Burn Injury
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALALLO-ASC-DFU
Dressing for Second Deep degree Burn injury
DEVICEConventional Therapy
Typical therapy conducted for burn injury patients
Sponsors
Anterogen Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of re-epithelialization | Follow up to 12 weeks | Time of re-epithelialization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety (laboratory tests and adverse events) | Follow up to 12 weeks | Clinically measured abnormality of laboratory tests and adverse events |
| Burn Scar Index | Follow up to 12 weeks | Vancouver Burn Scar Scale |
| healing status of the wound evidenced by photography | follow up to 12 weeks | healing status of the wound evidenced by photography |
Countries
South Korea
Outcome results
None listed