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

Anterogen

Status and phase: Completed; Phase 2

Conditions: Burn Injury

Treatments: Biological: ALLO-ASC-DFU; Device: Conventional Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02619851

ALLO-ASC-BI-201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is 18 years of age and older.
2. Subjects who have deep second-degree burn wound ≥100cm^2.
3. TBSA(Total burn surface area) ≤ 30%
4. Negative for Urine beta-HCG for women of childbearing age.
5. Subject is able to give written informed consent prior to study start and comply with the study requirements.

Exclusion criteria

1. Subject who have been enrolled in another clinical study within 30 days of screening.
2. Subjects who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.
3. Subjects who are receiving steroids, immunosuppressive, or anticoagulant for long term
4. Subjects with active infection.
5. Subjects with hemorrhagic and hemocoagulative disease.
6. Subjects who are unwilling to use an "effective" method of contraception during the study.
7. Subjects who have a history of malignant tumor within the last five years, or is currently undergoing.
8. Subjects who are pregnant or breast-feeding.
9. Subjects who are considered to have a significant disease which can impact the wound healing by the investigator
10. Burn wound is present on any part of the face.
11. Subjects who are considered not suitable for the study by the investigator.
12. Subjects who are not able to understand the objective of this study or to comply with the study requirements

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

ALLO-ASC-DFU

Experimental group

Description:

Allogeneic mesenchymal stem cells

Treatment:

Biological: ALLO-ASC-DFU

Conventional Therapy

Active Comparator group

Description:

Typical therapy conducted for burn injury patients

Treatment:

Device: Conventional Therapy