Follow-up on the safety of ALLO-ASC-CD for Crohn's disease
Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in the Subjects With Crohn´s Disease(ALLO-ASC-CD-101)
This study is checking the safety of a stem cell treatment for Crohn's disease in people who have already tried it in a previous trial, by monitoring them for three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 9 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Anterogen Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT03183661 on ClinicalTrials.gov |
What this trial studies
This observational follow-up study evaluates the safety of ALLO-ASC-CD, an intravenous infusion of allogenic adipose-derived mesenchymal stem cells, in patients previously treated in the ALLO-ASC-CD-101 clinical trial. The study will monitor participants for 36 months to assess any safety concerns related to the treatment. The approach focuses on the potential of these stem cells to reduce inflammation and modulate the immune response in individuals with Crohn's disease. By tracking the long-term effects, the study aims to provide valuable insights into the safety profile of this innovative treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals who participated in the ALLO-ASC-CD-101 clinical trial and received the ALLO-ASC-CD injection.
Not a fit: Patients who did not receive ALLO-ASC-CD in the previous trial or those deemed unsuitable by the principal investigator may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new safe treatment option for patients with Crohn's disease.
How similar studies have performed: While this study builds on previous findings from the ALLO-ASC-CD-101 trial, the specific follow-up safety evaluation is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects who are injected with ALLO-ASC-CD in phase 1 clinical trial of ALLO-ASC-CD-101. 2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: 1\. Subjects who are considered not suitable for the study by the principal investigator.
Where this trial is running
Seoul and 1 other locations
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Severance Hospital — Seoul, South Korea (Completed)
Study contacts
- Principal investigator: Jae Hee Cheon, Ph D — Yonsei University
- Study coordinator: Jae Hee Cheon, Ph D
- Email: GENIUSHEE@yuhs.ac
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.