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

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

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.

Study Overview

• Status: Completed
• Conditions: Burn Injury
• Intervention / Treatment: Biological: ALLO-ASC-DFU; Device: Conventional Therapy

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Hallym University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALLO-ASC-DFU; Allogeneic mesenchymal stem cells	Biological: ALLO-ASC-DFU; Dressing for Second Deep degree Burn injury; Other Names: Allogeneic mesenchymal stem cells
Active Comparator: Conventional Therapy; Typical therapy conducted for burn injury patients	Device: Conventional Therapy; Typical therapy conducted for burn injury patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of re-epithelialization	Time of re-epithelialization	Follow up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (laboratory tests and adverse events)	Clinically measured abnormality of laboratory tests and adverse events	Follow up to 12 weeks
Burn Scar Index	Vancouver Burn Scar Scale	Follow up to 12 weeks
healing status of the wound evidenced by photography	healing status of the wound evidenced by photography	follow up to 12 weeks

Collaborators and Investigators

• Sponsor: Anterogen Co., Ltd.
• Investigators: Principal Investigator: Wook Chun, MD, PhD, Hallym University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2015
• Primary Completion (Actual): July 2, 2019
• Study Completion (Actual): July 13, 2021

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: December 1, 2015
• First Posted (Estimated): December 2, 2015

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Burns; Wounds and Injuries
• Other Study ID Numbers: ALLO-ASC-BI-201