ProKidney’s technology has the potential to preserve kidney function by using the patient’s own (autologous) kidney cells to potentially avoid or delay the need for dialysis. Given rilparencel is prepared from a patient’s own cells, immunosuppressive therapy is not required.
Addressing Unmet Need in Advanced Kidney Disease
Not All Cell Therapies Are Created Equal
Rilparencel is a minimally invasive injectable product formulated from the patient’s own (autologous) kidney cells, which are then reinjected into the diseased kidney. The cells formulated in rilparencel are believed to utilize innate kidney repair mechanisms that remain active in a chronically diseased kidney, thereby preserving kidney function.
As a personalized (autologous) cell therapy prepared from the patient’s own cells, rilparencel may ease the treatment burden for CKD patients: requiring no pre-treatment therapy (as other cell/gene therapies often do); and no immunosuppressive therapy to prevent rejection.
Clinical Progression: From Proof of Concept to Pivotal Evidence
Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA), a status granted to accelerate the development and review of promising regenerative medicine therapies.
Based on a robust body of clinical evidence supporting its safety profile and potential to positively impact kidney function, ProKidney has advanced rilparencel into a registrational Phase 3 clinical trial (REGEN-006, or PROACT 1) in patients with Stage 3b/4 CKD and type 2 diabetes.
