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Amplification of Autologous Epidermal Cells to Repair Large Area Deep Wounds

Amplification of Autologous Epidermal Cells to Repair Large Area Deep Wounds

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05882110
Enrollment
100
Registered
2023-05-31
Start date
2023-10-01
Completion date
2026-12-31
Last updated
2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autologous Epidermal Cell Transplantation

Keywords

autologous, epidermal cell, transplantation, amplification, deep wounds

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.

Interventions

PROCEDURECultured 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.

Sponsors

Yicheng Ma
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Take rate of cultured epidermal autograft4 weeksThe take rates of CEA(cultured epidermal autograft) were calculated separately for every graft site according to the anatomical regions.
The incidence of serious adverse eventsweek 52 after applying CEAThe safety of CEA(cultured epidermal autograft) is evaluated using the incidence of serious adverse events, such as tumorous conditions, allergic reactions, or critical infections.

Countries

China

Contacts

Primary ContactYicheng Ma
15185903573@163.com15185903573

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026