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

Phase 1

Completed

• Conditions: Hemorrhagic Stroke; Ischemic Stroke
• Interventions: Other: M2 macrophage introduction

• Registration Number: NCT01845350
• Lead Sponsor: Siberian Branch of the Russian Academy of Medical Sciences

Brief Summary

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

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-05-03
• Primary Completion: 2014-04
• Study Completion: 2015-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
M2 macrophages	M2 macrophage introduction	M2 macrophage introduction

Primary Outcome Measures

Name	Time	Method
The number of patients with severe adverse events	1-3 days, 6 months	Occurence of severe adverse events including mortality, neurological worsening and seizures

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch); 🇷🇺 Novosibirsk, Russian Federation