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A Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Deep Second-degree Burn Wound

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ClinicalTrials.gov Identifier: NCT02394873
Recruitment Status : Completed
First Posted : March 20, 2015
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
Anterogen Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Burn Biological: ALLO-ASC-DFU Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALLO-ASC-DFU Biological: ALLO-ASC-DFU
Dressing for second-degree burn wound.




Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up to 4 weeks ]

Secondary Outcome Measures :
  1. Time to reach re-epithelialization of wound [ Time Frame: 1, 2, 4 weeks ]
    Evaluation of the improvement of wound measured by time to reach re-epithelialization of wound

  2. Vancouver Burn Scar Scale [ Time Frame: 4 weeks ]


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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 ≥100 cm^2.
  3. Negative for urine beta-HCG for women of childbearing age.
  4. Subject is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

  1. Subjects 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.
  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 study by the investigator
  10. Burn wound is present on any part of the face.
  11. Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma site).
  12. Subjects who are considered not suitable for the study by the investigator.
  13. 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): NCT02394873


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: NCT02394873     History of Changes
Other Study ID Numbers: ALLO-ASC-BI-101
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015

Keywords provided by Anterogen Co., Ltd.:
Deep Second-Degree Burn Wound

Additional relevant MeSH terms:
Burns
Wounds and Injuries