Ischemic stroke
Conditions
Interventions
Sponsors
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-80 years old; 2. patients with ischemic stroke 2 to 24 months before screening, and the stroke was caused by unilateral anterior and/or middle cerebral artery; 3. patients with hemiplegia (National Institutes of Health Stroke Scale, NIHSS) scores were higher than 6 and at least one limb movement disorder); 4. neurological de?cits were stable (variety of NIHSS was smaller than 2); 5. modified Rankin Scale scores of 2–4; 6. minimum infarct diameter of 1 cm on MRI; 7. informed consent signed by patient or family member; 8. can complete follow-up.
Exclusion criteria
Exclusion criteria: 1. with 2 or more stroke attacks (TIA was not included); 2. infarct diameter was more than 8 cm; 3. with acute coronary events 3 month before or after stroke; 4. mini-mental state examination (MMSE) score was smaller than 24; 5. with a history of seizure or taking antiepileptics; 6. taking cell therapy or a history of cell therapy (blood transfusion was not included); 7. gastrointestinal tract or other severe hemorrhagic diseases within one month before screening; 8. major surgical history one week before admission; 9. patients with abnormal coagulation, severe liver and kidney diseases, mental disorders. malignant tumor or history of malignant tumor, primary or secondary immunodeficiency; 10. pregnant or lactating women; 11. involved in other clinical trials within 3 months; 12. other patients can not cooperate with clinical researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of adverse events;NIHSS scores 1, 3, 6 months after hNSC injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| modi?ed Rankin Scale scores 1, 3, 6 months after hNSC injection;Barthel index 1, 3, 6 months after hNSC injection;MMSE score 1, 3, 6 months after hNSC injection;Brain MRI 6, 12 months after hNSC injection; | — |
Countries
China
Contacts
Public ContactGuan Yangtai
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed