A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
1 other identifier
observational
104
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2023
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2023
CompletedFirst Submitted
Initial submission to the registry
November 2, 2023
CompletedFirst Posted
Study publicly available on registry
November 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedDecember 13, 2024
December 1, 2024
2.7 years
November 2, 2023
December 10, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
ALLO-ASC-DFU
Subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial of ALLO-ASC-DFU-302
Vehicle sheet
Subjects with Vehicle sheet treatment in phase 3 clinical trial of ALLO-ASC-DFU-302
Interventions
Application of ALLO-ASC-DFU sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.
Application of Vehicle sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.
Eligibility Criteria
ubjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-302.
You may qualify if:
- 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.
You may not qualify if:
- \. Subjects who are considered not suitable for the study by the principal investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Soonchunhyang University Hospital
Bucheon-si, Gyeonggi-do, 14584, South Korea
Bucheon ST. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Borame Medical Center
Seoul, 07061, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ChangSik Park, MD. Ph D
Asan Medical Center
- PRINCIPAL INVESTIGATOR
JiUng Bak, MD. Ph D
Borame Medical Center
- PRINCIPAL INVESTIGATOR
DaeWon Jun, MD. Ph D
Bucheon St. Mary's Hospital
- PRINCIPAL INVESTIGATOR
YoungKoo Lee, MD. Ph D
Soonchunhyang University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2023
First Posted
November 21, 2023
Study Start
April 25, 2023
Primary Completion
December 31, 2025
Study Completion
March 31, 2026
Last Updated
December 13, 2024
Record last verified: 2024-12