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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Siberian Branch of the Russian Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Ekaterina Y. Shevela, Siberian Branch of the Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01845350
First received: April 24, 2013
Last updated: April 29, 2013
Last verified: April 2013
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Improvement in Barthel Index [ Time Frame: 1-3 days, 6 months ] [ Designated as safety issue: No ]
  • Improvement in modified Rankin scale [ Time Frame: 1-3 days, 6 months ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 15
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845350

Contacts
Contact: Nataliya M Starostina, MD +7(383)228-27-41 starostina48@bk.ru
Contact: Ekaterina Y Shevela, MD +7(383)236-03-29 shevelak@mail.ru

Locations
Russian Federation
Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch) Recruiting
Novosibirsk, Russian Federation, 630099
Contact: Elena R Chernykh, MD, PhD    +7(383)236-03-29    ct_lab@mail.ru   
Contact: Ekaterina Y Shevela, MD    +7(383)236-03-29    shevelak@mail.ru   
Principal Investigator: Mariya N Davydova         
Sub-Investigator: Ekaterina Y Shevela, MD         
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

No publications provided

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
Study First Received: April 24, 2013
Last Updated: April 29, 2013
Health Authority: Russia: Ethics Committee

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

ClinicalTrials.gov processed this record on September 18, 2014