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

Siberian Branch of the Russian Academy of Medical Sciences13 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemic Stroke Hemorrhagic Stroke

Interventions

M2 macrophage introductionOTHER

* Generation of autologous M2 macrophages from peripheral blood of non-acute stroke patients * Intrathecal introduction of autologous M2 macrophages

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)

Novosibirsk, Russia

Outcomes

Primary Outcomes

The number of patients with severe adverse events

Occurence of severe adverse events including mortality, neurological worsening and seizures

Time frame: 1-3 days, 6 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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