Cell Therapy in Limb Girdle Muscular Dystrophy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02245711|
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : September 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Limb Girdle Muscular Dystrophy||Biological: Stem Cell||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intrathecal Autologous Mononuclear Cell Therapy for Limb Girdle Muscular Dystrophy|
|Study Start Date :||December 2010|
|Primary Completion Date :||January 2015|
|Study Completion Date :||June 2015|
|Experimental: Stem Cell||Biological: Stem Cell|
- Change in Functional Independence Measure (FIM) scale [ Time Frame: 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.
- Change in Manual Muscle Testing (MMT) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245711
|Neurogen brain and spine institute|
|Navi Mumbai, Maharashtra, India, 400706|