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Completed

NCT Number: NCT01845350

Safety of Autologous M2 Macrophage 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

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhagic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Novosibirsk, 630099, Russia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

M2 macrophage introduction

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Improvement of functional outcome in National Institutes of Health Stroke Scale (NIHSS)

    Time frame: 1-3 days, 6 months

  2. Improvement in Barthel Index

    Time frame: 1-3 days, 6 months

  3. Improvement in modified Rankin scale

    Time frame: 1-3 days, 6 months

Other outcomes

  1. Number of patients with recurrent vascular episodes

    Time frame: 1-3 days, 6 months

Sponsors and collaborators

Lead sponsor

Siberian Branch of the Russian Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
May 3, 2013
Registry last updated
Nov 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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