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

NCT02619851 | Completed Phase 2

• 1 other identifier: ALLO-ASC-BI-201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Injury

Outcome Measures

Primary Outcomes (1)

• Time of re-epithelialization

  Time of re-epithelialization

  Follow up to 12 weeks

Secondary Outcomes (3)

• Safety (laboratory tests and adverse events)

  Follow up to 12 weeks

• Burn Scar Index

  Follow up to 12 weeks

• healing status of the wound evidenced by photography

  follow up to 12 weeks

Study Arms (2)

ALLO-ASC-DFU

EXPERIMENTAL

Allogeneic mesenchymal stem cells

Biological: ALLO-ASC-DFU

Conventional Therapy

ACTIVE COMPARATOR

Typical therapy conducted for burn injury patients

Device: Conventional Therapy

Interventions

ALLO-ASC-DFU BIOLOGICAL

Dressing for Second Deep degree Burn injury

Also known as: Allogeneic mesenchymal stem cells

ALLO-ASC-DFU

Conventional Therapy DEVICE

Typical therapy conducted for burn injury patients

Conventional Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18 years of age and older.
• Subjects who have deep second-degree burn wound ≥100cm\^2.
• TBSA(Total burn surface area) ≤ 30%
• Negative for Urine beta-HCG for women of childbearing age.
• Subject is able to give written informed consent prior to study start and comply with the study requirements.

You may not qualify if:

• Subject who have been enrolled in another clinical study within 30 days of screening.
• Subjects who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.
• Subjects who are receiving steroids, immunosuppressive, or anticoagulant for long term
• Subjects with active infection.
• Subjects with hemorrhagic and hemocoagulative disease.
• Subjects who are unwilling to use an "effective" method of contraception during the study.
• Subjects who have a history of malignant tumor within the last five years, or is currently undergoing.
• Subjects who are pregnant or breast-feeding.
• Subjects who are considered to have a significant disease which can impact the wound healing by the investigator
• Burn wound is present on any part of the face.
• Subjects who are considered not suitable for the study by the investigator.
• Subjects who are not able to understand the objective of this study or to comply with the study requirements

Sponsors & Collaborators

• Anterogen Co., Ltd.: lead

Study Sites (1)

Hallym university Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Wook Chun, MD, PhD

  Hallym University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 2, 2015
• Study Start: December 23, 2015
• Primary Completion: July 2, 2019
• Study Completion: July 13, 2021
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

KR (1)