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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2026

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.

Interventions

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Anterogen Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • 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
  • Overall Contact(s)
    • Jae Hee Cheon, Ph D, GENIUSHEE@yuhs.ac

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.