An observational study in Crohn Disease, sponsored by Anterogen Co., Ltd.. Recruiting at 2 sites in South Korea. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-08-25.
Sponsored by Anterogen Co., Ltd. · Observational
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.
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.
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, such as crohn's disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease.
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's planned enrollment of 9 is below the median of 166 across 624 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Anterogen Co., Ltd. is the lead sponsor of 31 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subject is enrolled who are injected ALLO-ASC-CD intravenous infusion in phase 1 clinical trial of ALLO-ASC-CD-101.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. Subjects who are considered not suitable for the study by the principal investigator.
Subjects with ALLO-ASC-CD injection in phase 1 clinical trial of ALLOASC-CD-101
Biological: ALLO-ASC-CD
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.
Also known as: Allogenic adipose-derived mesenchymal stem cell
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Evaluation of AE
Time frame: up to 36 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2016 (actual). Primary completion is estimated for Dec 2026, 121 months after the start.
Of 73 industry-sponsored observational studies under Crohn Disease, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 60. This study's planned 121 months is above that.
Counting every sponsor, half of 296 studies reached it within 42 months; a quarter within 29 and three quarters within 81.
How these figures are worked out, and which studies are left out of them.
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