Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial

ID
Name
ALLO-ASC-DFU-304
Description
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-302) for 24 months
Trial arms
Trial start
2023-04-25
Estimated PCD
2025-12-31
Trial end
2026-03-31
Status
Recruiting
Treatment
ALLO-ASC-DFU
Application of ALLO-ASC-DFU sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.
Arms:
ALLO-ASC-DFU
Vehicle sheet
Application of Vehicle sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.
Arms:
Vehicle sheet
Size
104
Primary endpoint
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
Evaluation of localized tolerance through incidence of clinically significant change about treatment area
Up to 24 months
Evaluation of incidence of adverse events
Up to 24 months
Eligibility criteria
Inclusion Criteria: 1. Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-302. 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '24 Months', 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 104, 'type': 'ESTIMATED'}}
Updated at
2023-11-21

1 organization

1 product

1 indication

Organization
Anterogen
Product
ALLO-ASC-DFU
Indication
Diabetic Foot Ulcer