Yicheng Ma
Shanghai, Shanghai Municipality, China
Location status: Recruiting
Recruiting
NCT Number: NCT05882110
Amplification of Autologous Epidermal Cells to Repair Large Area Deep Wounds
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Cultured autologous epidermal cell membrane
ProcedureThe 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.
Primary outcomes
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Take rate of cultured epidermal autograft
Time frame: 4 weeks
The take rates of CEA(cultured epidermal autograft) were calculated separately for every graft site according to the anatomical regions.
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The incidence of serious adverse events
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Yicheng Ma
Other
Registry information
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 31, 2023
- Registry last updated
- Apr 11, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.