Safety and Efficacy of Autologous Stem Cell Therapy in Chronic Stroke

NCT ID: NCT02065778

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WITHDRAWN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

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebrovascular Accident

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 in chronic stroke patients

Interventions

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Autologous bone marrow mononuclear cell transplantation

bone marrow derived mononuclear cells are administered intrathecally in chronic stroke patients

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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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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.

Reference Type BACKGROUND
PMID: 21727900 (View on PubMed)

Sharma A, Sane H, Gokulchandran N, Khopkar D, Paranjape A, Sundaram J, Gandhi S, Badhe P. Autologous bone marrow mononuclear cells intrathecal transplantation in chronic stroke. Stroke Res Treat. 2014;2014:234095. doi: 10.1155/2014/234095. Epub 2014 Jul 8.

Reference Type DERIVED
PMID: 25126443 (View on PubMed)

Other Identifiers

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NGBSI-08

Identifier Type: -

Identifier Source: org_study_id

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