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The purpose of this study is to determine whether M2 macrophages are safe and feasible in the treatment of non-acute stroke patients
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M2 macrophages | Other | M2 macrophage introduction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M2 macrophage introduction | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients with severe adverse events | Occurence of severe adverse events including mortality, neurological worsening and seizures | 1-3 days, 6 months |
| Measure | Description | 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with recurrent vascular episodes | 1-3 days, 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena R. Chernykh, MD, PhD | Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch) | Novosibirsk | 630099 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26671426 | Result | 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. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Improvement in modified Rankin scale |
| 1-3 days, 6 months |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |