Ischemic stroke
Conditions
Interventions
Low-dose:intranasal transplantation of 1×10^6/200 ul/×2 cells,two transplants at 14-day intervals
Middle-dose:intranasal transplantation of 5×10^6/200 ul/×2 cells,two transplants at 14-day intervals
High-dose:intranasal transplantation of 2.5×10^7/500 ul/×2 cells,two transplants at 14-day intervals
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The brain CT or/and MRI were confirmed as cerebral infarction in the middle cerebral artery blood supply area, and the time according to the stage: Recovery period: 3 months to 6 months; Sequelae period: 7 months to 60 months; 2. Age 30-75, male or female; 3. NIHSS score >= 4, mRS score 3-4; 4. The score of Essen Stroke Risk Rating Scale (ESRS) is less than 4; 5. Must have sufficient cognitive and linguistic ability to understand oral instructions and conduct research and evaluation; 6. Obtain the informed consent of the subject or legal representative, volunteer for the test, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. In addition to cerebral infarction, complicated with other neurological diseases; 2. A history of grand mal or refractory epilepsy within the last 6 months; 3. Blood system diseases, bone marrow examination found myelodysplastic or other malignant diseases; 4. have immune system defects or are receiving radiation or chemotherapy; 5. People with a history of severe drug allergy or allergic constitution; 6. Patients suffering from malignant tumor, major organ failure, severe infection or other serious complications; 7. Subjects who are pregnant, preparing for pregnancy or breastfeeding; 8. Participating in other clinical studies or participating in other clinical studies within 3 months; 9. Have participated in other clinical research or treatment of neural stem cell transplantation. 10.Patients or legal representatives refuse to participate in the study, or patients cannot cooperate to complete the study due to mental, cognitive, language and other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events and severe adverse events ;Improvement of NIH stroke scale (NIHSS) and mRS Scores at 12 months after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Barthel Index, BI;The modified Rankin scale;Euroqol Health Index;Mini-mental state examination;Grip Strength Test; | — |
Countries
China
Contacts
Public ContactBao Xinjie
Peking Union Medical College Hospital
Outcome results
None listed