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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01845350

Enrollment

Registered

2013-05-03

Start date

2012-10-31

Completion date

2015-10-31

Last updated

2016-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhagic Stroke, Ischemic Stroke

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

Interventions

OTHERM2 macrophage introduction

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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
Improvement in modified Rankin scale	1-3 days, 6 months

Other

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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026