Status:
UNKNOWN
Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Muscular Dystrophy.
Lead Sponsor:
Chaitanya Hospital, Pune
Conditions:
Muscular Dystrophy
Duchenne Muscular Dystrophy,
Eligibility:
All Genders
6-25 years
Phase:
PHASE1
PHASE2
Brief Summary
This Study is single arm, single centre trial to check the safety and efficacy of Bone Marrow derived autologous cell(100 million per dose) for the patient with Duchenne Muscular Dystrophy.
Detailed Description
Muscular dystrophy is a group of inherited disorders that involve muscle weakness and loss of muscle tissue, which get worse over time. Duchenne muscular dystrophy is caused by a defective gene for dy...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01834066
Start Date
September 1 2014
End Date
December 1 2016
Last Update
September 17 2014
Active Locations (1)
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1
Chaitnany Hospital
Pune, Maharashtra, India, 411009