Skin Dermal Regeneration After Stromal Vascular Fraction Transplantation

Not Applicable

Completed

• Conditions: Skin Regeneration
• Interventions: Procedure: Stromal vascular fraction transplantation

• Registration Number: NCT06439459
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief 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.

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-02-15
• Primary Completion: 2023-12-21
• Study Completion: 2024-02-25
• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-05-27
• Last Update Submitted: 2024-05-27
• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• had undergone tissue expansion treatment;
• show signs of deterioration of skin texture during expansion, including stretch marks or thinning of the dermis (<2mm) with no improvement after suspending expansion for 2 weeks;
• require further expansion to achieve the size for defect reconstruction.

Exclusion Criteria

• Patients with serious underlying diseases such as cardiovascular or cerebrovascular disease, peripheral vascular disease, or impaired liver or kidney function;
• Patients with a long history of smoking and alcohol use who have not quit smoking or drinking;
• Patients allergic to iodine or iodine-containing preparations;
• Patients with psychiatric disorders, lack of insight, or those who cannot accurately express themselves or cooperate;
• Patients with contraindications for SVF transplantation, such as ulceration or infection of the expanded skin;
• Patients with severely loose skin or insufficient subcutaneous fat tissue;
• Patients who request to withdraw informed consent and exit the clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stromal vascular fraction transplantation	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. 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.

Primary Outcome Measures

Name	Time	Method
Dermal thickness	Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation	Using Doppler ultrasound to measure the full-thickness of skin dermis of the expanded skin. The measurements were conducted at the center of the expanded skin and other four points (above, below, left, right) around the center. The average value is taken to represent the dermal thickness of the patient's expanded skin.

Secondary Outcome Measures

Name	Time	Method
Skin surface area	Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation	Using the HSCAN771 handheld laser 3D scanner and the VIVID910 3D laser scanning system to measure the surface area of the expanded skin.

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Huangpu, China