Stem Cell Therapy in Duchenne Muscular Dystrophy

Phase 1

Withdrawn

• Conditions: Duchenne Muscular Dystrophy
• Interventions: Biological: Stem Cell

• Registration Number: NCT02241434
• Lead Sponsor: Neurogen Brain and Spine Institute

Brief Summary

The purpose of this study was to study the effect of stem cell therapy in patients with Duchenne Muscular Dystrophy.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-12
• Study First Posted: 2014-09-16
• Primary Completion: 2016-01
• Study Completion: 2016-06
• 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• Status: WITHDRAWN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 3-25 years
• Duchenne muscular dystrophy diagnosed on the basis of clinical presentation

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	bone marrow mononuclear cell transplantation

Primary Outcome Measures

Name	Time	Method
Manual Muscle Testing	1 year

Secondary Outcome Measures

Name	Time	Method
Brooke and Vignos Scale	1 year

Trial Locations

Locations (1)

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