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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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21 July 2016 |
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Main ID: |
NCT01759797 |
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Date of registration:
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31/12/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS
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Scientific title:
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Safety of Intravenous Transplantation of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS |
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Date of first enrolment:
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January 2013 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01759797 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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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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Nasser Aghdami, MD,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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Head of Royan department of degenerative medicine,Head of Royan celltherapy center |
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Name:
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Seyed Masoud Nabavi, 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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Proffessor assistant of Shahed University |
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Name:
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Hamid Gourabi, 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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Head of Royan Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- - Age:18-65
- both gender
- duration of disease<2 years
- FVC>40% ALS-FRS>26
Exclusion Criteria:
- - neurological and psychiatric concomitant disease
- concomitant systemic disease
- treatment with corticosteroid,Ig,immunosuppressive during 12 months.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Biological: intra venous injection of stem cell
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Primary Outcome(s)
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Unconsciousness
[Time Frame: 48hours]
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Fever
[Time Frame: 48hours]
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vomiting
[Time Frame: 48hours]
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Secondary Outcome(s)
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EMG-NCV
[Time Frame: 6months]
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FVC
[Time Frame: 6months]
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ALS-FRS
[Time Frame: 6months]
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Secondary ID(s)
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Royan-Nerve-005
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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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