Study Safety and Efficacy of BMMNC for the Patient With Duchenne Muscular Dystrophy (BMMNC)
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|ClinicalTrials.gov Identifier: NCT01834040|
Recruitment Status : Unknown
Verified September 2014 by Dr. Sachin Jamadar, Chaitanya Hospital, Pune.
Recruitment status was: Recruiting
First Posted : April 17, 2013
Last Update Posted : September 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Muscular Dystrophy Duchenne Muscular Dystrophy||Other: Intralesional/ Intravenous of Autologous Stem cells.||Phase 1 Phase 2|
Muscular dystrophies, or MD, are a group of inherited conditions, which means they are passed down through families. They may occur in childhood or adulthood. There are many different types of muscular dystrophy. They include:
Duchenne muscular dystrophy is a form of muscular dystrophy that worsens quickly. Other muscular dystrophy (including Becker's muscular dystrophy) get worse much more slowly.
Duchenne muscular dystrophy is caused by a defective gene for dystrophin (a protein in the muscles). However, it often occurs in people without a known family history of the condition.
Symptoms usually appear before age 6 and may appear as early as infancy. They may include:
Learning difficulties (the IQ (intelligence quotient )can be below 75)
Intellectual disability (possible, but does not get worse over time)
Begins in the legs and pelvis, but also occurs less severely in the arms, neck, and other areas of the body
Difficulty with motor skills (running, hopping, jumping)
Trouble getting up from a lying position or climbing stairs
Weakness quickly gets worse
Progressive difficulty walking
Ability to walk may be lost by age 12, and the child will have to use a wheelchair
Breathing difficulties and heart disease usually start by age 20
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study Safety and Efficacy of of AUTOLOGOUS Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) for the Patient With Duchenne Muscular Dystrophy. It is Self Funded (Patients' Own Funding) Clinical Trial|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||October 2016|
intralesional and Intravenous
Intralesional/ Intravenous of Autologous Stem cells.
Other: Intralesional/ Intravenous of Autologous Stem cells.
Intralesional/ Intravenous of Autologous MNCs per dose
- Improvement of daily living scale. [ Time Frame: 6 MONTH ]
- Improvement of Muscular dystrophy specific functional Rating scale [ Time Frame: 6 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834040
|Contact: Sachin S Jamadar, Dorthofirstname.lastname@example.org|
|Pune, Maharashtra, India, 411009|
|Contact: Sachin S Jamadar, D ORTHO +918888788880 email@example.com|
|Principal Investigator:||ANANT E BAGUL, M.S||CHAITANYA HOSPITAL|