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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03106259
Date of registration: 03/04/2017
Prospective Registration: No
Primary sponsor: Kang Stem Biotech Co., Ltd.
Public title: Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj
Scientific title: Observational Study to Evaluate the Safety of FURESTEM-RA Inj. in Moderate to Severe Rheumatoid Arthritis Patients Who Participated in Phase 1 Clinical Trial of FURESTEM-RA Inj
Date of first enrolment: June 29, 2016
Target sample size: 9
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT03106259
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Korea, Republic of
Contacts
Name:     Ki-chul Shin
Address: 
Telephone:
Email:
Affiliation:  SMG-SNU Boramae Medical Center
Key inclusion & exclusion criteria

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



Age minimum: 19 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: FURESTEM-RA Inj.
Primary Outcome(s)
Safety of FURESTEM-RA Inj. [Time Frame: 5 years]
Secondary Outcome(s)
Secondary ID(s)
KSTBT_FURESTEM_RA_EXT
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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