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

NCT ID: NCT03183661

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-16

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Crohn Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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ALLO-ASC-CD injection

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

ALLO-ASC-CD

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Allogenic adipose-derived mesenchymal stem cell

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anterogen Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jae Hee Cheon, Ph D

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Joo Sung Kim, Ph D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Young Ho Kim, Ph D

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Severance Hospital

Seoul, , South Korea

Site Status COMPLETED

Countries

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South Korea

Central Contacts

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Jae Hee Cheon, Ph D

Role: CONTACT

Facility Contacts

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Joosung Kim, MD, Ph.D.

Role: primary

Other Identifiers

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ALLO-ASC-CD-102

Identifier Type: -

Identifier Source: org_study_id

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