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

NCT02394873 | Completed Phase 1 DMC

• 1 other identifier: ALLO-ASC-BI-101
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn

Keywords

Deep Second-Degree Burn Wound

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  up to 4 weeks

Secondary Outcomes (2)

• Time to reach re-epithelialization of wound

  1, 2, 4 weeks

• Vancouver Burn Scar Scale

  4 weeks

Study Arms (1)

ALLO-ASC-DFU

EXPERIMENTAL

Biological: ALLO-ASC-DFU

Interventions

ALLO-ASC-DFU BIOLOGICAL

Dressing for second-degree burn wound.

ALLO-ASC-DFU

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

You may not qualify if:

• Subjects 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.
• 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 study by the investigator
• Burn wound is present on any part of the face.
• Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma site).
• 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 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 20, 2015
• Study Start: March 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 30, 2015

Record last verified: 2015-12

Locations

KR (1)