Amplification of Autologous Epidermal Cells to Repair Large Area Deep Wounds
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yicheng Ma
- Phone Number: 15185903573
- Email: 15185903573@163.com
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China
- Recruiting
- Yicheng Ma
-
Contact:
- Yicheng Ma
- Phone Number: 15185903573
- Email: 15185903573@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with a body surface wound of 30% TBSA or more and requiring at least 2 weeks to repair
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 weeks
|
|
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.
|
week 52 after applying CEA
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AOAECTRLADW
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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