Skip to main content
OpenTrials
Completed

NCT Number: NCT02619851

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Burn Injury Burns Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hallym university Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

ALLO-ASC-DFU

Biological

Dressing for Second Deep degree Burn injury

Other names: Allogeneic mesenchymal stem cells

Conventional Therapy

Device

Typical therapy conducted for burn injury patients

Primary outcomes

  1. Time of re-epithelialization

    Time frame: Follow up to 12 weeks

    Time of re-epithelialization

Secondary outcomes

  1. Safety (laboratory tests and adverse events)

    Time frame: Follow up to 12 weeks

    Clinically measured abnormality of laboratory tests and adverse events

  2. Burn Scar Index

    Time frame: Follow up to 12 weeks

    Vancouver Burn Scar Scale

  3. healing status of the wound evidenced by photography

    Time frame: follow up to 12 weeks

    healing status of the wound evidenced by photography

Sponsors and collaborators

Lead sponsor

Anterogen Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
Dec 2, 2015
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.