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Background and Aims This was a randomized, open-label, controlled phase II clinical trial to investigate the safety, efficacy and the outcomes of intra-renal artery (RA) infusion of autologous peripheral-blood-derived CD34+ cells for chronic kidney disease (CKD) (i.e., stage III or IV) patients. Method Between December 2016 and November 2018, 52 consecutive patients with CKD at stage III or IV were randomly allocated into treatment group (TG) (2.5 × 107 cells for each RA; n=26) and control group (CG) (standardized pharmacotherapy only; n=26). The primary endpoints included safety and change of creatinine level/creatinine clearance (Ccr). The secondary endpoints were 12-month combined unfavorable clinical outcomes (defined as dialysis or death), improvement in proteinuria, and CD34+cell-related adverse events. Results All patients were uneventfully discharged after CD34+ cell therapy. Flow cytometric analysis showed increases in circulating EPC (i.e., CD34+KDR+CD45dim/CD34+CD133+ CD45dim/CD31+CD133+CD45dim/CD34+CD133+KDR+/CD133+) and hematopoietic stem cell (HSC) (CD34+) populations after G-CSF treatment. Besides, Matrigel assay of angiogenesis was also significantly enhanced (all p&amp;lt;0.001). Renal vein blood samplings (i.e., at 0/5/10/30 min after CD34+ cell infusion) demonstrated significant progressive increases in EPC level (p for trend&amp;lt;0.001) among the TG patients. The baseline EPC populations did not differ between TG and CG (p&amp;gt;0.5). One-year combined unfavorable clinical outcomes were significantly lower in TG than those in CG [0% (0) vs. 13.3% (4), p=0.038](Figure). By 12-month after CD34+ cell therapy, circulating creatinine level, ratio of urine protein to urine creatinine, and creatinine clearance did not differ between TG and CG (all p&amp;gt;0.1). Conclusion CD34+ cell therapy was safe and improved one-year outcome.

nephrology, dialysis, transplantation/nephrology dialysis transplantation

P0182SAFETY AND EFFICACY OF INTRA-RENAL ARTERIAL AUTOLOGOUS CD34+ CELL TRANSFUSION IN PATIENTS WITH CHRONIC KIDNEY DISEASE: A RANDOMIZED, OPEN-LABEL, CONTROLLED PHASE II CLINICAL TRIAL