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

Anterogen

Status: Enrolling

Conditions: Crohn Disease

Treatments: Biological: ALLO-ASC-CD

Study type: Observational

Funder types: Industry

Identifiers

NCT03183661

ALLO-ASC-CD-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

9 participants in 1 patient group

ALLO-ASC-CD injection

Description:

Subjects with ALLO-ASC-CD injection in phase 1 clinical trial of ALLOASC-CD-101

Treatment:

Biological: ALLO-ASC-CD