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Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Muscular Dystrophy. (mdp)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Dr. Sachin Jamadar, Chaitanya Hospital, Pune.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune Identifier:
First received: February 26, 2013
Last updated: September 16, 2014
Last verified: September 2014
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 Intervention Phase
Muscular Dystrophy Duchenne Muscular Dystrophy, Biological: Stem Cell Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Dr. Sachin Jamadar, Chaitanya Hospital, Pune:

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

Estimated Enrollment: 25
Study Start Date: September 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 )

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 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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01834066

Contact: Sachin P Jamadar, D.Ortho +918888788880

Chaitnany Hospital Recruiting
Pune, Maharashtra, India, 411009
Contact: Sachin P Jamadar, D ORTHO    +918888788880   
Principal Investigator: ANANT E BAGUL, MS ORTHO         
Sponsors and Collaborators
Chaitanya Hospital, Pune
  More Information

Responsible Party: Dr. Sachin Jamadar, C0- Investigator, Chaitanya Hospital, Pune Identifier: NCT01834066     History of Changes
Other Study ID Numbers: 00101
Study First Received: February 26, 2013
Last Updated: September 16, 2014

Keywords provided by Dr. Sachin Jamadar, Chaitanya Hospital, Pune:
muscular Dystrophy stem cell

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked processed this record on September 21, 2017