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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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ClinicalTrials.gov Identifier: NCT01834066
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
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune

Study Description
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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.

Condition or disease Intervention/treatment Phase
Muscular Dystrophy Duchenne Muscular Dystrophy, Biological: Stem Cell Phase 1 Phase 2

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 dystrophin (a protein in the muscles). However, it often occurs in people without a known family history of the condition. slowly progress diseases.it causes Muscle weaknesses, Difficulty with motor skills ,Progressive difficulty walking.Breathing difficulties and heart disease,Frequent falls,weak limbs,lose motor Function.Begins in the legs and pelvis, but also occurs less severely in the arms, neck, and other areas of the body.Trouble getting up from a lying position or climbing stairs.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Bone Marrow Autologous Cells in Muscular Dystrophy. It is Self Funded (Patients' Own Funding) Clinical Trial
Study Start Date : September 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
STEM CELL
Intra thecal transplantation of autologous Stem Cell MNCs
 Biological: Stem Cell
Intralesional transfer of Autologous Stem cell (MNCs) per dose. 6 doses in 3 months
Other Name: Intravenous transfer of Autologous Stem Cell ( MNCs )


Outcome Measures
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Primary Outcome Measures :
  1. Significant Improvement in Muscle strength by using Kinetics Muscle testing or by using MMT( manual muscle test }score [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. -Improvement of daily living scale and baseline in EMG(electromyography) [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01834066


Contacts
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Contact: Sachin P Jamadar, D.Ortho +918888788880 sac2751982@gmail.com

Locations
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India
Chaitnany Hospital Recruiting
Pune, Maharashtra, India, 411009
Contact: Sachin P Jamadar, D ORTHO    +918888788880    sac2751982@gmail.com   
Principal Investigator: ANANT E BAGUL, MS ORTHO         
Sponsors and Collaborators
Chaitanya Hospital, Pune
Investigators
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Principal Investigator: ANANT E BAGUL, MS ORTHO CHAITANYA HOSPITAL
More Information
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Responsible Party: Dr. Sachin Jamadar, C0- Investigator, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier: NCT01834066     History of Changes
Other Study ID Numbers: 00101
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014
Keywords provided by Dr. Sachin Jamadar, Chaitanya Hospital, Pune:
muscular Dystrophy stem cell
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
 Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked