An open-label, blinded phase II study investigating the treatment of acute large hemispheric infarction by transcranial bone marrow injection of RK-4 injection For subjects with acute large hemispheric infarction who are contraindicated to vascular recanalization or have poor response to vascular recanalization therapy, the safety, tolerability, and PK characteristics of RK-4 injection injected into the brain cell marrow through the cranial bone marrow will be preliminarily evaluated, and the efficacy will be preliminarily explored. The main questions it aims to answer are:
* The efficacy of RK-4 injection injected into the brain cell marrow through the cranial bone marrow. * If drug RK-4 is safe and tolerate in the patients with LHI? Researchers will analyze data from different groups, includes cranial administration group and conventional treatment group , to see efficacy of RK-4 injection injected into the brain cell marrow through the cranial bone marrow and If drug RK-4 is safe and tolerate in the patients with LHI .
Participants will:
* Take drug RK-4 (2mg/mL, 1mL) by transcranial bone marrow injection once daily for consecutive 3 days or just receive conventional treatments. * Truthfully provide medical history and "previous participation in clinical trials" and a statement of no history of mental disorders. * Take the drug at the specified time every day according to the dosage prescribed by the doctor * Receive the investigational drug as instructed by the doctor and visiting as required * Tell the investigators about any medications (including chemicals, biological drugs, proprietary Chinese medicines, etc.) and related treatments you take during the study * unpermitted stop the investigational drug yourself at the end of the study or when you decide to withdraw from the study, you need to stop the investigational drug as directed by your doctor to ensure your safety * take reasonable contraception actions * unallowed to use unmarketed drugs or other clinical trial drugs during the study
16≤NIHSS score ≤32 points, sum of the fifth upper limb and sixth lower limb scores≥6;
Extended thrombolytic grading (eTICI) = 2a;
NIHSS score did not improve or progressed after vascular reperfusion treatment and the total score was still ≤ 32 points. Note: A decrease of 1 point or more is an improvement, and an increase of 1 point or more is progress. 6. Subjects or their legal representatives voluntarily sign the informed consent form.
Combined with acute cerebral hemorrhage and subarachnoid hemorrhage;
Combined with acute posterior circulation cerebral infarction, or severe posterior circulation vascular stenosis (>70%);
Imaging suggests bilateral involvement of the cerebral infarction area;
The cause has been diagnosed by TOAST typing before screening, and other etiologies such as intracranial artery dissection, vasculitis, and moyamoya disease have been identified
Parallel
RK-4 injection
Drugtake drug RK-4 (2mg/mL, 1mL) by transcranial bone marrow injection once daily for consecutive 3 days.
conventional treatment
Other interventionconventional treatment of LHI other than RK-4
The proportion of patients achieving mRS scores of 0-3 on day 90±7 of treatment.
The modified Rankin scale is used to measure the outcomes of patients' functional recovery after the stroke. It constitute of 0-6 scale, the higher the score is, the worse the motor function of the patient.
Evaluate the efficacy of RK-4 in patients with LHI by the change of NIHSS score on day 8±1 from baseline
NIHSS is a scale used to assess neurological function
Evaluate the efficacy of RK-4 in patients with LHI by the change of NIHSS score on day 14±1 from baseline
NIHSS is a scale used to assess neurological function
Evaluate the efficacy of RK-4 in patients with LHI by the proportion of NIHSS score improvement of ≥4 points on day 14±1 from baseline
NIHSS is a scale used to assess neurological function
Evaluate the efficacy of RK-4 in patients with LHI by the comparison of mRS score distribution on day 90±7
The modified Rankin scale is used to measure the outcomes of patients' functional recovery after the stroke. It constitute of 0-6 scale, the higher the score is, the worse the motor function of the patient.
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