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

NCT07114692 | Not Yet Recruiting DMC

• 1 other identifier: Shanghai9th-SVF-ES-RCT
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

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, 4 and 8 weeks after intervention

Secondary Outcomes (1)

• Skin surface area

  baseline, 4 and 8 weeks after intervention

Other Outcomes (2)

• Skin texture

  Baseline, 4 and 8 weeks after intervention

• Skin perfusion

  Baseline, 4 and 8 weeks after intervention

Study Arms (2)

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. 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: Stromal vascular fraction transplantation

Normal saline injection

PLACEBO COMPARATOR

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.

Biological: Normal saline injection

Interventions

Stromal vascular fraction transplantation BIOLOGICAL

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.

Stromal vascular fraction transplantation

Normal saline injection BIOLOGICAL

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.

Normal saline injection

Eligibility Criteria

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

You may qualify if:

• Age: over 18 years and under 65 years;
• show signs of deterioration of skin texture during expansion, including stretch marks or thinning of the dermis;
• Have signed the informed consent form, agree to participate in this study, and are able to comply with follow-up requirements.

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

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Tao Zan, M.D., Ph.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohan Lin

CONTACT

(021)23271699; shjyiec@163.com

Xin Huang, M.D., Ph.D.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of the Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, SJTUSM

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share