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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02394873
Other study ID # ALLO-ASC-BI-101
Secondary ID
Status Completed
Phase Phase 1
First received March 6, 2015
Last updated December 28, 2015
Start date March 2015
Est. completion date October 2015

Study information

Verified date December 2015
Source Anterogen Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date October 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
ALLO-ASC-DFU
Dressing for second-degree burn wound.

Locations

Country Name City State
Korea, Republic of Hallym university Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Anterogen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events as a Measure of Safety and Tolerability up to 4 weeks Yes
Secondary Time to reach re-epithelialization of wound Evaluation of the improvement of wound measured by time to reach re-epithelialization of wound 1, 2, 4 weeks No
Secondary Vancouver Burn Scar Scale 4 weeks No
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