Actively Recruiting
Long-term Safety Follow-up of ALLO-ASC-CD in Adults With Crohns Disease Previously Treated in Phase 1 Trial
Led by Anterogen Co., Ltd. · Updated on 2023-08-25
9
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the safety of ALLO-ASC-CD, an intravenous infusion containing allogenic adipose-derived mesenchymal stem cells, in subjects with Crohns disease who participated in a previous phase 1 clinical trial ALLO-ASC-CD-101. These stem cells target injured tissue and help reduce inflammation, which may be important for treating immune-related diseases like Crohns disease. This open-label follow-up study will monitor participants for 36 months to assess safety. The study involves only those subjects who received ALLO-ASC-CD injections during the earlier phase 1 trial. There is no new intervention in this follow-up phase it serves to observe the long-term safety of the stem cell treatment previously given. The infusion studied contains cells aimed at modulating the immune response and aiding tissue repair. Participants will be observed over 36 months with regular monitoring to record any adverse events as a measure of safety and tolerability. The study includes assessments to ensure compliance and informed consent. Researchers will track safety outcomes without additional treatments or procedures, allowing thorough long-term evaluation of the original therapys effects.
CONDITIONS
Brief Title
A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial
Research Team
J
Jae Hee Cheon, Ph D
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