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Stem Cell Therapy in Limb Girdle Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT02050776
Recruitment Status : Withdrawn
First Posted : January 31, 2014
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute

Brief Summary:
The purpose of this study was to study the effect of stem cell therapy on the course of the disease in patients with Limb Girdle Muscular Dystrophy.

Condition or disease Intervention/treatment Phase
Limb Girdle Muscular Dystrophy Biological: Autologous bone marrow mononuclear cell transplantation Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Cell Therapy in Modifying the Course of Limb Girdle Muscular Dystrophy- A Longitudinal 5-year Study
Study Start Date : December 2008
Actual Primary Completion Date : March 2013
Actual Study Completion Date : December 2013


Arm Intervention/treatment
Experimental: Stem Cells
autologous bone marrow mononuclear cell transplantation
Biological: Autologous bone marrow mononuclear cell transplantation
bone marrow derived mononuclear cells are administered intrathecally and intramuscularly in limb girdle muscular dystrophy patients




Primary Outcome Measures :
  1. Functional Independence Measure [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Manual Muscle Testing [ Time Frame: 6 months ]


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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:

  • males and females
  • age group of 15 years and above
  • 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

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): NCT02050776


Locations
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India
Neurogen brain and spine institute
Mumbai, Maharashtra, India, 400071
Sponsors and Collaborators
Neurogen Brain and Spine Institute
Investigators
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Principal Investigator: Alok K Sharma, M.S., M.Ch Neurogen Brain and Spine Institute

Publications:
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Responsible Party: Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT02050776     History of Changes
Other Study ID Numbers: NGBSI-07
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophies, Limb-Girdle
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn