Bone Marrow Stem Cell Infusion for People With Ischemic Stroke

Trial details

Who runs it

GuangZhou Cellgenes Biotechnology Co., Ltd.

Trial code

NCT07896941

Record updated

28 October 2026

Original description

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.Read full original descriptionShow less

A Clinical Trial to Evaluate the Safety and Efficacy of Allogeneic Human Bone Marrow Mesenchymal Stem Cell (CG-BM1) Injection in the Treatment of Ischemic Stroke

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.

Inclusion: 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.

Exclusion: 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; 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); 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; 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.

ClinicalTrials.gov NCT07896941