Safety and Early Effect of CG-BM1 for Ischemic Stroke
Official title: 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
Run by GuangZhou Cellgenes Biotechnology Co., Ltd. · NCT07896941 · Data updated 2026-11-12
This trial tests whether a single infusion of CG-BM1 is safe and may help people who recently had an ischemic stroke.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 87 (estimated) |
| Sponsor | GuangZhou Cellgenes Biotechnology Co., Ltd. Industry-sponsored |
| Locations | 1 site (Guangzhou) |
| Status | Recruiting |
| Started | September 30, 2024 |
| Main results expected | December 30, 2028 |
| Study ends | December 30, 2029 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07896941 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with ischemic stroke in the anterior circulation, 3–60 months from onset, mRS 3–4 and NIHSS 6–20, already on standard secondary prevention.
✕Probably not a fit
Patients without anterior circulation ischemic stroke or with more severe/less severe deficits, or those outside the post-stroke time window, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study combines Phase 1 and Phase 2 to evaluate CG-BM1 in adults who have had an ischemic stroke within the last 3 to 60 months. Participants receive varying cell doses as a single infusion, or repeated doses every two weeks for a total of three administrations, alongside standard secondary prevention therapy. Primary focus is safety and tolerability, with preliminary signals of effectiveness as secondary outcomes. The study will monitor adverse events, tolerability, and early functional indicators, using standard stroke scales.
Why it matters
Potential benefit: If successful, CG-BM1 could improve safety profiles and potentially aid in neurological recovery after ischemic stroke.
How similar studies have gone: Previous studies with cell-based approaches in stroke have shown variable safety and some signals of improvement; this design aims to build on that with CG-BM1.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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 ≥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. * 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 \<2.0×10\^9/L, platelet count \<100×10\^9/L, absolute lymphocyte count \<0.8×10\^9/L. * High risk of stroke recurrence as assessed by the investigator, or Essen Stroke Risk Score ≥5. * 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.
Where it's running
-
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China Recruiting
Study contacts
- Study coordinator: Zeng Liping, Senior Medical Director
- Email: Ip.zeng@cellgenes.com
- Phone: +86 20 82514048
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.