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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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19 February 2015 |
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Main ID: |
NCT02285673 |
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Date of registration:
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05/11/2014 |
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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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Efficacy of Umbilical Cord Mesenchymal Stem Cells in Duchenne Muscular Dystrophy
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Scientific title:
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Efficacy of Umbilical Cord Mesenchymal Stem Cells in Duchenne Muscular Dystrophy: Phase 1/2 Study |
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Date of first enrolment:
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November 2013 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02285673 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Ercument Ovali, Prof.Dr. |
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Address:
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Telephone:
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+905325729174 |
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Email:
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ercument.ovali@acibademlabcell.com.tr |
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Affiliation:
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Name:
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Ercument Ovali, Prof. Dr. |
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Address:
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Telephone:
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+905325729174 |
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Email:
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ercument.ovali@acibadem.com.tr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with diagnosis of DMD that is proven clinically and genetically Age between
7-20 Patients need partial respiratory support, during the day Patients have less than or
equal to stage I NIH, Liver, renal and cardiac function Patients without cancer Patients
without allergic disease Patients without bleeding diathesis,
Exclusion Criteria:
Patients need complete respiratory support Patients have more than to stage II NIH, Liver,
renal and cardiac function Patients have bleeding diathesis and allergic disease
Age minimum:
7 Years
Age maximum:
20 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Duchenne Muscular Dystrophy
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Intervention(s)
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Biological: Umbilical Cord Mesenchymal Stem Cell
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Primary Outcome(s)
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Duchenne muscular dystrophy gene expression
[Time Frame: up to 9 months]
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Secondary ID(s)
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DMD-UC-MSC-1
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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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