Hemiplegic sequelae following ischemic stroke
Conditions
Interventions
low-dose cohort:Multi-target intracerebral delivery of hNPC01 cells (3×10e6 total cells) via 15 precise injection points.
mid-dose cohort:Multi-target intracerebral delivery of hNPC01 cells (7.5×10e6 total cells) via 15 precise injection points.
high-dose cohort:Multi-target intracerebral delivery of hNPC01 cells (1.5×10e7 total cells) via 15 precise injection points.
sham operation group:skull trepanation without penetrating the dura mater
Sponsors
Neurosurgery Department of Seventh Medical Center, Senior Department of Neurosurgery, the First Medical Center of PLA Gene
Eligibility
Sex/Gender
All
Age
25 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Voluntarily participate in the clinical research and sign the informed consent form; (2) Aged 25 - 70 years old (inclusive of the boundary values), with no gender restriction, and voluntarily use contraception during the research and within half a year after the end of the research; (3) Meet the diagnostic criteria of Diagnosis and Treatment Guidelines for Acute Ischemic Stroke in China formulated by the Neurology Branch of the Chinese Medical Association, and be diagnosed with ischemic stroke through examinations such as head CT or magnetic resonance imaging, and belong to the subcortical ischemic infarction caused by the infarction of the unilateral middle cerebral artery and/or anterior choroidal artery; (4) 1 - 6 years after the first acute onset of ischemic stroke, accompanied by motor function impairment of one limb (if there is motor function impairment of both limbs, select the intracranial lesion corresponding to the side with more severe symptoms for surgery); (5) Modified Rankin Scale score of 2, 3 or 4; (6) The scores of the Fugl - Meyer Assessment of Motor Recovery after Stroke in two evaluations with an interval of at least 3 weeks before surgery are both lower than 55, and the change in scores between the two evaluations is not more than 5 points; (7) The change in scores of the National Institutes of Health Stroke Scale in two evaluations with an interval of at least 3 weeks before surgery is not more than 4 points; (8) Regularly receive physical therapy and rehabilitation treatment after the onset of ischemic stroke, and can and are willing to continue to receive physical therapy and rehabilitation treatment after being enrolled in the group.
Exclusion criteria
Exclusion criteria: (1) Those suffering from psychological or psychiatric diseases that can affect the research; (2) Those with a history of more than one symptomatic stroke in the past (based on the hospital examination results corresponding to more than one attack), excluding those with transient ischemic attack (TIA) and those without motor function impairment in the first attack; (3) Those with symptoms and signs of intracranial hernia or increased intracranial pressure; Those with a history of epilepsy or taking antiepileptic drugs at the same time; Those with severe muscular atrophy or muscular dystrophy; Those who have had severe cardiovascular diseases in the past 3 months; (4) Those with symptomatic large unremoved intracerebral aneurysms or arteriovenous malformations; Hemorrhagic transformation of ischemic infarction foci within 2 weeks before screening; Moyamoya disease (MMD); Autosomal dominant hereditary cerebrovascular disease with subcortical infarction and leukoencephalopathy; Participants with huge area cerebral infarction (MRI confirms that a single infarction area is greater than 150 cm³); Severe stenosis or occlusion of the internal carotid artery, bilateral vertebral arteries or basilar artery shown by preoperative head and neck vascular imaging; (5) Those with severe motor function impairment of one limb caused by previous neurological diseases such as Parkinson's disease, motor neuron disease, arthritis or anatomical deformity; Those with deep sensory dysfunction caused by reasons other than ischemic stroke, such as subacute combined degeneration (SCD) of the spinal cord, spinal cord trauma, lumbar disc herniation, nervous system damage related to alcohol/drug poisoning, etc.; Those who have received any major surgery within 8 weeks before screening; Those who have participated in other drug or device clinical trials in the past 3 months (or 5 half - lives of the drug, whichever is longer as the screening condition); Those who plan to participate in other drug or device clinical trials with similar treatment purposes before the end of the long - term follow - up of this trial (that is, within the next 5 years); Those who have received other cell infusions or similar treatments except blood transfusion in the past 5 years; Those with contraindications to the adjuvant drugs in this research; Those with contraindications to MRI or PET scanning; (6) Those with severe immunodeficiency; Those with severe coagulation dysfunction; Those with severe infection during the screening period; Those with severe dermatitis or skin lesions at the intended scalp incision site for cell implantation during the screening period; Those with malignant tumors; Those with uncontrolled or poorly controlled diabetes (glycated hemoglobin HbA1c > 8%), or uncontrolled or poorly controlled hypertension (systolic blood pressure > 160 mmHg, or diastolic blood pressure > 100 mmHg), or hypotension requiring pressor treatment, or severe active gastrointestinal bleeding; Those with serious abnormalities in important laboratory test items; Those who are active hepatitis B or hepatitis C ;Those who are HIV ; (7) Those judged by the researcher as not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerance 6 months after cell implantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| The improvement of the Fugl-Meyer Motor Function Scale at 6 months and 12 months after transplantation, respectively.;Safety and tolerance 12 months after cell implantation;evaluate the optimal biological 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