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

Sponsor
Anterogen Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03183661
Collaborator
(none)
9
Enrollment
53.4
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: ALLO-ASC-CD

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
9 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in the Subjects With Crohn´s Disease(ALLO-ASC-CD-101)
Actual Study Start Date :
Nov 16, 2016
Anticipated Primary Completion Date :
Mar 31, 2021
Anticipated Study Completion Date :
Apr 30, 2021

Arms and Interventions

Arm Intervention/Treatment
ALLO-ASC-CD injection

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

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.
Other Names:
  • Allogenic adipose-derived mesenchymal stem cell

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [up to 36 months]

      Evaluation of AE

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Anterogen Co., Ltd.

    Investigators

    • Principal Investigator: Won Ho Kim, Ph D, Yonsei University
    • Principal Investigator: Joo Sung Kim, Ph D, Seoul National University Hospital
    • Principal Investigator: Young Ho Kim, Ph D, Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anterogen Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03183661
    Other Study ID Numbers:
    • ALLO-ASC-CD-102
    First Posted:
    Jun 12, 2017
    Last Update Posted:
    Jun 12, 2017
    Last Verified:
    Jun 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Crohn Disease

    Study Results

    No Results Posted as of Jun 12, 2017