A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial
- Conditions
- Crohn Disease
- Interventions
- Biological: ALLO-ASC-CD
- Registration Number
- NCT03183661
- Lead Sponsor
- Anterogen Co., Ltd.
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 9
- 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.
- Subjects who are considered not suitable for the study by the principal investigator.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ALLO-ASC-CD injection ALLO-ASC-CD Subjects with ALLO-ASC-CD injection in phase 1 clinical trial of ALLOASC-CD-101
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and Tolerability up to 36 months Evaluation of AE
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of