subcutaneous fat harvested from either the abdomen or the posterior inner thigh region. The SVF cell-pellet was washed and was adjusted to 2×10\^6 cells/mL. 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. This procedure was repeated until adequate skin area was achieved for subsequent facial restoration surgery.

Timeline

• Start date: 2023-02-15
• Primary completion: 2023-12-21
• Completion: 2024-02-25
• First posted: 2024-06-03
• Last updated: 2024-06-03

Locations

1 site across 1 country: China