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NCT03183661 Clinical Trial

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

Crohn Disease Clinical Trial

Official title:
Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in the Subjects With Crohn´s Disease(ALLO-ASC-CD-101)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03183661
Other study ID # ALLO-ASC-CD-102
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 16, 2016
Est. completion date December 31, 2026

Study information
Verified date August 2023
Source Anterogen Co., Ltd.
Contact Jae Hee Cheon, Ph D
Email GENIUSHEE@yuhs.ac
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 9
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• ALLO-ASC-CD
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.

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Anterogen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events as a Measure of Safety and Tolerability Evaluation of AE up to 36 months
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