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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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15 August 2016 |
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Main ID: |
NCT02855112 |
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Date of registration:
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22/07/2016 |
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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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Allogeneic Adipose Derived Stem Cells for Werdnig Hoffman Patients
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Scientific title:
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The Effectiveness of Allogeneic Adipose Derived Mesenchymal Stem Cells (ADMSCs) in the Phenotypic Changes of Werdnig Hoffman Patients |
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Date of first enrolment:
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June 2015 |
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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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https://clinicaltrials.gov/show/NCT02855112 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-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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Iran, Islamic Republic of
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Contacts
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Name:
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Amir Ali Hamidieh, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hematology-Oncology & Stem cell Transplant Research center, Tehran University of Medical Sciences |
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Name:
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Mahmoode Reza Ashrafi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Medical Hospital, Tehran University of Medical Sciences |
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Name:
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Rashin Mohseni, PhD |
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Address:
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Telephone:
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+989123430627 |
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Email:
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rashin_mohseni@yahoo.com |
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Affiliation:
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Name:
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Rashin Mohseni, PhD |
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Address:
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Telephone:
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+989123230627 |
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Email:
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rashin_mohseni@yahoo.com |
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Affiliation:
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Name:
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Rashin Mohseni, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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School of Advanced Technologies in Medicine, Tehran University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Age under 12 month, Weak muscle tone, Weakness in mobility, Patients sitting without full
conduction of nerve Existence of home senses, Normal Brain function
Exclusion Criteria:
Age beyound 12 month, Brain abnormality, Loss of sensory functions Malignancies
Age minimum:
5 Months
Age maximum:
12 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Infantile Spinal Muscular Atrophy, Type I [Werdnig- Hoffman]
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Intervention(s)
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Biological: Adipose derived mesenchymal stem cell
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Primary Outcome(s)
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Changes in action potential of muscles on ElectroMyoGram (EMG) test
[Time Frame: Change from Baseline of intervention at 3 month]
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Secondary Outcome(s)
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Changes in Motility on Modified Barthel Index Score
[Time Frame: Change from Baseline of intervention at 1 year]
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Secondary ID(s)
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94-01-87-28524
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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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