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โ† Trials
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Safety and Efficacy of CG-BM1 in Ischemic Stroke

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllGuangZhou Cellgenes Biotechnology Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

1. To evaluate the safety and tolerability of CG-BM1 for the treatment of patients with Ischemic Stroke. 2. To observe the preliminary effectiveness of CG-BM1 in treating Ischemic Stroke patients.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 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. Exclusion Criteria: * History of cerebral hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation. * Previous stroke was of cardioembolic type. * Presence of pressure ulcers at screening. * 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. * Uncontrolled systemic diseases, including but not limited to: hypertension (systolic blood pressure โ‰ฅ160 mmHg and/or diastolic blood pressure โ‰ฅ100 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. * Deep vein thrombosis at screening or history of pulmonary embolism within 3 months before screening. * 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. * Abnormal laboratory findings at screening as follows: hemoglobin \<90 g/L, absolute neutrophil count \<2.0ร—10\^9/L, platelet count \<100ร—10\^9/L, absolute lymphocyte count \<0.8ร—10\^9/L. * High risk of stroke recurrence as assessed by the investigator, or Essen Stroke Risk Score โ‰ฅ5. * 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 another interventional clinical trial within 3 months or 5 half-lives (for investigational drug interventions only, whichever is longer) before infusion. * Participation in a stem cell clinical trial within 2 years. * 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). * Any other factor that, in the investigator's judgment, makes the participant unsuitable for this study.
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What it tests

  • single infusion, 1.0 ร— 10^6 cells/kg
  • single infusion, 2.0 ร— 10^6 cells/kg
  • single infusion, 3.0 ร— 10^6 cells/kg
  • 1.0 ร— 10^6 cells/kg once every two weeks for a total of 3 doses
  • 2.0 ร— 10^6 cells/kg once every two weeks for a total of 3 doses
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Where

1 site
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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