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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02241928
Other study ID # NGBSI-14
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date January 2009
Est. completion date May 2019

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 analyze the effect of autologous bone marrow mononuclear cells in muscular dystrophy.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 6 Months to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Stem Cell
Intrathecal Autologous bone marrow mononuclear cell transplantation

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Neurogen Brain and Spine Institute

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Manual Muscle Testing 1 year
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