Hemorrhagic stroke
Conditions
Interventions
neural stem cell group(Low dose):Low dose neural stem cells
neural stem cell group(High dose):High dose neural stem cells
Placebo group:Placebo
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) aged 18-85 years, male or female; (2) dlinical diagnosis of hemorrhagic stroke; (3) moderate to severe stroke with motor or language defects, (NIHSS) score of NIH stroke scale >= 6, corrected Rankin score between 2 and 4; (4) study intervention was given from 6 months to 1 year after stroke; (5) the cerebral hemorrhage was confirmed to be located in one hemisphere by CT or MRI scan. (6) one neurosurgical operation of intracerebral hematoma, basic neurosurgical treatment and / or rehabilitation treatment; (7) women are not pregnant, are not breastfed and are not planned to become pregnant during the study period; if they are fertile, they must agree to use effective contraceptives during the trial period; (8) the patient or legal representative signs an informed consent form; (9) be willing and able to comply with the treatment and related examinations of the Institute; (10) be willing and able to return to the trial site for post-treatment evaluation.
Exclusion criteria
Exclusion criteria: (1) CT or MRI showed that the current stroke was caused by brainstem hemorrhage. (2) cerebral hemorrhage caused by head injury or tumor; (3) past history of cerebral infarction; (4) history of allergy; (5) the evaluation of focal neurological impairment in the ipsilateral brain was too complicated. (6) abnormal structure and function of nasal cavity, such as nasal polyps, tumor, sinusitis, etc., affect nasal administration; (7) prolonged history of arrhythmia or QTc with clinical significance; (8) complicated with chronic diseases such as liver or renal dysfunction; (9) Coagulation disorder; (10) current or previous cell therapy (except for blood transfusions); (11) suffering from Alzheimer's disease or other dementia, Parkinson's disease, Huntington's disease or any other neurological disease that may affect their participation in experiments or confusing research assessments; (12) other systemic diseases that limit motor function, such as neuromuscular or orthopedic diseases; (13) uncontrolled systemic diseases, including, but not limited to, diabetes, kidney, liver or heart failure; (14) having a history of any type of malignant tumor; (15) HIV infection; (16) substance use disorders (according to DSM-V standards, including drug or alcohol addiction); (17) contraindications to MRI, such as implantable pacemakers or other metal prostheses incompatible with MRI; (18) patients with other serious medical or mental illness that are not adequately controlled or whose researchers are unable to manage according to the programme; (19) there were other surgical history within 6 months; (20) allergic to human tissue or bovine or pig products; (21) in other cases, the doctor is of the opinion that it is not appropriate to participate in this clinical trial; (22) participate in any other trial of a drug preparation or device within 30 days prior to the treatment of the research product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main safety measures: incidence of adverse events (12 months);Main therapeutic indexes: NIHSS score (6 months).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Rankin score (mRS score) (1 month, 3 months, 6 months, 12 months);Barthel index (1 month, 3 months, 6 months, 12 months);MMSE score (1 month, 3 months, 6 months, 12 months);Changes of cranial MRI;Laboratory tests include basic routine and biochemical tests. Immunological examination, tumor markers, etc.; | — |
Countries
China
Contacts
Public ContactJianhong Zhu
Huashan Hospital, Fudan University
Outcome results
None listed