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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02926300 |
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Date of registration:
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11/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Long-term Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)
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Scientific title:
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Extension Study, An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trials to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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24 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02926300 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Eun-ji Kang |
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Address:
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Telephone:
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Email:
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ejkang@kangstem.com |
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Affiliation:
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Name:
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Suk-kyun Yang |
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Address:
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Telephone:
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Email:
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Affiliation:
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Asan Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients who has history of FURESTEM-CD Inj. injection at least once.
- patients who understand and voluntarily sign an informed consent form.
Exclusion Criteria:
- any other condition which the Principle Investigator judges would make subject
unsuitable for study participation.
Age minimum:
19 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Biological: stem cells
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Primary Outcome(s)
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all kinds of adverse events which occur during the clinical sutdy
[Time Frame: 114 weeks]
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Secondary Outcome(s)
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ratio of patients who is applicable to CDAI<150
[Time Frame: 114 weeks]
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ratio of patients who reduce CDAI over 70 as contrasted witd baseline(V7)
[Time Frame: 114 weeks]
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Secondary ID(s)
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KSTHD_FURESTEM-CD-EXT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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