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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: |
NCT01834066 |
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Date of registration:
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26/02/2013 |
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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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Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Muscular Dystrophy.
mdp |
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Scientific title:
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Safety and Efficacy of Bone Marrow Autologous Cells in Muscular Dystrophy. It is Self Funded (Patients' Own Funding) Clinical Trial |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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25 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01834066 |
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Study type:
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Interventional |
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Study design:
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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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India
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Contacts
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Name:
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Sachin P Jamadar, D.Ortho |
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Address:
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Telephone:
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+918888788880 |
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Email:
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sac2751982@gmail.com |
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Affiliation:
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Name:
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Sachin P Jamadar, D ORTHO |
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Address:
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Telephone:
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+918888788880 |
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Email:
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sac2751982@gmail.com |
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Affiliation:
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Name:
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ANANT E BAGUL, MS ORTHO |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHAITANYA HOSPITAL |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient with Diagnose of Duchenne Muscular Dystrophy.
- Aged in between 6 to 25 Years.
- Willingness to undergo Bone Marrow derived Autologous cell Therapy.
- Ability to comprehend the explained protocol and thereafter give an informed
consent as well as sign the required Informed Consent form(ICF) for the study.
- Ability and willingness to regular visit to hospital for protocol procedures and
follow up
Exclusion Criteria:
- Patient who is not Diagnose of Duchenne Muscular Dystrophy.
- Patient with History of Immunodeficiency HIV+,Hepatitis B ,HBV and TPPA+,Tumor
Markers+
- History of Life threatening allergic or immune -Mediated Reaction.
- the site of bone marrow aspiration potentially limiting Procedure.
- Alcohol and drug abuse / dependence.
- Patients with History of Hypertension and Hypersensitive.
Age minimum:
6 Years
Age maximum:
25 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Duchenne Muscular Dystrophy,
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Muscular Dystrophy
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Intervention(s)
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Biological: Stem Cell
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Primary Outcome(s)
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Significant Improvement in Muscle strength by using Kinetics Muscle testing or by using MMT( manual muscle test }score
[Time Frame: 6 Months]
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Secondary Outcome(s)
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-Improvement of daily living scale and baseline in EMG(electromyography)
[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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