Stem Cell Therapy in Limb Girdle Muscular Dystrophy
The Role of Cell Therapy in Modifying the Course of Limb Girdle Muscular Dystrophy- A Longitudinal 5-year Study
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2008
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 29, 2014
CompletedFirst Posted
Study publicly available on registry
January 31, 2014
CompletedOctober 25, 2018
October 1, 2018
4.2 years
January 29, 2014
October 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Functional Independence Measure
6 months
Secondary Outcomes (1)
Manual Muscle Testing
6 months
Study Arms (1)
Stem Cells
EXPERIMENTALautologous bone marrow mononuclear cell transplantation
Interventions
bone marrow derived mononuclear cells are administered intrathecally and intramuscularly in limb girdle muscular dystrophy patients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neurogen brain and spine institute
Mumbai, Maharashtra, 400071, India
Related Publications (1)
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.
PMID: 24070109BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alok K Sharma, M.S., M.Ch
Neurogen Brain and Spine Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2014
First Posted
January 31, 2014
Study Start
December 1, 2008
Primary Completion
March 1, 2013
Study Completion
December 1, 2013
Last Updated
October 25, 2018
Record last verified: 2018-10