Stem Cell Therapy in Limb Girdle Muscular Dystrophy

NCT ID: NCT02050776

Last Updated: 2018-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Limb Girdle Muscular Dystrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stem Cells

autologous bone marrow mononuclear cell transplantation

Group Type EXPERIMENTAL

Autologous bone marrow mononuclear cell transplantation

Intervention Type BIOLOGICAL

bone marrow derived mononuclear cells are administered intrathecally and intramuscularly in limb girdle muscular dystrophy patients

Interventions

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Autologous bone marrow mononuclear cell transplantation

bone marrow derived mononuclear cells are administered intrathecally and intramuscularly in limb girdle muscular dystrophy patients

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neurogen Brain and Spine Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alok K Sharma, M.S., M.Ch

Role: PRINCIPAL_INVESTIGATOR

Neurogen Brain and Spine Institute

Locations

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Neurogen brain and spine institute

Mumbai, Maharashtra, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 24070109 (View on PubMed)

Other Identifiers

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NGBSI-07

Identifier Type: -

Identifier Source: org_study_id

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