A Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Deep Second-degree Burn Wound

Study Overview
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Brief Summary
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This is a phase I study to evaluate the safety of ALLO-ASC-DFU for the treatment of deep second-degree burn wound patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells 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 a burn.

Official Title
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A Phase 1 Clinical Study to Evaluate the Safety of Allogeneic Adipose-derived Stem Cells in the Subjects With Deep Second-degree Burn Wound

Conditions
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Burn

Intervention / Treatment
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* Biological: ALLO-ASC-DFU


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 ≥100 cm^2. Negative for urine beta-HCG for women of childbearing age. Subject is able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: Subjects 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. 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 study by the investigator Burn wound is present on any part of the face. Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma site). 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALLO-ASC-DFU<br> | Biological: ALLO-ASC-DFU<br>* Dressing for second-degree burn wound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach re-epithelialization of wound | Evaluation of the improvement of wound measured by time to reach re-epithelialization of wound | 1, 2, 4 weeks | 
| Vancouver Burn Scar Scale |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Second-Degree Burn Wound