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Trial record 1 of 340 for:    "Muscular Dystrophies"
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Stem Cell Therapy in Muscular Dystrophy

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Neurogen Brain and Spine Institute
Sponsor:
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier:
NCT02241928
First received: September 12, 2014
Last updated: September 23, 2016
Last verified: September 2016
  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

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
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: 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
Study First Received: September 12, 2014
Last Updated: September 23, 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

ClinicalTrials.gov processed this record on September 21, 2017