Actively Recruiting
Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in the Subjects With Crohn's Disease (ALLO-ASC-CD-101)
Led by Anterogen Co., Ltd. · Updated on 2023-08-25
9
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
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 Crohn's 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 Crohn's 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 therapy's effects.
CONDITIONS
Brief Title
A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who received ALLO-ASC-CD injection in the phase 1 ALLO-ASC-CD-101 clinical trial
- Subjects able to provide written informed consent before starting the study
- Subjects able to comply with the study requirements
You will not qualify if you...
- Subjects considered not suitable for the study by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 36 months
Participants who previously received ALLO-ASC-CD injection in an earlier trial are monitored for safety and tolerability over time.
Trial Site Locations
Total: 2 locations
1
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
2
Severance Hospital
Seoul, South Korea, 03722
Completed
Research Team
J
Jae Hee Cheon, Ph D
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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