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

Burn Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394873
• Other study ID #: ALLO-ASC-BI-101
• 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

• Burn
• Burns

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