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Safety of Autologous M2 Macrophage in Treatment of Non-Acute Stroke Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01845350
First Posted: May 3, 2013
Last Update Posted: November 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ekaterina Y. Shevela, Siberian Branch of the Russian Academy of Medical Sciences
  Purpose
The purpose of this study is to determine whether M2 macrophages are safe and feasible in the treatment of non-acute stroke patients

Condition Intervention Phase
Ischemic Stroke Hemorrhagic Stroke Other: M2 macrophage introduction Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of Autologous M2 Macrophage Transplantation in Treatment of Non-Acute Stroke Patients

Further study details as provided by Ekaterina Y. Shevela, Siberian Branch of the Russian Academy of Medical Sciences:

Primary Outcome Measures:
  • The number of patients with severe adverse events [ Time Frame: 1-3 days, 6 months ]
    Occurence of severe adverse events including mortality, neurological worsening and seizures


Secondary Outcome Measures:
  • Improvement of functional outcome in National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 1-3 days, 6 months ]
  • Improvement in Barthel Index [ Time Frame: 1-3 days, 6 months ]
  • Improvement in modified Rankin scale [ Time Frame: 1-3 days, 6 months ]

Other Outcome Measures:
  • Number of patients with recurrent vascular episodes [ Time Frame: 1-3 days, 6 months ]

Enrollment: 13
Study Start Date: October 2012
Study Completion Date: October 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
M2 macrophages
M2 macrophage introduction
Other: M2 macrophage introduction
  • Generation of autologous M2 macrophages from peripheral blood of non-acute stroke patients
  • Intrathecal introduction of autologous M2 macrophages

Detailed Description:
Our primary hypothesis is that autologous M2 macrophage transplantation via intrathecal introduction is feasible and safe after non-acute stroke. Our secondary hypothesis is that autologous M2 macrophage transplantation is associated with improved neurological outcome after non-acute stroke
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Computed tomography confirmed ischemic or hemorrhagic stroke
  • Duration since stroke onset more than 3 and less than 12 months
  • Age between 18 and 75 years old
  • Persistent neurological deficits more than 4 points in NIHSS stroke scale
  • Signed informed consent

Exclusion Criteria:

  • The history of previous stroke
  • Seizures
  • Thrombophilias or primary hematological diseases
  • Malignancy
  • Hepatic or renal dysfunctions
  • Hemodynamic or respiratory instability
  • Autoimmune disease
  • HIV or uncontrolled bacterial, fungal, or viral infections
  • Pregnancy
  • Participation in other clinical trials
  Contacts and Locations
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): NCT01845350


Locations
Russian Federation
Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)
Novosibirsk, Russian Federation, 630099
Sponsors and Collaborators
Siberian Branch of the Russian Academy of Medical Sciences
Investigators
Study Chair: Elena R. Chernykh, MD, PhD Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)
  More Information

Publications:
Responsible Party: Ekaterina Y. Shevela, Senior Researcher, Laboratory of Cellular Therapy, Research Institute of Clinical Immunology, Siberian Branch of the Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01845350     History of Changes
Other Study ID Numbers: STR-M2-2013
First Submitted: April 24, 2013
First Posted: May 3, 2013
Last Update Posted: November 4, 2016
Last Verified: November 2016

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