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

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ClinicalTrials.gov Identifier: NCT02619851
Recruitment Status : Unknown
Verified April 2016 by Anterogen Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : December 2, 2015
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
Anterogen Co., Ltd.

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 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 : July 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

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




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

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



Information from the National Library of Medicine

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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 ≥100cm2.
  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

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


Contacts
Contact: Wook Chun, MD, PhD 82-2-2639-5114 chun0414@hallym.ac.kr

Locations
Korea, Republic of
Hallym university Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Anterogen Co., Ltd.
Investigators
Principal Investigator: Wook Chun, MD, PhD Hallym University Medical Center

Responsible Party: Anterogen Co., Ltd.
ClinicalTrials.gov Identifier: NCT02619851     History of Changes
Other Study ID Numbers: ALLO-ASC-BI-201
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Wounds and Injuries
Burns