ProKidney Corp. announced the publication of the trial design and early data analysis from REGEN-003, a Phase 2 clinical study of Renal Autologous Cell Therapy (REACT(R)), in the Journal of Blood Purification. The paper, titled Renal Autologous Cell Therapy (REACT) in Type 2 Diabetes with Late Stage 4 Diabetes-Related Chronic Kidney Disease: Trial Design and Early Analysis, was published online and will appear later this year in the print edition of the Journal (DOI: doi.org/10.1159/000527582).

REGEN-003 is a single-arm, open-label, multicenter Phase 2 clinical trial that enrolled a total of ten adults with pre-renal failure resulting from type 2 DKD (kidney function measured by eGFR of 14-20 ml/min/1.73 m²). Following a percutaneous kidney biopsy and ex vivo expansion of Selected Renal Cells (SRCs) that form REACT, the REACT product was injected into the cortex of the biopsied kidney with CT image guidance. Nine participants received two doses of the REACT product at 6-month intervals; one participant received only one injection.

A 6-month observation pre-trial was required to establish patients' “own” baseline and rate of DKD progression. No product-related serious adverse events occurred, and two procedure-related hematomas required observation without transfusion or angiographic interventions. At the time of this early analysis, dialysis was delayed a mean of 16 months (range 6-28 months).

At 15 months, two patients (20%) had preservation of their kidney function and had not advanced to renal replacement therapy. One patient died due to complications related to COVID, and an additional subject died due to a myocardial infarction approximately 18 months after enrollment.