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Efficacy of Umbilical Cord Mesenchymal Stem Cells in Duchenne Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT02285673
Recruitment Status : Unknown
Verified November 2014 by Ercument Ovali, Acibadem University.
Recruitment status was:  Recruiting
First Posted : November 7, 2014
Last Update Posted : November 7, 2014
Sponsor:
Information provided by (Responsible Party):
Ercument Ovali, Acibadem University

Study Description
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Brief Summary:

Duchenne muscular dystrophy (DMD) is a genetic disorder caused by an absence of dystrophin and characterized by progressive muscle degeneration. There is no cure for DMD at present but, there are several strategies under-researched for treatment of DMD such as steroid treatment, gene theraphy, exon skipping, stop codon read through and gene repair, cell theraphy and theraphy with drug that help to produce utrophin protein.

The aim of this study is investigate the eficacy of human umblical cord mesenchymal stem cells on DMD and understanding if wild type gene can be transfered to the patient.


Condition or disease Intervention/treatment Phase
Duchenne Muscular Dystrophy Biological: Umbilical Cord Mesenchymal Stem Cell Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Umbilical Cord Mesenchymal Stem Cells in Duchenne Muscular Dystrophy: Phase 1/2 Study
Study Start Date : November 2013
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : November 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Umbilical Cord Mesenchymal Stem Cell Biological: Umbilical Cord Mesenchymal Stem Cell
Other Name: umbilical cord mesenchymal stem cells


Outcome Measures
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Primary Outcome Measures :
  1. Duchenne muscular dystrophy gene expression [ Time Frame: up to 9 months ]

Eligibility Criteria
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Ages Eligible for Study:   7 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285673


Contacts
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Contact: Ercument Ovali, Prof.Dr. +905325729174 ercument.ovali@acibademlabcell.com.tr
Contact: Cengiz Yakicier, Prof.Dr. 05362998743 cengiz.yakicier@asg.com.tr

Locations
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Turkey
Acibadem Labcell Recruiting
Istanbul, Uskudar, Turkey, 34662
Contact: Ercument Ovali, Prof. Dr.    +905325729174    ercument.ovali@acibadem.com.tr   
Sponsors and Collaborators
Acibadem University
More Information
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Publications:

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Responsible Party: Ercument Ovali, Specialist, Haematology, Acibadem University
ClinicalTrials.gov Identifier: NCT02285673     History of Changes
Other Study ID Numbers: DMD-UC-MSC-1
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: November 7, 2014
Last Verified: November 2014
Keywords provided by Ercument Ovali, Acibadem University:
umbilical cord, mesenchymal stem cell
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
 Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked