A Phase II Clinical Trial to Evaluate the Safety and Efficacy of ALLO-ASC-DFU for Second Deep Degree Burn Injury Subjects: Controlled, Parallel, Multicenter

Anterogen Co., Ltd.1 site in 1 country20 target enrollmentDecember 23, 2015

ConditionsBurn Injury

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Burn Injury
Sponsor: Anterogen Co., Ltd.
Enrollment: 20
Locations: 1
Primary Endpoint: Time of re-epithelialization
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 23, 2015

End Date

July 13, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Anterogen Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is 18 years of age and older.
•Subjects who have deep second-degree burn wound ≥100cm\^
•TBSA(Total burn surface area) ≤ 30%
•Negative for Urine beta-HCG for women of childbearing age.
•Subject is able to give written informed consent prior to study start and comply with the study requirements.

Exclusion Criteria

•Subject who have been enrolled in another clinical study within 30 days of screening.
•Subjects who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.
•Subjects who are receiving steroids, immunosuppressive, or anticoagulant for long term
•Subjects with active infection.
•Subjects with hemorrhagic and hemocoagulative disease.
•Subjects who are unwilling to use an "effective" method of contraception during the study.
•Subjects who have a history of malignant tumor within the last five years, or is currently undergoing.
•Subjects who are pregnant or breast-feeding.
•Subjects who are considered to have a significant disease which can impact the wound healing by the investigator
•Burn wound is present on any part of the face.