A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial

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.

• ALLO-ASC-CD (Biological), also known as Allogenic adipose-derived mesenchymal stem cell: 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.

Primary outcomes

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability [up to 36 months]: Evaluation of AE

Sex: All, ages: 18 Years to 65 Years

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.

• Jae Hee Cheon, Ph D, Principal investigator, Yonsei University
• Joo Sung Kim, Ph D, Principal investigator, Seoul National University Hospital
• Young Ho Kim, Ph D, Principal investigator, Samsung Medical Center