Safety and Efficacy of CG-BM1 in Ischemic Stroke

Korábbi kezelés

• Previous stroke was of cardioembolic type.
• Deep vein thrombosis at screening or history of pulmonary embolism within 3 months before screening.
• Participation in another interventional clinical trial within 3 months or 5 half-lives (for investigational drug interventions only, whichever is longer) before infusion.

Más betegség

• History of cerebral hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation.
• History of epilepsy at any time or at screening, or current use of antiepileptic drugs.
• History or presence at screening of other neurological, psychiatric, joint, or muscle diseases that affect compliance or assessment.
• Malignancy within the past 5 years or at screening (except any cured malignancy with no evidence of tumor recurrence).
• Pulmonary hypertension (World Health Organization \[WHO\] functional class III or IV) at screening.
• History of myocardial infarction within 6 months.
• Positive human immunodeficiency virus (HIV) test or diagnosis of syphilis at screening; immunodeficiency disease; or long-term or short-term high-dose immunosuppressant or systemic corticosteroid therapy before screening.
• High risk of stroke recurrence as assessed by the investigator, or Essen Stroke Risk Score ≥5.
• Known allergy to any known component of the study drug.
• History of drug abuse or alcoholism within the past year.
• Contraindications to MRI or inability to cooperate with MRI examination (e.g., cardiac pacemaker, claustrophobia).

Laborértékek

• Uncontrolled systemic diseases, including but not limited to: hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg); diabetes mellitus (acute diabetic complications within 3 months, such as ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis, or hypoglycemic coma, or HbA1c \>8.5%); renal disease (eGFR \<30 mL/min); hepatic failure (Child-Pugh class C); severe heart failure (New York Heart Association \[NYHA\] class IV); severe chronic respiratory disease.
• Abnormal laboratory findings at screening as follows: hemoglobin \<90 g/L, absolute neutrophil count \<2.0×10\^9/L, platelet count \<100×10\^9/L, absolute lymphocyte count \<0.8×10\^9/L.

Egyéb

• Presence of pressure ulcers at screening.
• Expected survival \<12 months.
• Pregnant or breastfeeding; unwilling to use reliable contraception during the study (e.g., condoms); planning to donate sperm or oocytes; or planning to conceive.
• Participation in a stem cell clinical trial within 2 years.
• Any other factor that, in the investigator's judgment, makes the participant unsuitable for this study.

• Age ≥18 years; male or female.
• 3 to 60 months after onset of ischemic stroke.
• Screening imaging shows ischemic stroke consistent with anterior circulation infarction, with no new infarct lesions.
• Currently receiving standard medical therapy for secondary prevention of stroke.
• Modified Rankin Scale (mRS) score 3-4.
• National Institutes of Health Stroke Scale (NIHSS) score 6-20, with item 1a \<2.
• Willing to participate in the clinical trial; the participant or legal guardian signs the informed consent form and is willing to comply with all study procedures.