A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial
Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in the Subjects With Crohn´s Disease(ALLO-ASC-CD-101)
1 other identifier
observational
9
1 country
2
Brief Summary
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2016
Longer than P75 for all trials
2 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
November 16, 2016
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
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
August 25, 2023
August 1, 2023
10.1 years
June 8, 2017
August 23, 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 36 months
Study Arms (1)
ALLO-ASC-CD injection
Subjects with ALLO-ASC-CD injection in phase 1 clinical trial of ALLOASC-CD-101
Interventions
ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells are directed to injured tissue, and reduce inflammation. Furthermore their immunomodulatory effects are significant for treating immune-related disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease. This study is a follow-up study without intervention.
Eligibility Criteria
Subject is enrolled who are injected ALLO-ASC-CD intravenous infusion in phase 1 clinical trial of ALLO-ASC-CD-101.
You may qualify if:
- Subjects who are injected with ALLO-ASC-CD in phase 1 clinical trial of ALLO-ASC-CD-101.
- 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 (2)
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae Hee Cheon, Ph D
Yonsei University
- PRINCIPAL INVESTIGATOR
Joo Sung Kim, Ph D
Seoul National University Hospital
- PRINCIPAL INVESTIGATOR
Young Ho Kim, Ph D
Samsung Medical Center
Central Study Contacts
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
November 16, 2016
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
August 25, 2023
Record last verified: 2023-08