Clinical trial

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

Name

ALLO-ASC-CD-102

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.

Trial arms

Trial start

2016-11-16

Estimated PCD

2026-12-31

Trial end

2026-12-31

Status

Recruiting

Treatment

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.

Arms:

ALLO-ASC-CD injection

Other names:

Allogenic adipose-derived mesenchymal stem cell

Size

Primary endpoint

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

up to 36 months

Eligibility 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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 9, 'type': 'ESTIMATED'}}

Updated at

2023-08-25

1 organization

Organization

Anterogen