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

Primary Purpose

Burn Injury

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

ALLO-ASC-DFU

Conventional Therapy

About this trial

This is an interventional treatment trial for Burn Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is 18 years of age and older.
Subjects who have deep second-degree burn wound ≥100cm^2.
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.
Subjects who are considered not suitable for the study by the investigator.
Subjects who are not able to understand the objective of this study or to comply with the study requirements

Sites / Locations

Hallym university Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ALLO-ASC-DFU

Conventional Therapy

Arm Description

Allogeneic mesenchymal stem cells

Typical therapy conducted for burn injury patients

Outcomes

Primary Outcome Measures

Time of re-epithelialization

Secondary Outcome Measures

Safety (laboratory tests and adverse events)

Clinically measured abnormality of laboratory tests and adverse events

Burn Scar Index

Vancouver Burn Scar Scale

healing status of the wound evidenced by photography

Full Information

NCT ID

NCT02619851

First Posted

November 30, 2015

Last Updated

August 23, 2023

Sponsor

Anterogen Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02619851

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

December 23, 2015 (Actual)

Primary Completion Date

July 2, 2019 (Actual)

Study Completion Date

July 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anterogen Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burn Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALLO-ASC-DFU

Arm Type

Experimental

Arm Description

Allogeneic mesenchymal stem cells

Arm Title

Conventional Therapy

Arm Type

Active Comparator

Arm Description

Typical therapy conducted for burn injury patients

Intervention Type

Biological

Intervention Name(s)

ALLO-ASC-DFU

Other Intervention Name(s)

Allogeneic mesenchymal stem cells

Intervention Description

Dressing for Second Deep degree Burn injury

Intervention Type

Device

Intervention Name(s)

Conventional Therapy

Intervention Description

Typical therapy conducted for burn injury patients

Primary Outcome Measure Information:

Title

Time of re-epithelialization

Description

Time of re-epithelialization

Time Frame

Follow up to 12 weeks

Secondary Outcome Measure Information:

Title

Safety (laboratory tests and adverse events)

Description

Clinically measured abnormality of laboratory tests and adverse events

Time Frame

Follow up to 12 weeks

Title

Burn Scar Index

Description

Vancouver Burn Scar Scale

Time Frame

Follow up to 12 weeks

Title

healing status of the wound evidenced by photography

Description

healing status of the wound evidenced by photography

Time Frame

follow up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is 18 years of age and older. Subjects who have deep second-degree burn wound ≥100cm^2. 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. Subjects who are considered not suitable for the study by the investigator. Subjects who are not able to understand the objective of this study or to comply with the study requirements

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wook Chun, MD, PhD

Organizational Affiliation

Hallym University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hallym university Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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