Ischemic Stroke Clinical Trial
Official title:
Safety and Feasibility of Autologous M2 Macrophage Transplantation 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
Status | Completed |
Enrollment | 13 |
Est. completion date | October 2015 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Russian Federation | Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch) | Novosibirsk |
Lead Sponsor | Collaborator |
---|---|
Siberian Branch of the Russian Academy of Medical Sciences |
Russian Federation,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of patients with recurrent vascular episodes | 1-3 days, 6 months | Yes | |
Primary | The number of patients with severe adverse events | Occurence of severe adverse events including mortality, neurological worsening and seizures | 1-3 days, 6 months | Yes |
Secondary | Improvement of functional outcome in National Institutes of Health Stroke Scale (NIHSS) | 1-3 days, 6 months | No | |
Secondary | Improvement in Barthel Index | 1-3 days, 6 months | No | |
Secondary | Improvement in modified Rankin scale | 1-3 days, 6 months | No |
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