Back to resultsA Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Deep Second-degree Burn Wound
Primary Purpose
Burn
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ALLO-ASC-DFU
Sponsored by
About this trial
This is an interventional treatment trial for Burn focused on measuring Deep Second-Degree Burn Wound
Eligibility Criteria
Inclusion Criteria:
- Subject is 18 years of age and older.
- Subjects who have deep second-degree burn ≥100 cm^2.
- Negative for urine beta-HCG for women of childbearing age.
- Subject is able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion Criteria:
- Subjects 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.
- 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 study by the investigator
- Burn wound is present on any part of the face.
- Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma site).
- 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 Type
Experimental
Arm Label
ALLO-ASC-DFU
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Secondary Outcome Measures
Time to reach re-epithelialization of wound
Evaluation of the improvement of wound measured by time to reach re-epithelialization of wound
Vancouver Burn Scar Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02394873
Brief Title
A Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Deep Second-degree Burn Wound
Official Title
A Phase 1 Clinical Study to Evaluate the Safety of Allogeneic Adipose-derived Stem Cells in the Subjects With Deep Second-degree Burn Wound
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anterogen Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn
Keywords
Deep Second-Degree Burn Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALLO-ASC-DFU
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
ALLO-ASC-DFU
Intervention Description
Dressing for second-degree burn wound.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Time to reach re-epithelialization of wound
Description
Evaluation of the improvement of wound measured by time to reach re-epithelialization of wound
Time Frame
1, 2, 4 weeks
Title
Vancouver Burn Scar Scale
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is 18 years of age and older.
Subjects who have deep second-degree burn ≥100 cm^2.
Negative for urine beta-HCG for women of childbearing age.
Subject is able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion Criteria:
Subjects 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.
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 study by the investigator
Burn wound is present on any part of the face.
Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma site).
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 Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Deep Second-degree Burn Wound
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