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NCT02065778 Clinical Trial

Safety and Efficacy of Autologous Stem Cell Therapy in Chronic Stroke

Cerebrovascular Accident Clinical Trial

Official title:
A Clinical Study of Autologous Bone Marrow Mononuclear Cells Intrathecal Transplantation in Chronic Stroke

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02065778
Other study ID # NGBSI-08
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date December 2008
Est. completion date January 2014

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 safety and effect of stem cell therapy on the functional recovery in patients with chronic stroke.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2014
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- males and females

- above 18 years of age

- diagnosed as stroke by clinical and MRI 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 in chronic stroke 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)

Borlongan CV. Bone marrow stem cell mobilization in stroke: a 'bonehead' may be good after all! Leukemia. 2011 Nov;25(11):1674-86. doi: 10.1038/leu.2011.167. Epub 2011 Jul 5. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Functional Independence Measure 6 months
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