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

November 3, 2016 updated by: Ekaterina Y. Shevela, Siberian Branch of the Russian Academy of Medical Sciences

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

The purpose of this study is to determine whether M2 macrophages are safe and feasible in the treatment of non-acute stroke patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630099
        • Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-3 days, 6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Number of patients with recurrent vascular episodes
Time Frame: 1-3 days, 6 months
1-3 days, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 3, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STR-M2-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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