Ischemic stroke
Conditions
Interventions
Stage ? recovery stage and sequelae stage:Stereotactic brain stem cell transplantation
Stage ? recovery stage and sequelae stage:Transnasal endoscopic transplantation of stem cells
Stage II recovery and sequelae:Stereotactic brain stem cell transplantation
Stage II recovery and sequelae:Transnasal endoscopic transplantation of stem cells
Stage II recovery and sequelae: Control Group
Sponsors
West China Hospital, Sichuan University
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 24 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. The patient's hemiplegic side has residual upper limb motor ability (muscle strength is greater than or equal to grade 2); 6. Must have sufficient cognitive and linguistic ability to understand oral instructions and conduct research and evaluation; 7. 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. long-term anticoagulation treatment or 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 |
|---|---|
| Phase I: Incidence of adverse events and severe adverse events during and after treatment;Phase II: Improvement of NIH stroke scale (NIHSS) and Mrs Scores at 12 months after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: Neurological function scores less than 12 months after treatment: Barthel Index (Bi);Phase II: Changes in neural function scores less than 12 months after treatment: The modified Rankin scale;Phase II: Changes in neurological function scores less than 12 months after treatment: Euroqol Health Index;Phase II: Changes of neurological function scores less than 12 months after treatment: mini-mental state examination (MMSE, MOCA);Phase II: Changes of neurological function score less than 12 months after treatment: Grip Strength Test; | — |
Countries
China
Contacts
Public ContactMa Lu
West China Hospital, Sichuan University
Outcome results
None listed