Amplification of Autologous Epidermal Cells to Repair Large Area Deep Wounds

Not Applicable

Recruiting

• Conditions: Autologous Epidermal Cell Transplantation
• Interventions: Procedure: Cultured autologous epidermal cell membrane

• Registration Number: NCT05882110
• Lead Sponsor: Yicheng Ma

Brief Summary

Autologous epidermal cell transplantation is based on the principle and technology of skin tissue engineering, and is performed by cutting small pieces of autologous skin from patients, isolating and culturing and expanding them, and then transplanting them to the patient's wounds to repair the damage.

Detailed Description

Timely wound repair has been a great challenge in the treatment of patients with large deep burns. The current conventional approach is to use autologous skin grafts, such as micro-skin grafts, stamp skin grafts, and mesh skin grafts. Since there is very little normal skin left after large deep burns and the expansion of autologous skin grafts is limited (3-15 times), repeated skin grafting procedures are needed to repair the wound gradually, resulting in a long course of disease, scar growth and contracture, which seriously affects the quality of survival and even endangers life. Especially for patients with very large deep burns, there is an extreme shortage of normal skin sources, so they face the dilemma of having no rice to cook and unable to repair their wounds.

Based on the principle and technology of skin tissue engineering, autologous epidermal cell transplantation can provide sufficient skin source for patients with large deep burns by cutting very small pieces of autologous skin (about 2-10 cm2) and expanding them by 1000-5000 times after 2-3 weeks of in vitro culture. Autologous epidermal cell membranes combined with a large proportion of expanded autologous dermis (e.g. stamp skin, reticular skin) can significantly shorten the interstitial fusion time, improve the survival rate of autologous dermis transplants, and reduce scar growth after wound healing; autologous epidermal cell membranes combined with allogeneic dermis transplants can repair third-degree burn wounds, thus providing a large number of dermis sources for patients with lack of dermis sources, and has become an important treatment tool for saving the lives of patients with large deep burns. It has become an important treatment tool to save the lives of patients with large deep burns.

Study Timeline

• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-21
• Study First Posted: 2023-05-31
• Study Start: 2023-10-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-10-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with a body surface trauma of 30% TBSA or more and a wound that requires at least 2 weeks to repair as assessed by the clinician

Exclusion Criteria

• Patient body surface trauma area less than 30% TBSA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with a body surface wound of 30% TBSA or more and requiring at least 2 weeks to repair	Cultured autologous epidermal cell membrane	-

Primary Outcome Measures

Name	Time	Method
The incidence of serious adverse events	week 52 after applying CEA	The safety of CEA(cultured epidermal autograft) is evaluated using the incidence of serious adverse events, such as tumorous conditions, allergic reactions, or critical infections.
Take rate of cultured epidermal autograft	4 weeks	The take rates of CEA(cultured epidermal autograft) were calculated separately for every graft site according to the anatomical regions.

Trial Locations

Locations (1)

Yicheng Ma; 🇨🇳 Shanghai, Shanghai, China