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Trial record 1 of 349 for:    "Muscular Dystrophies"
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Stem Cell Therapy in Muscular Dystrophy

This study is currently recruiting participants.
Verified September 2016 by Neurogen Brain and Spine Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02241928
First Posted: September 16, 2014
Last Update Posted: September 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute
  Purpose
The purpose of this study was to analyze the effect of autologous bone marrow mononuclear cells in muscular dystrophy.

Condition Intervention Phase
Muscular Dystrophy Biological: Stem Cell Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Autologous Mononuclear Cell Therapy in Muscular Dystrophy

Resource links provided by NLM:


Further study details as provided by Neurogen Brain and Spine Institute:

Primary Outcome Measures:
  • Manual Muscle Testing [ Time Frame: 1 year ]

Estimated Enrollment: 1000
Study Start Date: January 2009
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stem Cell
Bone marrow mononuclear cell transplantation
Biological: Stem Cell
Intrathecal Autologous bone marrow mononuclear cell transplantation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age group of 6 months and above
  • muscular dystrophy diagnosed on the basis of clinical presentation

Exclusion Criteria:

  • presence of respiratory distress
  • presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus
  • malignancies
  • acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction < 30%
  • pregnancy or breastfeeding
  Contacts and Locations
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): NCT02241928


Contacts
Contact: Alok K Sharma, M.S, M.Ch 022-25283706 alok276@gmail.com

Locations
India
Neurogen brain and spine institute Recruiting
Navi Mumbai, Maharashtra, India, 400706
Contact: Alok K Sharma, M.S, M.Ch    022-25283706    alok276@gmail.com   
Principal Investigator: Alok K Sharma, M.S, M.Ch         
Sponsors and Collaborators
Neurogen Brain and Spine Institute
  More Information

Responsible Party: Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT02241928     History of Changes
Other Study ID Numbers: NGBSI-14
First Submitted: September 12, 2014
First Posted: September 16, 2014
Last Update Posted: September 26, 2016
Last Verified: September 2016

Keywords provided by Neurogen Brain and Spine Institute:
Muscular Dystrophy
Autologous Mononuclear cell therapy
Stem Cell

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn