Status:
RECRUITING
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
Lead Sponsor:
Anterogen Co., Ltd.
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
19-75 years
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-302) 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-302) for 24 months. ALLO-ASC-DFU is a hydrogel sheet c...
Eligibility Criteria
Inclusion
- Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-302.
- Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion
- 1\. Subjects who are considered not suitable for the study by the principal investigator.
Key Trial Info
Start Date :
April 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06141811
Start Date
April 25 2023
End Date
March 31 2026
Last Update
December 13 2024
Active Locations (4)
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1
Soonchunhyang University Hospital
Bucheon-si, Gyeonggi-do, South Korea, 14584
2
Bucheon ST. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea, 14647
3
Asan Medical Center
Seoul, South Korea, 05505
4
Borame Medical Center
Seoul, South Korea, 07061