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

Phase 2

Completed

• Conditions: Burn Injury
• Interventions: Device: Conventional Therapy; Biological: ALLO-ASC-DFU

• Registration Number: NCT02619851
• Lead Sponsor: Anterogen Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-02
• Study Start: 2015-12-23
• Primary Completion: 2019-07-02
• Study Completion: 2021-07-13
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Therapy	Conventional Therapy	Typical therapy conducted for burn injury patients
ALLO-ASC-DFU	ALLO-ASC-DFU	Allogeneic mesenchymal stem cells

Primary Outcome Measures

Name	Time	Method
Time of re-epithelialization	Follow up to 12 weeks	Time of re-epithelialization

Secondary Outcome Measures

Name	Time	Method
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
Safety (laboratory tests and adverse events)	Follow up to 12 weeks	Clinically measured abnormality of laboratory tests and adverse events

Trial Locations

Locations (1)

Hallym university Medical Center; 🇰🇷 Seoul, Korea, Republic of