Stem Cell Therapy in Muscular Dystrophy

• Sponsor: Neurogen Brain and Spine Institute (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02241928
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Duration (Months): 123.9
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study was to analyze the effect of autologous bone marrow mononuclear cells in muscular dystrophy.

Condition or Disease	Intervention/Treatment	Phase
Muscular Dystrophy	Biological: Stem Cell	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Role of Autologous Mononuclear Cell Therapy in Muscular Dystrophy
• Study Start Date: Jan 1, 2009
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stem Cell Bone marrow mononuclear cell transplantation	Biological: Stem Cell; Intrathecal Autologous bone marrow mononuclear cell transplantation

Outcome Measures

Primary Outcome Measures

1. Manual Muscle Testing [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age group of 6 months and above

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neurogen brain and spine institute	Navi Mumbai	Maharashtra	India	400706

Sponsors and Collaborators

• Neurogen Brain and Spine Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Neurogen Brain and Spine Institute
• ClinicalTrials.gov Identifier: NCT02241928
• Other Study ID Numbers: NGBSI-14
• First Posted: Sep 16, 2014
• Last Update Posted: Oct 25, 2018
• Last Verified: Oct 1, 2018

• Keywords provided by Neurogen Brain and Spine Institute: Muscular Dystrophy; Autologous Mononuclear cell therapy; Stem Cell
• Additional relevant MeSH terms: Muscular Dystrophies

Study Results

No Results Posted as of Oct 25, 2018