Cell Therapy in Limb Girdle Muscular Dystrophy

• Sponsor: Neurogen Brain and Spine Institute (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02245711
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Duration (Months): 54
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Limb Girdle 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: Intrathecal Autologous Mononuclear Cell Therapy for Limb Girdle Muscular Dystrophy
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stem Cell	Biological: Stem Cell

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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: NCT02245711
• Other Study ID Numbers: NGBSI-12
• First Posted: Sep 22, 2014
• Last Update Posted: Oct 25, 2018
• Last Verified: Oct 1, 2018

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

Study Results

No Results Posted as of Oct 25, 2018