Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj

NCT ID: NCT03106259

Last Updated: 2018-02-09

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

UNKNOWN

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-29

Study Completion Date

2021-03-21

Brief Summary

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Observational Study to evaluate the safety of FURESTEM-RA lnj. in moderate to severe rheumatoid arthritis patients who participated in phase 1 clinical trial of FURESTEM-RA lnj.

Detailed Description

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This is a observational study, single center, open label, study of safety of FURESTEM-RA Inj. in subjects with moderate to severe rheumatoid arthritis.

Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.

\[NCT02221258\]

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-Interventional Study

Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.\[NCT02221258\]

FURESTEM-RA Inj.

Intervention Type DRUG

Non-interventional observational study

Interventions

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FURESTEM-RA Inj.

Non-interventional observational study

Intervention Type DRUG

Other Intervention Names

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Not applicable-observational study

Eligibility Criteria

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Inclusion Criteria

* Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.\[NCT02221258\]
* Subject who understands and voluntarily sign an informed consent form

Exclusion Criteria

* In case follow-up is not possible from end of clinical trial Phase 1 to end of this study period
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kang Stem Biotech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ki-chul Shin

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Locations

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Seoul national University Boramae medical center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KSTBT_FURESTEM_RA_EXT

Identifier Type: -

Identifier Source: org_study_id

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