Burn
Conditions
Keywords
Deep Second-Degree Burn Wound
Brief summary
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.
Interventions
BIOLOGICALALLO-ASC-DFU
Dressing for second-degree burn wound.
Sponsors
Anterogen Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 ≥100 cm\^2. 3. Negative for urine beta-HCG for women of childbearing age. 4. Subject is able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion criteria
1. Subjects 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. 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 study by the investigator 10. Burn wound is present on any part of the face. 11. Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma site). 12. Subjects who are considered not suitable for the study by the investigator. 13. 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 |
|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | up to 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach re-epithelialization of wound | 1, 2, 4 weeks | Evaluation of the improvement of wound measured by time to reach re-epithelialization of wound |
| Vancouver Burn Scar Scale | 4 weeks | — |
Countries
South Korea
Outcome results
None listed