Back to resultsSafety of Autologous M2 Macrophage in Treatment of Non-Acute Stroke Patients
Primary Purpose
Ischemic Stroke, Hemorrhagic Stroke
Status
Completed
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
M2 macrophage introduction
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility Criteria
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
Sites / Locations
- Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
M2 macrophages
Arm Description
M2 macrophage introduction
Outcomes
Primary Outcome Measures
The number of patients with severe adverse events
Occurence of severe adverse events including mortality, neurological worsening and seizures
Secondary Outcome Measures
Improvement of functional outcome in National Institutes of Health Stroke Scale (NIHSS)
Improvement in Barthel Index
Improvement in modified Rankin scale
Full Information
NCT ID
NCT01845350
First Posted
April 24, 2013
Last Updated
November 3, 2016
Sponsor
Siberian Branch of the Russian Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01845350
Brief Title
Safety of Autologous M2 Macrophage in Treatment of Non-Acute Stroke Patients
Official Title
Safety and Feasibility of Autologous M2 Macrophage Transplantation in Treatment of Non-Acute Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Siberian Branch of the Russian Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Hemorrhagic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
M2 macrophages
Arm Type
Other
Arm Description
M2 macrophage introduction
Intervention Type
Other
Intervention Name(s)
M2 macrophage introduction
Intervention Description
Generation of autologous M2 macrophages from peripheral blood of non-acute stroke patients
Intrathecal introduction of autologous M2 macrophages
Primary Outcome Measure Information:
Title
The number of patients with severe adverse events
Description
Occurence of severe adverse events including mortality, neurological worsening and seizures
Time Frame
1-3 days, 6 months
Secondary Outcome Measure Information:
Title
Improvement of functional outcome in National Institutes of Health Stroke Scale (NIHSS)
Time Frame
1-3 days, 6 months
Title
Improvement in Barthel Index
Time Frame
1-3 days, 6 months
Title
Improvement in modified Rankin scale
Time Frame
1-3 days, 6 months
Other Pre-specified Outcome Measures:
Title
Number of patients with recurrent vascular episodes
Time Frame
1-3 days, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena R. Chernykh, MD, PhD
Organizational Affiliation
Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)
Official's Role
Study Chair
Facility Information:
Facility Name
Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
26671426
Citation
Chernykh ER, Shevela EY, Starostina NM, Morozov SA, Davydova MN, Menyaeva EV, Ostanin AA. Safety and Therapeutic Potential of M2 Macrophages in Stroke Treatment. Cell Transplant. 2016;25(8):1461-71. doi: 10.3727/096368915X690279. Epub 2015 Dec 14.
Results Reference
result
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Safety of Autologous M2 Macrophage in Treatment of Non-Acute Stroke Patients
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