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

Anterogen Co., Ltd.73 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetic Foot Ulcer

Interventions

ALLO-ASC-DFUBIOLOGICAL

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

Vehicle sheetPROCEDURE

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-301. 2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: 1\. Subjects who are considered not suitable for the study by the principal investigator.

Locations (8)

Chungnam National University Hospital

Daejeon, Chungcheongnam-do, South Korea

Soonchunhyang University Hospital

Bucheon-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Ajou University Medical Center

Suwon, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Evaluation of systemic tolerance through incidence of abnormal laboratory test results

Time frame: Up to 9 months

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

Time frame: Up to 18 months

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

Time frame: Up to 24 months

Evaluation of incidence of adverse events

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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