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Completed

NCT Number: NCT02394873

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

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.

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Key information

Conditions

Burn Burns Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hallym university Medical Center

Seoul, South Korea

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 ≥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.

Exclusion criteria

  • 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.

Treatment and study plan

ALLO-ASC-DFU

Biological

Dressing for second-degree burn wound.

Primary outcomes

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

    Time frame: up to 4 weeks

Secondary outcomes

  1. Time to reach re-epithelialization of wound

    Time frame: 1, 2, 4 weeks

    Evaluation of the improvement of wound measured by time to reach re-epithelialization of wound

  2. Vancouver Burn Scar Scale

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Anterogen Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 20, 2015
Registry last updated
Dec 30, 2015

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.

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