Safety of Autologous M2 Macrophage in Treatment of Non-Acute Stroke Patients
NCT ID: NCT01845350
Last Updated: 2016-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2012-10-31
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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M2 macrophages
M2 macrophage introduction
M2 macrophage introduction
* Generation of autologous M2 macrophages from peripheral blood of non-acute stroke patients
* Intrathecal introduction of autologous M2 macrophages
Interventions
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M2 macrophage introduction
* Generation of autologous M2 macrophages from peripheral blood of non-acute stroke patients
* Intrathecal introduction of autologous M2 macrophages
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Siberian Branch of the Russian Academy of Medical Sciences
OTHER
Responsible Party
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Ekaterina Y. Shevela
Senior Researcher, Laboratory of Cellular Therapy, Research Institute of Clinical Immunology
Principal Investigators
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Elena R. Chernykh, MD, PhD
Role: STUDY_CHAIR
Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)
Locations
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Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)
Novosibirsk, , Russia
Countries
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References
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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.
Other Identifiers
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STR-M2-2013
Identifier Type: -
Identifier Source: org_study_id