Long term outcomes of intra-carotid arterial transfusion of circulatory derived autologous CD34+ cells for acute ischemic stroke patients—A randomized, open-label, controlled phase II clinical trial

Abstract

Abstract Background This phase II randomized control trial tested whether intracarotid arterial administration of autologous CD34 + cells to the patients within 14 ± 7 days after acute ischemic stroke (IS) could be safe and further improve short- and long-term outcomes. Methods and Results Between January 2018 and March 2022, 28 consecutive patients were equally randomly allocated into group 1 (CD34 + cells/3.0 x 107/patient) and group 2 (received optimal-medical therapy). The CD34 + cells were transfused into the ipsilateral brain infarct zone of group 1 patients at catheterization room. The results demonstrated that safety and success of the procedure were 100% and no long-term tumorigenesis was observed in group 1 patients. In group 1 patients, the circulating EPC number/angiogenesis capacity were significantly higher at post than at prior to granulocyte-colony-stimulating factor treatment (all p < 0.001). Time courses of blood samplings from right-internal jugular vein of the group 1 displayed a significant increase in the levels of SDF-1α and EPCs in time points of 5/10/30 minutes than in that of 0 minute (all p < 0.005). The National Institute of Health Stroke Scale was similar upon presentation, whereas it showed a great response by days 30/90 and Tc-99m brain perfusion was significantly increased by 180-days after acute IS in group 1 than in group 2 (p = 0.046). The long-term (4.1 ± 1.3 years follow-up) combined end points (defined as death/recurrent stroke/or severe disability) were notably higher in group 2 than in group 1 patients (p = 0.103). Conclusion Intracarotid transfusion of autologous CD34 + cells was safe and might provide some benefits for acute IS patients. Clinical trial Registration number: ISRCTN15677760 (Registration date: 23/04/2018)