A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-BI-101 Clinical Trial

Study Overview
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Brief Summary
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This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial(ALLO-ASC-BI-101) for 23 months.

Detailed Description
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This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-BI-101) for 23 months. 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 a burn.

Official Title
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A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 1 Clinical Trial of ALLO-ASC-BI-101

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: Subjects who are treated with ALLO-ASC-DFU sheet in phase 1 clinical trial of ALLO-ASC-BI-101. A subject who is willing to follow the protocol and provide informed consent on screening, given that the information with respect to the clinical trial is provided. Exclusion Criteria: 1. Subjects who are considered not suitable for the study by the principal investigator. (For example, Subjects requiring surgical procedure on target site)

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ALLO-ASC-DFU treatment<br>Subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial of ALLO-ASC-BI-101 | Biological: ALLO-ASC-DFU<br>* 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 a burn. This tudy is a follow-up study without intervention. Other Names: Allogenic adipose-derived mesenchymal stem cells<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 | Evaluation of AE | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vancouver Burn Scar Scale | Evaluation of Vancouver Burn Scar Scale | Every time of visit for follow up to 24 months | 

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