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

Burn Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619851
• Other study ID #: ALLO-ASC-BI-201
• Status: Completed
• Phase: Phase 2
• Start date: December 23, 2015
• Est. completion date: July 13, 2021

Study information

• Verified date: August 2023
• Source: Anterogen Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 13, 2021
• Est. primary completion date: July 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• 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 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

Related Conditions & MeSH terms

• Burn Injury
• Burns
• Wounds and Injuries

Intervention

Biological:
• ALLO-ASC-DFU
Dressing for Second Deep degree Burn injury

Device:
• Conventional Therapy
Typical therapy conducted for burn injury patients

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	Time of re-epithelialization	Time of re-epithelialization	Follow up to 12 weeks
Secondary	Safety (laboratory tests and adverse events)	Clinically measured abnormality of laboratory tests and adverse events	Follow up to 12 weeks
Secondary	Burn Scar Index	Vancouver Burn Scar Scale	Follow up to 12 weeks
Secondary	healing status of the wound evidenced by photography	healing status of the wound evidenced by photography	follow up to 12 weeks