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

Siberian Branch of the Russian Academy of Medical Sciences

Status and phase: Completed; Phase 1

Conditions: Ischemic Stroke; Hemorrhagic Stroke

Treatments: Other: M2 macrophage introduction

Study type: Interventional

Funder types: Other

Identifiers

NCT01845350

STR-M2-2013

Details and patient eligibility

About

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

Full 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

Enrollment: 13 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

M2 macrophages

Other group

Description:

M2 macrophage introduction

Treatment:

Other: M2 macrophage introduction