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NCT02050776 Clinical Trial

Stem Cell Therapy in Limb Girdle Muscular Dystrophy

Limb Girdle Muscular Dystrophy Clinical Trial

Official title:
The Role of Cell Therapy in Modifying the Course of Limb Girdle Muscular Dystrophy- A Longitudinal 5-year Study

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02050776
Other study ID # NGBSI-07
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date December 2008
Est. completion date December 2013

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

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender All
Age group 15 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Autologous bone marrow mononuclear cell transplantation
bone marrow derived mononuclear cells are administered intrathecally and intramuscularly in limb girdle muscular dystrophy patients

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

Sponsors (1)
Lead Sponsor Collaborator
Neurogen Brain and Spine Institute

Country where clinical trial is conducted

India, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Functional Independence Measure 6 months
Secondary Manual Muscle Testing 6 months
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