Ischemic Stroke
Conditions
Interventions
Group 1 of convalescent with ischemic stroke:single dose i.v.-hMSCs5.0×10^7
Group 2 of convalescent with ischemic stroke:single dose i.v.-hMSCs10.0×10^7
Group 3 of convalescent with ischemic stroke :single dose i.v.-hMSCs20.0×10^7
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age range from 18 to 80, gender unlimited (including 18 and 80 years old); 2. Patients who were diagnosed as convalescent with ischemic stroke on imaging (convalescent period was defined as 12 to 24 weeks after the first symptom of stroke (including W12 and W24)) and met the diagnosis of anterior circulation infarction; 3. NIHSS score of 6-20 (including 6 and 20), and NIHSS score item 1a < 2; 4. Life expectancy =12 months; 5. Understand and follow study procedures and voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Current or previous epilepsy, dementia, Parkinson's disease, major depression, or other neurological disorders or mental illnesses that the investigator believes will affect their ability to participate in the study or affect the study evaluation; 2. Current or past intracranial hemorrhagic diseases (such as: cerebral hemorrhage, epidural hematoma, subdural hematoma, subarachnoid hemorrhage, ventricle hemorrhage, traumatic cerebral hemorrhage, etc.) or cerebral tumors, history of brain trauma, encephalitis and other symptoms leading to apoplexy; 3. Current or past severe cardiovascular disease: Congestive heart failure (NYHA grade 3 or 4); Myocardial infarction within 6 months prior to screening; Severe arrhythmia; Poorly controlled hypertension (systolic blood pressure =180mmHg or diastolic blood pressure=110mmHg despite optimal treatment) 4. Patients with pulmonary embolism, interstitial pneumonia, radiation pneumonia, drug-related pneumonia, severe impairment of lung function and other severe lung infections or other lung diseases (except those caused by stroke, bed rest after stroke or stroke treatment); 5. Have any other clinically serious medical conditions currently or in the past that the investigators judge unsuitable for inclusion in this study, including but not limited to severe liver (e.g., cirrhosis, etc.), kidney (e.g., kidney diseases requiring hemodialysis or peritoneal dialysis, etc.), blood (e.g., hemophilia with bleeding tendencies, etc.), endocrine (e.g.,Diabetes mellitus with difficult blood glucose control (blood glucose > 16.8mmol/L or 2.5 x normal limit (ULN) and/or cereal third transaminase (ALT) > 2.5 x ULN, serum total bilirubin (TBIL) > 1.5 x ULN. creatinine clearance (CrCL) 1.7 or part of the blood coagulation kinase time (APTT) > 1.25 x ULN. 8. Hepatitis B virus surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive for HBV-DNA, positive for hepatitis C virus antibody (HCVAb), treponema pallidum antibody (TPAb/RPR) or human immunodeficiency virus antibody (HIV), or within 14 days prior to receiving the test drug treatment,The emergence of any infected persons in need of systematic anti-infective treatment; 9. Allergic constitution or history, or allergic to the test drug or any component of the test drug; 10. Patients with MRI contraindications; 11. Positive blood pregnancy test results for female subjects of reproductive age within 7 days prior to receiving the experimental drug treatment;All women of reproductive age, fertile men or their spouses who refused to use appropriate contraception (including at least one barrier contraceptive) throughout the study period, and lactating women; 12. Those who required systemic corticosteroids (> 10mg/ day prednisone therapeutic dose) or other immunosup
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE/SAE; | — |
Countries
China
Contacts
Public ContactHao Junwei
Xuanwu Hospital Capital Medical University
Outcome results
None listed