autologous bone marrow mesenchymal stem cells (bmscs) transplantation in the treatment of ischemic stroke

Conditions: Ischemic Stroke

Summary: this study is to evaluated the safety and efficacy of bmscs transplantation in the treatment of ischemic stroke, so as to provide a basis for future clinical application of bmscs transplantation in the treatment of ischemic stroke.

1. routine treatment: 1.1. if arterial plaque is found, use lipid-lowering therapy (routine dose of atorvastatin or rosuvastatin). if no plaque is found, use atorvastatin or rosuvastatin based on the maintenance of normal blood lipid; 1.2. if venous thrombosis or arterial plaques are found in the lower limbs, use dabigatran to prevent platelet aggregation; if no vascular problems are found in the lower limbs, use aspirin or clopidogrel to prevent platelet aggregation; 1.3. during the treatment, cerebrovascular stenosis (non responsible vessels) can be treated intravascularly; 1.4. the use of neurotrophic drugs is prohibited during the study; 1.5. elevated homocysteine was treated with mecobalamin and folic acid; 1.6. hypertension, diabetes and other basic diseases receive routine treatment, and the combined medication is recorded in the case report form. 2. grouping: 2.1. bmscs group: bmscs were transplanted on the basis of routine treatment: the transplanted cells were injected intravenously and transplanted in two times, with a dose of 1 × 106 / kg body weight, each volume of 80ml ± 5ml, and the time interval between two transplants was 1 week; 2.2. routine treatment group: only receiving routine treatment;

Eligibility criteria:
inclusion criteria: 1. patients aged 18-65 years old in the rehabilitation period of cerebral infarction (including subacute stage, chronic stage and sequelae stage, with onset time ≤ 3 years), regardless of gender; 2. definite cerebral infarction in the blood supply area of middle cerebral artery confirmed by imaging; 3. there are clear neurological deficits, such as motor and cognitive dysfunction (national institutes of health stroke scale 7 \< nihss \< 21 points); 4. those who agree to take effective contraceptive measures during the study period, and women of childbearing age have negative pregnancy test; 5. sign the informed consent of the patient and agree to participate in all visits, examinations and treatments as required by the study protocol. exclusion criteria: 1. lacunar cerebral infarction; 2. acute cerebral infarction, onset time \< 2 weeks; 3. mild ischemic stroke or mild neurological impairment or severe ischemic stroke, with coma; 4. patients with moyamoya disease, vascular malformation, hemangioma and carotid stenosis exceeding 70%; 5. patients with severe heart valve disease or confirmed intractable atrial fibrillation; 6. complicated with intracranial hemorrhage or tumor; 7. patients with cerebral infarction caused by blood system diseases, or those with previous blood history or family history of blood diseases; 8. any one of 5 items of hepatitis b virus (hbsag, hbsab, hbeag, hbeab, hbcab), hepatitis c virus (hcv) antibody, human immunodeficiency virus (hiv) antibody and syphilis spiral physical examination; 9. those with severe respiratory or circulatory system or liver and kidney dysfunction who cannot tolerate treatment and examination; 10. severe febrile disease or viral disease in the past 12 weeks; 11. malignant tumor; 12. those who have a previous history of autoimmune diseases or a family history of autoimmune diseases; 13. previous history of drug allergy; 14. pregnant or lactating women; 15. those who are participating or have participated in this study or participated in other clinical trials within 12 weeks before enrollment; 16. other circumstances that the investigator considers inappropriate for participation in this study.