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Autologous Stem Cell Therapy in Stroke

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ClinicalTrials.gov Identifier: NCT02245698
Recruitment Status : Withdrawn
First Posted : September 19, 2014
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute

Brief Summary:
The purpose of this study was to study the safety and effect of stem cell therapy on the functional recovery in patients with sub acute/chronic stroke.

Condition or disease Intervention/treatment Phase
Stroke Biological: Stem cell Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Mononuclear Cells Intrathecal Transplantation in Stroke
Study Start Date : December 2008
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Stem Cell
Bone marrow mononuclear cells
Biological: Stem cell
Intrathecal autologous bone marrow mononuclear cell transplantation




Primary Outcome Measures :
  1. Functional Independence Measure [ Time Frame: 1 year ]
    Functional Independence Measure scale assesses the patients ability to carry out activities of daily living. At the follow up of 1 year, every patient in this study will be reevaluated on this scale.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age18 years-80 years
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245698


Locations
India
Neurogen brain and spine institute
Navi Mumbai, Maharashtra, India, 400706
Sponsors and Collaborators
Neurogen Brain and Spine Institute

Responsible Party: Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT02245698     History of Changes
Other Study ID Numbers: NGBSI-11
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Neurogen Brain and Spine Institute:
Chronic Stroke
Subacute stroke
Autologous Bone Marrow Mononuclear Cell therapy
Stem cell

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases