Actively Recruiting
Amplification of Autologous Epidermal Cells to Repair Large Area Deep Wounds
Led by Yicheng Ma · Updated on 2025-04-11
100
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying autologous epidermal cell transplantation to help repair large, deep wounds caused by severe burns. This approach addresses the challenge of limited normal skin available for grafting in patients with extensive burns. Traditional skin grafting methods require multiple procedures and have limited expansion, leading to longer healing times and increased scarring. This research evaluates a new technique that expands a small piece of a patient's own skin cells in the lab to create larger grafts for wound repair, aiming to improve healing and reduce complications. The treatment involves taking small pieces of the patient's skin and rapidly growing the epidermal cells in the lab by 1000 to 5000 times over 2 to 3 weeks. These cultured epidermal cell membranes are then combined with expanded or allogeneic dermis grafts to cover large wounds. This method aims to shorten the time for graft integration, increase survival of the grafts, and reduce scarring. It offers a potential solution for patients with limited skin available for traditional grafts, especially those with very large and deep burns. Participants will be patients with wounds covering 30% or more of their body surface area that require at least two weeks to heal. Researchers will evaluate the success of the grafts by measuring the take rate of the cultured epidermal autografts after 4 weeks and monitor for any serious adverse events up to 52 weeks after treatment. The study involves careful monitoring of wound healing, safety, and long-term outcomes to assess this innovative skin repair method. Total participation duration and follow-up details are based on these outcome timelines.
CONDITIONS
Brief Title
Amplification of Autologous Epidermal Cells to Repair Large Area Deep Wounds
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a body surface trauma of 30% TBSA or more
- Wounds requiring at least 2 weeks to repair as assessed by a clinician
You will not qualify if you...
- Patient body surface trauma area less than 30% TBSA
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 2 weeks or until wound repair is achieved
Participants receive cultured autologous epidermal cell membrane transplantation to repair large area deep wounds.
1 treatment visit followed by multiple visits to monitor wound repair
Duration - Up to 52 weeks after applying the cultured epidermal autograft
Participants are monitored for wound healing success and any serious adverse events after treatment.
Periodic visits up to 52 weeks post-treatment
Trial Site Locations
Total: 1 location
1
Yicheng Ma
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Y
Yicheng Ma
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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