Hemiplegic sequelae following ischemic stroke
Conditions
Interventions
low-dose cohort:Multi-target intracerebral delivery of hNPC01 cells (1.5×10e7 total cells) via 15 precise injection points.
mid-dose cohort:Multi-target intracerebral delivery of hNPC01 cells (3.0×10e7 total cells) via 15 precise injection points.
high-dose cohort:Multi-target intracerebral delivery of hNPC01 cells (6.0×10e7 total cells) via 15 precise injection points.
Sponsors
Neurosurgery Department of Seventh Medical Center, Senior Department of Neurosurgery, the First Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. **Voluntary Participation in Clinical Research** - The participant or their legal guardian has been fully informed and provided written informed consent. - Willingness and ability to comply with all trial procedures. 2. **Age and Gender** - Aged between 30 and 65 years (inclusive), male or female. 3. **Reproductive Health Requirements** - Female participants: Negative serum pregnancy test. - Effective contraception for women of childbearing potential (e.g., hormonal, intrauterine device, or barrier methods). - Postmenopausal for at least 2 years, or history of hysterectomy, oophorectomy, or sterilization. - Male participants: No sperm donation or plans for conception within 30 days prior to the trial and 6 months post-trial, with effective contraceptive methods. 4. **Diagnostic Criteria** - Meets the diagnostic and classification criteria for **large artery atherosclerosis (LAA) subtype** of acute ischemic stroke as defined by the *Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018*. - Confirmed via neuroimaging (CT or MRI) as **unilateral cortical/subcortical ischemic infarction** caused by middle cerebral artery (MCA) or lenticulostriate artery occlusion. 5. **Post-Stroke Characteristics** - Onset of ischemic stroke within **6–60 months**, accompanied by **unilateral limb motor dysfunction** (with or without aphasia). 6. **Functional Assessment** - Modified Rankin Scale (mRS) score of **2, 3, or 4**. 7. **Fugl-Meyer Motor Assessment** - Two preoperative evaluations (>=3 weeks apart) show **Fugl-Meyer Motor Scale scores =3 weeks apart) show **NIHSS score change <4 points**. 9. **Postoperative Rehabilitation** - Willingness and ability to undergo **postoperative physiotherapy and rehabilitation therapy**.
Exclusion criteria
Exclusion criteria: 1. **Psychiatric or mental disorders** that may interfere with the study. 2. **History of more than one symptomatic cerebral stroke**, excluding transient ischemic attack (TIA). 3. **Signs or symptoms of intracranial herniation or elevated intracranial pressure**. 4. **History of epilepsy or concurrent use of antiepileptic drugs (AEDs)**. 5. **Cerebrovascular abnormalities or conditions**, including: - Intracranial aneurysm or arteriovenous malformation (AVM). - Hemorrhagic transformation of ischemic infarction. - Moyamoya disease (MMD). - Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL). - Massive cerebral infarction (MRI-confirmed infarct volume >150 cm³). - Preoperative magnetic resonance angiography (MRA) or computed tomography angiography (CTA) revealing **>50% stenosis** in intracranial or cervical vessels. 6. **Neurological disorders or anatomical deformities** causing severe unilateral motor impairment, such as: - Parkinson’s disease, motor neuron disease, arthritis, etc.. - Major surgery within 8 weeks prior to screening. 7. **Severe muscular atrophy or muscular dystrophy**. 8. **Severe cardiovascular diseases within 3 months**, including: - Malignant arrhythmia, atrial fibrillation, acute myocardial infarction, or congestive heart failure (NYHA class III-IV). 9. **Participation in other drug/device clinical trials** within 3 months (or 5 half-lives of the drug, whichever is longer). 10. **Prior cell infusion therapies** (excluding blood transfusion) within 5 years. 11. **Any of the following conditions**: a. **Coagulopathy** (preoperative INR >1.4). b. **Positive preoperative HLA1 or HLA2 antibodies**. c. **Poorly controlled severe active infection**. d. **Severe dermatitis or skin lesions at the surgical site**. e. **History of malignancy** (excluding benign tumors), including cerebral tumors (e.g., meningioma). f. **Abnormal laboratory values**: - Hemoglobin 2×ULN - Serum creatinine >1.2×ULN. g. **Uncontrolled hypertension** (SBP >160 mmHg or DBP >100 mmHg) or hypotension requiring vasopressors. h. **Poorly controlled diabetes** (HbA1c >8%). i. **Active gastrointestinal bleeding**. j. **Active or latent tuberculosis infection**. k. **Active hepatitis B** (HBsAg-positive) with HBV DNA >=ULN or requiring antiviral therapy; resolved HBV infection (HBsAg-negative, HBcAb-positive) is permissible if HBV DNA <ULN. l. **HCV antibody positivity**. m. **Syphilis infection** (positive treponemal serology requires confirmatory non-treponemal testing). n. **HIV antibody positivity**. 12. **Primary/secondary immunodeficiency** or conditions requiring immunosuppressive agents. 13. **Contraindications to cyclosporine, methylprednisolone sodium succinate, or prednisone**. 14. **Persistent MRI artifacts** or contraindications to MRI/PET imaging. 15. **Non-compliance** with rehabilitation, follow-up, or informed consent procedures. 16. **Inability to discontinue antiplatelet/anticoagulant drugs perioperatively** (defined as 3 days pre-surgery to 10 days post-surgery). 17. **Substance abuse, alcoholism**, or other conditions deemed high-risk by investigators. 18. **Study-related personnel** invol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerance 6 months after cell implantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerance 12 months after cell implantation;maximum tolerated dose; | — |
Countries
China
Contacts
Public ContactDai Yiwu
Neurosurgery Department of Seventh Medical Center, Senior Department of Neurosurgery, the First Medical Center of PLA General Hospital
Outcome results
None listed