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

Anterogen

Status and phase: Completed; Phase 1

Conditions: Burn

Treatments: Biological: ALLO-ASC-DFU

Study type: Interventional

Funder types: Industry

Identifiers

NCT02394873

ALLO-ASC-BI-101

Details and patient eligibility

About

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.

Enrollment: 5 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 ≥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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

ALLO-ASC-DFU

Experimental group

Treatment:

Biological: ALLO-ASC-DFU