Cell Therapy in Limb Girdle Muscular Dystrophy

Limb Girdle Muscular Dystrophy Clinical Trial

Official title:

Intrathecal Autologous Mononuclear Cell Therapy for Limb Girdle Muscular Dystrophy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02245711
• Other study ID #: NGBSI-12
• Status: Withdrawn
• Phase: Phase 1
• Start date: December 2010
• Est. completion date: June 2015

Study information

• Verified date: October 2018
• Source: Neurogen Brain and Spine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Limb Girdle Muscular Dystrophy
• Muscular Dystrophies

Intervention

Biological:
• Stem Cell

Locations

Country	Name	City	State
India	Neurogen brain and spine institute	Navi Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Neurogen Brain and Spine Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Functional Independence Measure (FIM) scale	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.	1 year
Secondary	Change in Manual Muscle Testing (MMT)	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.	1 year