- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02050776
Stem Cell Therapy in Limb Girdle Muscular Dystrophy
October 23, 2018 updated by: Neurogen Brain and Spine Institute
The Role of Cell Therapy in Modifying the Course of Limb Girdle Muscular Dystrophy- A Longitudinal 5-year Study
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maharashtra
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Mumbai, Maharashtra, India, 400071
- Neurogen brain and spine institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 60 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Stem Cells
autologous bone marrow mononuclear cell transplantation
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bone marrow derived mononuclear cells are administered intrathecally and intramuscularly in limb girdle muscular dystrophy patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Functional Independence Measure
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Manual Muscle Testing
Time Frame: 6 months
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (ACTUAL)
March 1, 2013
Study Completion (ACTUAL)
December 1, 2013
Study Registration Dates
First Submitted
January 29, 2014
First Submitted That Met QC Criteria
January 30, 2014
First Posted (ESTIMATE)
January 31, 2014
Study Record Updates
Last Update Posted (ACTUAL)
October 25, 2018
Last Update Submitted That Met QC Criteria
October 23, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NGBSI-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Limb Girdle Muscular Dystrophy
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University Hospital of North NorwayUniversity of Tromso; Norwegian Muscle Disease Association (FFM); Norwegian National... and other collaboratorsActive, not recruitingMuscular Dystrophies | Limb Girdle Muscular Dystrophy | Limb Girdle Muscular Dystrophy, Type 2I | Limb Girdle Muscular Dystrophy R9 FKRP-relatedNorway
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ML Bio Solutions, Inc.RecruitingLimb-Girdle Muscular Dystrophy Type 2I (LGMD2I)United States, Netherlands, United Kingdom, Denmark, Australia, Italy, Norway
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Linda Pax LowesRecruitingLimb-Girdle Muscular Dystrophy Type 2A | Limb-Girdle Muscular Dystrophy, Type 2EUnited States
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Virginia Commonwealth UniversityUniversity of Colorado, Denver; Washington University School of Medicine; University... and other collaboratorsRecruitingLimb Girdle Muscular Dystrophy | Calpain-3 Deficiency Limb Girdle Muscular Dystrophy Type 2A | Limb Girdle Muscular Dystrophy Type R1 | LGMD2AUnited States, United Kingdom
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Rigshospitalet, DenmarkCompletedBecker Muscular Dystrophy | Limb-Girdle Muscular Dystrophy Type 2IDenmark
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Nationwide Children's HospitalMyonexus TherapeuticsRecruitingLimb-Girdle Muscular Dystrophy, Type 2EUnited States
-
Cooperative International Neuromuscular Research...Carolinas Medical Center lead study siteCompletedBecker Muscular Dystrophy | Limb-Girdle Muscular Dystrophy, Type 2A (Calpain-3 Deficiency) | Limb-Girdle Muscular Dystrophy, Type 2B (Miyoshi Myopathy, Dysferlin Deficiency) | Limb-Girdle Muscular Dystrophy, Type 2I (FKRP-deficiency)United States
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IRCCS San Camillo, Venezia, ItalyUniversita di Verona; Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico and other collaboratorsEnrolling by invitationCalpain-3 Deficiency Limb Girdle Muscular Dystrophy Type 2AItaly
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University of North Carolina, Chapel HillNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsCompletedMuscular Dystrophies | Duchenne Muscular Dystrophy | Becker Muscular Dystrophy | Limb-Girdle Muscular DystrophyUnited States
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Wake Forest University Health SciencesMuscular Dystrophy AssociationCompletedMuscular Dystrophies, Limb-Girdle (GENETICALLY CONFIRMED)United States
Clinical Trials on Autologous bone marrow mononuclear cell transplantation
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Vinmec Research Institute of Stem Cell and Gene...Vinmec Health Care System (Vingroup Joint Stock Company)Completed
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Neurogen Brain and Spine InstituteWithdrawnCerebrovascular AccidentIndia
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Shandong UniversityUnknownDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type 1China
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Neurogen Brain and Spine InstituteWithdrawn
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Neurogen Brain and Spine InstituteWithdrawn
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Neurogen Brain and Spine InstituteWithdrawn
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Neurogen Brain and Spine InstituteWithdrawn
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Neurogen Brain and Spine InstituteWithdrawn
-
Neurogen Brain and Spine InstituteWithdrawn
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Vinmec Research Institute of Stem Cell and Gene...RecruitingSequelae of Injuries of HeadVietnam