A Clinical Trial to Evaluate the Safety and Efficacy of ALLO-ASC-DFU for Second Deep Degree Burn Injury Subjects

Study Overview
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Brief Summary
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This clinical trial is a Phase II controlled, parallel, open-label trial, designed to test the efficacy and safety of ALLO-ASC-DFU and conventional therapy in Deep Second-degree burn wound subjects.

Detailed Description
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ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating Deep Second-degree burn wounds.

Official Title
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A Phase II Clinical Trial to Evaluate the Safety and Efficacy of ALLO-ASC-DFU for Second Deep Degree Burn Injury Subjects: Controlled, Parallel, Multicenter

Conditions
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Burn Injury

Intervention / Treatment
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* Biological: ALLO-ASC-DFU
* Device: Conventional Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 years of age and older. Subjects who have deep second-degree burn wound ≥100cm^2. TBSA(Total burn surface area) ≤ 30% Negative for Urine beta-HCG for women of childbearing age. Subject is able to give written informed consent prior to study start and comply with the study requirements. Exclusion Criteria: Subject who have been enrolled in another clinical study within 30 days of screening. Subjects who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue. Subjects who are receiving steroids, immunosuppressive, or anticoagulant for long term Subjects with active infection. Subjects with hemorrhagic and hemocoagulative disease. Subjects who are unwilling to use an effective method of contraception during the study. Subjects who have a history of malignant tumor within the last five years, or is currently undergoing. Subjects who are pregnant or breast-feeding. Subjects who are considered to have a significant disease which can impact the wound healing by the investigator Burn wound is present on any part of the face. Subjects who are considered not suitable for the study by the investigator. Subjects who are not able to understand the objective of this study or to comply with the study requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALLO-ASC-DFU<br>Allogeneic mesenchymal stem cells | Biological: ALLO-ASC-DFU<br>* Dressing for Second Deep degree Burn injury<br>* Other names: Allogeneic mesenchymal stem cells;|
| Active Comparator: Conventional Therapy<br>Typical therapy conducted for burn injury patients | Device: Conventional Therapy<br>* Typical therapy conducted for burn injury patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of re-epithelialization | Time of re-epithelialization | Follow up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (laboratory tests and adverse events) | Clinically measured abnormality of laboratory tests and adverse events | Follow up to 12 weeks | 
| Burn Scar Index | Vancouver Burn Scar Scale | Follow up to 12 weeks | 
| healing status of the wound evidenced by photography | healing status of the wound evidenced by photography | follow up to 12 weeks |