Stem Cell Therapy in Limb Girdle Muscular Dystrophy

Phase 1

Withdrawn

• Conditions: Limb Girdle Muscular Dystrophy
• Interventions: Biological: Autologous bone marrow mononuclear cell transplantation

• Registration Number: NCT02050776
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2013-03
• Study Completion: 2013-12
• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-01-31
• 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• Status: WITHDRAWN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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem Cells	Autologous bone marrow mononuclear cell transplantation	autologous bone marrow mononuclear cell transplantation

Primary Outcome Measures

Name	Time	Method
Functional Independence Measure	6 months

Secondary Outcome Measures

Name	Time	Method
Manual Muscle Testing	6 months

Trial Locations

Locations (1)

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