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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Chaitanya Hospital, Pune
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier:
NCT01834066
First received: February 26, 2013
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Bone Marrow Autologous Cells in Muscular Dystrophy.

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • -Improvement of daily living scale and baseline in EMG(electromyography) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 )

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.

  Eligibility

Ages Eligible for Study:   6 Years to 25 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01834066

Contacts
Contact: Sachin P Jamadar, D.Ortho +918888788880 sac2751982@gmail.com
Contact: Smita S Bhoyar, B.A.M.S.PGCR 9372620569 drsmitabhoyar@rediff.com

Locations
India
Chaitnany Hospital Recruiting
Pune, Maharashtra, India, 411009
Contact: Sachin P Jamadar, D ORTHO    +918888788880    sac2751982@gmail.com   
Contact: Smita S Bhoyar, BAMS.PGCR    9372620569    drsmitabhoyar@rediffmail.com   
Principal Investigator: ANANT E BAGUL, MS ORTHO         
Sponsors and Collaborators
Chaitanya Hospital, Pune
Investigators
Principal Investigator: ANANT E BAGUL, MS ORTHO CHAITANYA HOSPITAL
  More Information

No publications provided

Responsible Party: Dr. Sachin Jamadar, C0- Investigator, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier: NCT01834066     History of Changes
Other Study ID Numbers: 00101
Study First Received: February 26, 2013
Last Updated: April 15, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Chaitanya Hospital, Pune:
muscular Dystrophy stem cell

Additional relevant MeSH terms:
Muscular Dystrophy, Duchenne
Muscular Dystrophies
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 24, 2014