Renal Autologous Cell Therapy (REACT) to Stabilize Function
Chronic kidney disease (CKD) is a world-wide disease without cure. Selective renal cells (SRCs) can augment kidney function in animal models. Twenty-two adults with Type 2 D-CKD underwent a kidney biopsy followed by two subcortical injections of SRCs, 7±3 months apart. Two patients had only one injection. We compared annualized estimated glomerular filtration rate (eGFR) slopes pre- and post-REACT injection using the 2009 CKD-Epi formula for creatinine (sCr) and the 2012 CKD-EPI Creatinine-Cystatin C equation and report clinical/laboratory changes. Fluorescent Activated Cell Sorting Analysis for renal progenitor lineages in REACT and donor VEGF-A analysis was performed. Longitudinal parameter changes were analyzed with longitudinal linear mixed effects model.

At baseline, the mean diabetes duration of 18.4±8.80 years, HgbA1c 7.0±1.05, and eGFR of 40.3±9.35 mL/min/1.73 m2 using the 2012 CKD-EPI cystatin C and sCr formula. The annualized eGFR slope (2012 CKD-EPI) was -4.63 mL/min/1.73m2/year pre-injection and improved to -1.69 mL/min/1.73m2/year post-injection (p=0.015). Seven patients had an eGFR slope of >0 mL/min/1.73m2 post-injection. SRCs demonstrated cell markers of ureteric bud, mesenchyme cap, and podocytes sources and positive VEGF. Two patients had remote fatal adverse events determined as unrelated with the biopsies/injections or the REACT product.

Our cell marker analysis suggests SRCs may enable REACT to stabilize kidney function, possibly halting Type 2 D-CKD progression.