A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-201 Clinical Trial
1 other identifier
observational
54
1 country
4
Brief Summary
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-DFU-201) for 23 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2015
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 29, 2015
CompletedFirst Submitted
Initial submission to the registry
June 8, 2017
CompletedFirst Posted
Study publicly available on registry
June 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2018
CompletedAugust 25, 2023
August 1, 2023
2.6 years
June 8, 2017
August 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Evaluation of AE
up to 24 months
Study Arms (2)
ALLO-ASC-DFU
Subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial of ALLO-ASC-DFU-201
Standard therapy
Subjects with Standard therapy in phase 2 clinical trial of ALLO-ASC-DFU-201
Interventions
Application of ALLO-ASC-DFU sheet to diabetic foot ulcer. This study is a follow-up study without intervention.
Standard therapy conducted for patients with diabetic foot ulcer. This study is a follow-up study without intervention.
Eligibility Criteria
Subject is enrolled who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-DFU-201.
You may qualify if:
- Subjects who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-DFU-201.
- 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)
Eulji General Hospital
Seoul, 01830, South Korea
Severance Hospital
Seoul, 03722, South Korea
Asan medical center
Seoul, 05505, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Kyu Han, MD. Ph D.
Korea University Guro Hospital
- PRINCIPAL INVESTIGATOR
Ki-Won Young, MD. Ph D.
Eulji General Hospital
- PRINCIPAL INVESTIGATOR
Hyun-suk Suh, MD. Ph D.
Asan Medical Center
- PRINCIPAL INVESTIGATOR
Jin Woo Lee, MD. Ph D.
Severance Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2017
First Posted
June 12, 2017
Study Start
December 29, 2015
Primary Completion
August 17, 2018
Study Completion
October 24, 2018
Last Updated
August 25, 2023
Record last verified: 2023-08