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Cell Therapy in Limb Girdle Muscular Dystrophy

Intrathecal Autologous Mononuclear Cell Therapy for Limb Girdle Muscular Dystrophy

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02245711
Enrollment
0
Registered
2014-09-22
Start date
2010-12-31
Completion date
2015-06-30
Last updated
2018-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Limb Girdle Muscular Dystrophy

Keywords

Limb Girdle Muscular Dystrophy, Autologous Bone Marrow Mononuclear cell therapy, Stem Cell

Brief summary

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

Interventions

BIOLOGICALStem Cell

Sponsors

Neurogen Brain and Spine Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Functional Independence Measure (FIM) scale1 yearFunctional 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.

Secondary

MeasureTime frameDescription
Change in Manual Muscle Testing (MMT)1 yearManual 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.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026