Stem Cell Therapy in Limb Girdle Muscular Dystrophy

• Sponsor: Neurogen Brain and Spine Institute (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02050776
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Duration (Months): 60
• 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 the course of the disease in patients with Limb Girdle Muscular Dystrophy.

Condition or Disease	Intervention/Treatment	Phase
Limb Girdle Muscular Dystrophy	Biological: Autologous bone marrow mononuclear cell transplantation	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: The Role of Cell Therapy in Modifying the Course of Limb Girdle Muscular Dystrophy- A Longitudinal 5-year Study
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stem Cells autologous bone marrow mononuclear cell transplantation	Biological: Autologous bone marrow mononuclear cell transplantation; bone marrow derived mononuclear cells are administered intrathecally and intramuscularly in limb girdle muscular dystrophy patients

Outcome Measures

Primary Outcome Measures

1. Functional Independence Measure [6 months]

Secondary Outcome Measures

1. Manual Muscle Testing [6 months]

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neurogen brain and spine institute	Mumbai	Maharashtra	India	400071

Sponsors and Collaborators

• Neurogen Brain and Spine Institute

Investigators

• Principal Investigator: Alok K Sharma, M.S., M.Ch, Neurogen Brain and Spine Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

• Sharma A, Sane H, Badhe P, Gokulchandran N, Kulkarni P, Lohiya M, Biju H, Jacob VC. A clinical study shows safety and efficacy of autologous bone marrow mononuclear cell therapy to improve quality of life in muscular dystrophy patients. Cell Transplant. 2013;22 Suppl 1:S127-38. doi: 10.3727/096368913X672136. Epub 2013 Sep 10.

• Responsible Party: Neurogen Brain and Spine Institute
• ClinicalTrials.gov Identifier: NCT02050776
• Other Study ID Numbers: NGBSI-07
• First Posted: Jan 31, 2014
• Last Update Posted: Oct 25, 2018
• Last Verified: Oct 1, 2018

• Additional relevant MeSH terms: Muscular Dystrophies; Muscular Dystrophies, Limb-Girdle

Study Results

No Results Posted as of Oct 25, 2018