Cell Therapy in Limb Girdle Muscular Dystrophy

Phase 1

Withdrawn

• Conditions: Limb Girdle Muscular Dystrophy
• Interventions: Biological: Stem Cell

• Registration Number: NCT02245711
• Lead Sponsor: Neurogen Brain and Spine Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-22
• Primary Completion: 2015-01
• Study Completion: 2015-06
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem Cell	Stem Cell	-

Primary Outcome Measures

Name	Time	Method
Change in Functional Independence Measure (FIM) scale	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

Name	Time	Method
Change in Manual Muscle Testing (MMT)	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.

Trial Locations

Locations (1)

Neurogen brain and spine institute; 🇮🇳 Navi Mumbai, Maharashtra, India