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

Phase 1

Completed

• Conditions: Burn
• Interventions: Biological: ALLO-ASC-DFU

• Registration Number: NCT02394873
• Lead Sponsor: Anterogen Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-20
• Primary Completion: 2015-08
• Study Completion: 2015-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-28
• Last Update Posted: 2015-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALLO-ASC-DFU	ALLO-ASC-DFU	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	up to 4 weeks

Secondary Outcome Measures

Name	Time	Method
Vancouver Burn Scar Scale	4 weeks
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

Trial Locations

Locations (1)

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