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

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Procedure: Vehicle sheet; Biological: ALLO-ASC-DFU

• Registration Number: NCT04590703
• Lead Sponsor: Anterogen Co., Ltd.

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2020-06-24
• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Primary Completion: 2021-09-30
• Study Completion: 2023-06-02
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vehicle sheet	Vehicle sheet	Subjects with Vehicle sheet treatment in phase 3 clinical trial of ALLO-ASC-DFU-301
ALLO-ASC-DFU	ALLO-ASC-DFU	Subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial of ALLO-ASC-DFU-301

Primary Outcome Measures

Name	Time	Method
Evaluation of incidence of adverse events	Up to 24 months
Evaluation of localized tolerance through incidence of clinically significant change about treatment area	Up to 24 months
Evaluation of systemic tolerance through incidence of abnormal laboratory test results	Up to 9 months
Evaluation of incidence of clinically significant change in physical examination and vital signs	Up to 18 months

Trial Locations

Locations (8)

Ajou University Medical Center; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Gyeongsangnam-do, Korea, Republic of

Soonchunhyang University Hospital; 🇰🇷 Bucheon, Gyeonggi-do, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Chungcheongnam-do, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Nowon Eulji Medical Center, Eulji University; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of