Amplification of Autologous Epidermal Cells to Repair Large Area Deep Wounds

NCT ID: NCT05882110

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2026-12-31

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.

Conditions

Autologous Epidermal Cell Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with a body surface wound of 30% TBSA or more and requiring at least 2 weeks to repair

Group Type: EXPERIMENTAL

Cultured autologous epidermal cell membrane

Intervention Type: PROCEDURE

The cultured autologous epidermal cell membrane is made from the patient's autologous epidermal cells by in vitro rapid expansion and culture technology, which has good biocompatibility, non-toxic, non-teratogenic, can reduce the skin area cut by traditional autologous skin grafting methods, and has high proliferative activity to promote wound repair and regeneration.

Interventions

Cultured autologous epidermal cell membrane

The cultured autologous epidermal cell membrane is made from the patient's autologous epidermal cells by in vitro rapid expansion and culture technology, which has good biocompatibility, non-toxic, non-teratogenic, can reduce the skin area cut by traditional autologous skin grafting methods, and has high proliferative activity to promote wound repair and regeneration.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yicheng Ma

OTHER

Sponsor Role: lead

Responsible Party

Yicheng Ma

Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Yicheng Ma

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yicheng Ma

Role: CONTACT

15185903573@163.com

15185903573

Facility Contacts

Yicheng Ma

Role: primary

15185903573@163.com

15185903573

Other Identifiers

AOAECTRLADW

Identifier Type: -

Identifier Source: org_study_id