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NCT Number: NCT04590703

A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-301 Clinical Trial

This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chungnam National University Hospital, Daejeon, Chungcheongnam-do, South Korea

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About this study

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months. 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 a Diabetic Foot Ulcer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-301.
  • Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion criteria

  • Subjects who are considered not suitable for the study by the principal investigator.

Treatment and study plan

ALLO-ASC-DFU

Biological

Application of ALLO-ASC-DFU sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.

Vehicle Sheet

Procedure

Application of Vehicle sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.

Primary outcomes

  1. Evaluation of systemic tolerance through incidence of abnormal laboratory test results

    Time frame: Up to 9 months

  2. Evaluation of incidence of clinically significant change in physical examination and vital signs

    Time frame: Up to 18 months

  3. Evaluation of localized tolerance through incidence of clinically significant change about treatment area

    Time frame: Up to 24 months

  4. Evaluation of incidence of adverse events

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

Anterogen Co., Ltd.

Industry

Registry information

Official study title

A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 3 Clinical Trial of ALLO-ASC-DFU-301

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Oct 19, 2020
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.

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