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Cell Therapy in Limb Girdle Muscular Dystrophy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02245711
First Posted: September 22, 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. Read our disclaimer for details.
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute
  Purpose
The purpose of this study was to study the effect of stem cell therapy on Limb Girdle Muscular Dystrophy patients.

Condition Intervention Phase
Limb Girdle 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: Intrathecal Autologous Mononuclear Cell Therapy for Limb Girdle Muscular Dystrophy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in Functional Independence Measure (FIM) scale [ Time Frame: 1 year ]
    Functional Independence Measure scale assesses the patients ability to carry out activities of daily living. At the follow up of 1 year, every patient in this study will be reevaluated on this scale.


Secondary Outcome Measures:
  • Change in Manual Muscle Testing (MMT) [ Time Frame: 1 year ]
    Manual muscle testing is a procedure for the evaluation of the function and strength of individual muscles and muscle groups based on the effective performance of a movement in relation to the forces of gravity and manual resistance. On the follow up after 1 year, every patient will be reassessed on MMT to record changes in their muscle strength after stem cell therapy.


Enrollment: 65
Study Start Date: December 2010
Study Completion Date: June 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stem Cell Biological: Stem Cell

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age group of 15 years-60 years
  • limb girdle muscular dystrophy diagnosed on the basis of clinical presentation
  • Electromyographic and Nerve Conduction velocity findings

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): NCT02245711


Locations
India
Neurogen brain and spine institute
Navi Mumbai, Maharashtra, India, 400706
Sponsors and Collaborators
Neurogen Brain and Spine Institute
  More Information

Responsible Party: Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT02245711     History of Changes
Other Study ID Numbers: NGBSI-12
First Submitted: September 12, 2014
First Posted: September 22, 2014
Last Update Posted: September 26, 2016
Last Verified: September 2016

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

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


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