Ischemic stroke
Conditions
Interventions
Stage I recovery stage and sequelae stage:Brain stereotactic transplant stem cells
Stage I recovery stage and:Nasal endoscopic transplantation of stem cells
Stage II recovery and sequelae:Brain stereotactic transplant stem cells
Stage II recovery and sequelae:Nasal endoscopic transplantation of stem cells
Stage II recovery and sequelae:Control group
Sponsors
The Sixth Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. New middle cerebral artery infarction confirmed by head CT or/and MRI in men and women aged 30-75 years; 2. The symptoms did not improve within 72 to 144 hours of onset; 3. NIHSS score is 4-24 points, among which the 5th and 6th (examination of dyspraxia) scores are not less than 2 points at the time of selection; 4. Existing imaging examinations showed that the supply vessels of the infarct area were less than 50% stenosis; 5. Before the onset of the disease, mRS Score <=1 point; 6. Negative pregnancy test for women of childbearing age; 7. Subject or legal representative signs informed consent, and subject can cooperate to complete follow-up.
Exclusion criteria
Exclusion criteria: 1. Consciousness disorder, NIHSS score 1a (to judge the degree of consciousness) >=2 points and clinical indication of early cerebral hernia syndrome; 2. Complicated with tumor disease (not yet cured) and deficient immune system; 3. Head CT or MRI suggested cerebral hemorrhage, subarachnoid hemorrhage, moyamoya disease, and suspected amyloid cerebrovascular disease. 4. Active period of infectious diseases, such as HIV, hepatitis B, hepatitis C, etc. 5. Previous epilepsy, dementia, or developmental delays that are poorly controlled by medication; 6. Existing internal diseases: pulmonary diseases (moderate to severe asthma, COPD, etc.); Unstable angina or myocardial ischemia; After mechanical heart valve replacement, atrial myxoma; Coagulation dysfunction (INR>1.4, PTT>37 seconds), thrombocytopenia (PLT150U/L, and/or serum total bilirubin >1.6mg/dl; 8. Poor blood pressure control (>180/100mmHg), body temperature >38 degree centigrade; 9. Participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage I: incidence of adverse events and serious adverse events during and after treatment;;Phase II: Improvement of the National Institutes of Health Stroke Scale (NIHSS) and mRS scores at 12 months after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Barthel Index (BI);Modified Rankin scale;EuroQol Health Index Scale;Simplified Intelligence Scale (MMSE, MoCA);Grip force detection; | — |
Countries
China
Contacts
Public ContactQi Xiaokun
The Sixth Medical Center of PLA General Hospital
Outcome results
None listed