Skin Dermal Regeneration After Stromal Vascular Fraction Transplantation

NCT06439459 | Completed DMC

• 3 other identifiers: Shanghai9th-SDR-SVF-ZT22MC1940300shslczdzk00901
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Regeneration

Keywords

skin expansion; stromal vascular fraction

Outcome Measures

Primary Outcomes (1)

• Dermal thickness

  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.

  Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation

Secondary Outcomes (1)

• Skin surface area

  Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation

Other Outcomes (3)

• Skin texture (dermal rupture)

  Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation

• Skin texture (elasticity)

  Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation

• Skin perfusion

  Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation

Study Arms (1)

Stromal vascular fraction transplantation

EXPERIMENTAL

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.

Procedure: Stromal vascular fraction transplantation

Interventions

Stromal vascular fraction transplantation PROCEDURE

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.

Stromal vascular fraction transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Huangpu, 200011, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 3, 2024
• Study Start: February 15, 2023
• Primary Completion: December 21, 2023
• Study Completion: February 25, 2024
• Last Updated: June 3, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)