Ischemic stroke
Conditions
Interventions
Experimental group 2:Intrathecal injection
Experimental group 1:Intravenous injection
Experimental group 3:Intravenous + intrathecal injection
Control group:None
Sponsors
Beijing Darwin Cell Biotechnology Co., Ltd.
Eligibility
Sex/Gender
All
Age
45 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Be able to understand the study requirements, provide written informed consent, be able to understand and provide written authorization for the use and disclosure of the subject's Protected Health Information (PHI)’’, and comply with the study procedures; 2. Meet the diagnostic criteria of acute ischemic stroke in the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, onset 1-6 months, age 45-60 years, and confirmed by head CT or MRI to exclude cerebral hemorrhage; 3. Women must have a negative serum pregnancy test and use appropriate contraceptive methods or be infertile (at least 2 years after menopause or having undergone hysterectomy, oophorectomy or sterilization); 4. A history of complete ischemic stroke in subcortical regions supplied with blood from the middle cerebral artery (MCA) or lenticulostriate artery, with or without cortical ischemic injury, can be found by head magnetic resonance imaging (MRI); 5. Modified Rankin score of 2, 3 or 4; 6. Hemiplegia on one side of the limb, Fogomel motor function (FMMS) score < 85 (i.e., with moderate-severe dyskinesia); 7. NIHSS score was evaluated twice within 3 weeks before surgery, and the fluctuation of NIHSS score was between plus and minus 4; 8. Able and willing to complete all follow-up visits; 9. Be able and willing to undertake later physical therapy and rehabilitation; 10. Can cooperate with all inspections; 11. Sign the informed consent according to ethical requirements.
Exclusion criteria
Exclusion criteria: 1. Any history of neurodegenerative or psychiatric disorders that may directly affect the evaluation process of this study. Including any disease that involves cognitive impairment; 2. A history of more than one symptomatic stroke, but transient ischemic attack (TIAs) is acceptable; 3. A history of other severe neurological injuries; 4. The maximum diameter of cerebral infarction was greater than 8cm in any measurement; 5. Patients with a history of myocardial infarction within 3 months before screening; 6. Have a history of epilepsy or are currently taking antiepileptic drugs; 7. Participated in clinical studies of any other drug or medical device during the 30 days prior to screening; 8. Received other intracellular treatments in addition to blood transfusion; 9. Any of the following concomitant diseases or conditions: (1) Coagulation dysfunction, preoperative INR > 1.4; (2) The Panel Reactive Antibodies (PRA) were > 20% at initial screening; (3) Preoperative active infection; (4) Hypotension requiring vasopressor therapy; (5) Skin damage in the operation area; (6) A history of malignant tumor or previous malignant tumor; (7) Primary or secondary immune deficiency; (8) Persistent MRI artifacts, unable to obtain clear MRI images before or after surgery, or unable to perform MRI examination; (9) Serum creatinine >115µmol/L; (10) Liver function (ASpartate aminotransferase/alanine aminotransferase, total bilirubin, alkaline phosphatase) > 2 times the upper limit of normal; (11) Hematocrit (%)/hemochrome (g/L) 180mmHg or diastolic blood pressure >100mmHg); (14) Uncontrolled diabetes mellitus (HBA1C >8%); (15) Occult blood test revealed gastrointestinal bleeding; (16) Positive tuberculosis; (17) Positive test for B surface antigen or hepatitis C antibody; (18) Test positive for human immunodeficiency virus (HIV); 10. Any of the following conditions: (1) Current drug or alcohol abuse; (2) Unstable health status; (3) Unstable mental illness, including psychosis and untreated major depression; 11. Any circumstances in the opinion of the investigator or the attending physician that may affect participation in the clinical study or may cause harm to the patient; 12. Any conditions that the surgeon considers likely to cause postoperative complications; 13. Known allergy to tacrolimus or methylprednisone; 14. Had taken antiplatelet drugs within 2 weeks before the operation; 15. Severe heart insufficiency, liver and kidney dysfunction and other organ dysfunction; 16. Patients who have undergone pacemaker surgery, coronary intervention or coronary surgical bypass surgery, or have other metal products in their bodies; 17. Patients with underlying medical history that may lead to motor dysfunction; 18. Patients with incomplete medical history.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-meyer Scale of Motor Function;adverse events and incidence;neurological function;quality of life improvement; | — |
Countries
China
Contacts
Public ContactChen Lin
Outcome results
None listed