Cell Therapy in Limb Girdle Muscular Dystrophy

Phase 1WithdrawnNCT02245711

Neurogen Brain and Spine Institute

Overview

The purpose of this study was to study the effect of stem cell therapy on Limb Girdle Muscular Dystrophy patients.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Limb Girdle Muscular Dystrophy

Interventions

Stem CellBIOLOGICAL

Eligibility

Sex: ALLMin age: 15 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Neurogen brain and spine institute

Navi Mumbai, Maharashtra, India

Outcomes

Primary Outcomes

Change in Functional Independence Measure (FIM) scale

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.

Time frame: 1 year

Secondary Outcomes

Change in Manual Muscle Testing (MMT)

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.

Time frame: 1 year

Data from ClinicalTrials.gov

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