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NCT04590703 Clinical Trial

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

Diabetic Foot Ulcer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04590703
Other study ID # ALLO-ASC-DFU-303
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 24, 2020
Est. completion date June 2, 2023

Study information
Verified date August 2023
Source Anterogen Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date June 2, 2023
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Soonchunhyang University Hospital Bucheon Gyeonggi-do
Korea, Republic of Keimyung University Dongsan Medical Center Daegu Gyeongsangnam-do
Korea, Republic of Chungnam National University Hospital Daejeon Chungcheongnam-do
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi-do
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Nowon Eulji Medical Center, Eulji University Seoul
Korea, Republic of Ajou University Medical Center Suwon Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Anterogen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of systemic tolerance through incidence of abnormal laboratory test results Up to 9 months
Primary Evaluation of incidence of clinically significant change in physical examination and vital signs Up to 18 months
Primary Evaluation of localized tolerance through incidence of clinically significant change about treatment area Up to 24 months
Primary Evaluation of incidence of adverse events Up to 24 months
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