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Stem Cell Therapy in Muscular Dystrophy

Primary Purpose

Muscular Dystrophy

Status

Withdrawn

Phase

Phase 1

Locations

India

Study Type

Interventional

Intervention

Stem Cell

About this trial

This is an interventional treatment trial for Muscular Dystrophy focused on measuring Muscular Dystrophy, Autologous Mononuclear cell therapy, Stem Cell

Eligibility Criteria

6 Months - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age group of 6 months and above
muscular dystrophy diagnosed on the basis of clinical presentation

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

Sites / Locations

Neurogen brain and spine institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cell

Arm Description

Bone marrow mononuclear cell transplantation

Outcomes

Primary Outcome Measures

Manual Muscle Testing

Secondary Outcome Measures

Full Information

NCT ID

NCT02241928

First Posted

September 12, 2014

Last Updated

October 23, 2018

Sponsor

Neurogen Brain and Spine Institute

1. Study Identification

Unique Protocol Identification Number

NCT02241928

Brief Title

Stem Cell Therapy in Muscular Dystrophy

Official Title

Role of Autologous Mononuclear Cell Therapy in Muscular Dystrophy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Withdrawn

Study Start Date

January 2009 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Neurogen Brain and Spine Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study was to analyze the effect of autologous bone marrow mononuclear cells in muscular dystrophy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscular Dystrophy

Keywords

Muscular Dystrophy, Autologous Mononuclear cell therapy, Stem Cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stem Cell

Arm Type

Experimental

Arm Description

Bone marrow mononuclear cell transplantation

Intervention Type

Biological

Intervention Name(s)

Stem Cell

Intervention Description

Intrathecal Autologous bone marrow mononuclear cell transplantation

Primary Outcome Measure Information:

Title

Manual Muscle Testing

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age group of 6 months and above muscular dystrophy diagnosed on the basis of clinical presentation 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

Facility Information:

Facility Name

Neurogen brain and spine institute

City

Navi Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400706

Country

India

12. IPD Sharing Statement

Learn more about this trial

Stem Cell Therapy in Muscular Dystrophy

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