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. (6th June 2020)

• Record Type: Journal Article
• Authors: Yang, Chihchao; Li, Yi-Chen; Yip, Honkan
• Is Part Of: Nephrology dialysis transplantation. Volume 35(2020)Supplement 3
• Publication Date: 2020-06-06
• Subjects: Nephrology -- Periodicals; Hemodialysis -- Periodicals; Kidneys -- Transplantation -- Periodicals; Hemodialysis; Kidneys -- Transplantation; Nephrology; Periodicals; 616.61
• DOI: 10.1093/ndt/gfaa142.P0182
• Languages: English
• ISSNs: 0931-0509

Abstract

Abstract: 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<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<0.001) among the TG patients. The baseline EPC populations did not differ between TG and CG (p>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>0.1). Conclusion: CD34+ cell therapy was safe and improved one-year outcome.