Overview
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.
Description
- 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
Inclusion Criteria:
- 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;
- Definite cerebral infarction in the blood supply area of middle cerebral artery confirmed by imaging;
- There are clear neurological deficits, such as motor and cognitive dysfunction (National Institutes of Health Stroke Scale 7 < NIHSS < 21 points);
- Those who agree to take effective contraceptive measures during the study period, and women of childbearing age have negative pregnancy test;
- 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:
- Lacunar cerebral infarction;
- Acute cerebral infarction, onset time < 2 weeks;
- Mild ischemic stroke or mild neurological impairment or severe ischemic stroke, with coma;
- Patients with moyamoya disease, vascular malformation, hemangioma and carotid stenosis exceeding 70%;
- Patients with severe heart valve disease or confirmed intractable atrial fibrillation;
- Complicated with intracranial hemorrhage or tumor;
- Patients with cerebral infarction caused by blood system diseases, or those with previous blood history or family history of blood diseases;
- 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;
- Those with severe respiratory or circulatory system or liver and kidney dysfunction who cannot tolerate treatment and examination;
- Severe febrile disease or viral disease in the past 12 weeks;
- Malignant tumor;
- Those who have a previous history of autoimmune diseases or a family history of autoimmune diseases;
- Previous history of drug allergy;
- Pregnant or lactating women;
- Those who are participating or have participated in this study or participated in other clinical trials within 12 weeks before enrollment;
- Other circumstances that the investigator considers inappropriate for participation in this study.
