| Eligibility |
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. Life expectancy =12 months;
4. Understand and follow study procedures and voluntarily sign written informed consent.
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;
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 < 2.8mmol/L), or complicated with severe
neurovascular complications, etc.), immune system (active or uncontrolled autoimmune
diseases, primary or secondary immune deficiencies, etc.), malignant tumors (except
cured non-melanoma skin cancer, cervical or breast ductal carcinoma in situ), etc.;
6. 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;
7. Allergic constitution or history, or allergic to the test drug or any component of the
test drug;
8. Patients with MRI contraindications;
9. 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;
10. Those who required systemic corticosteroids (> 10mg/ day prednisone therapeutic dose)
or other immunosuppressive agents within 14 days prior to receiving the trial drug or
during the study period;
11. Patients who used butylphthalein within 3 weeks before receiving the experimental
drug;
12. participated in any clinical trial and took any investigational drug within 3 months
prior to receiving the investigational drug treatment (or the last time receiving the
investigational drug did not exceed 5 half-lives, whichever is longer);
13. Patients who had severe trauma or major surgery within 3 months before receiving the
experimental drug treatment, or who plan to undergo surgery during the trial
period;Patients with a history of blood transfusion within 3 months before receiving
the experimental drug treatment;
14. Those who had a history of drug abuse or alcoholism within 1 year before receiving the
experimental drug treatment;
15. Those who have previously received other stem cell treatments;
16. Participants with other severe, acute, or chronic medical conditions that may increase
the patient's risk or may interfere with the interpretation of the test results are
judged by the investigator to be unsuitable for clinical trials.
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