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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02619851
Recruitment Status : Active, not recruiting
First Posted : December 2, 2015
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Anterogen Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Burn Injury Biological: ALLO-ASC-DFU Device: Conventional Therapy Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arms and Interventions
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Arm Intervention/treatment
Experimental: ALLO-ASC-DFU
Allogeneic mesenchymal stem cells
 Biological: ALLO-ASC-DFU
Dressing for Second Deep degree Burn injury
Other Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Time of re-epithelialization [ Time Frame: Follow up to 12 weeks ]
    Time of re-epithelialization


Secondary Outcome Measures :
  1. Safety (laboratory tests and adverse events) [ Time Frame: Follow up to 12 weeks ]
    Clinically measured abnormality of laboratory tests and adverse events

  2. Burn Scar Index [ Time Frame: Follow up to 12 weeks ]
    Vancouver Burn Scar Scale

  3. healing status of the wound evidenced by photography [ Time Frame: follow up to 12 weeks ]
    healing status of the wound evidenced by photography


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619851


Locations
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Korea, Republic of
Hallym university Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Anterogen Co., Ltd.
Investigators
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Principal Investigator: Wook Chun, MD, PhD Hallym University Medical Center
More Information
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Responsible Party: Anterogen Co., Ltd.
ClinicalTrials.gov Identifier: NCT02619851    
Other Study ID Numbers: ALLO-ASC-BI-201
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Wounds and Injuries
Burns