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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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12 December 2020 |
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Main ID: |
NCT02050776 |
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Date of registration:
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29/01/2014 |
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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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Stem Cell Therapy in Limb Girdle Muscular Dystrophy
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Scientific title:
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The Role of Cell Therapy in Modifying the Course of Limb Girdle Muscular Dystrophy- A Longitudinal 5-year Study |
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Date of first enrolment:
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December 2008 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02050776 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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India
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Contacts
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Name:
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Alok K Sharma, M.S., M.Ch |
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Address:
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Telephone:
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Email:
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Affiliation:
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Neurogen Brain and Spine Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- males and females
- age group of 15 years and above
- limb girdle muscular dystrophy diagnosed on the basis of clinical presentation
- Electromyographic and Nerve Conduction velocity findings
Exclusion Criteria:
- presence of respiratory distress
- presence of acute infections such as Human Immunodeficient Virus/Hepatitis B
Virus/Hepatitis C Virus
- malignancies
- acute medical conditions such as respiratory infection, fever, hemoglobin less than 8,
bleeding tendency, bone marrow disorder, left ventricular ejection fraction < 30%
- pregnancy or breastfeeding
Age minimum:
15 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Limb Girdle Muscular Dystrophy
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Intervention(s)
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Biological: Autologous bone marrow mononuclear cell transplantation
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Primary Outcome(s)
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Functional Independence Measure
[Time Frame: 6 months]
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Secondary Outcome(s)
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Manual Muscle Testing
[Time Frame: 6 months]
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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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