Cell Therapy in Limb Girdle Muscular Dystrophy
Overview
The purpose of this study was to study the effect of stem cell therapy on Limb Girdle Muscular Dystrophy patients.
Full Title of Study: “Intrathecal Autologous Mononuclear Cell Therapy for Limb Girdle Muscular Dystrophy”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: January 2015
Interventions
- Biological: Stem Cell
Arms, Groups and Cohorts
- Experimental: Stem Cell
Clinical Trial Outcome Measures
Primary 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 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.
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 15 Years
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Neurogen Brain and Spine Institute
- Provider of Information About this Clinical Study
- Sponsor
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.