ProKidney is developing rilparencel, an investigational cell therapy product designed to preserve kidney function by stabilizing estimated glomerular filtration rate (eGFR) in patients with advanced CKD.
Rilparencel is being developed to potentially delay or prevent the need for dialysis. Rilparencel is a percutaneous, minimally invasive injectable product prepared from the patient’s own kidney cells. Because rilparencel is prepared from the patient’s own cells, immunosuppressive therapy to prevent rejection is not required.
To date, clinical studies suggest that treatment with rilparencel in patients with advanced CKD and diabetes may positively impact kidney function by stabilizing eGFR or attenuating the rate of eGFR decline.
Over 35 million patients in the U.S. are living with CKD
Type 2 diabetes is the leading cause of CKD in the United States accounting for over 40% of new CKD patients, and therapeutic options to slow the progression of advanced CKD are limited. ProKidney is currently conducting a registrational Phase 3 trial of rilparencel in patients with advanced CKD and type 2 diabetes. Previous clinical studies suggest that rilparencel is well-tolerated and has the potential to stabilize kidney function.
Our Product Candidate
Our Approach
ProKidney’s dedicated team of cell therapy scientists and engineers have developed production methods to meet the requirements of the clinical programs. A product-specific analytical testing program has been designed, and assays have been qualified, to ensure product quality is prioritized. Process development strategies are implemented to gain efficiency while maintaining safety and quality profiles.
Process Development
Process development is a highly complex task requiring custom-developed solutions for cell-based products. Successful process development can, therefore, only be achieved through the application of extensive experience and expertise in all aspects of GMP manufacturing and quality control. The collective experience gained over a decade provides us with deep process development and analytical knowledge, enabling the implementation of robust manufacturing solutions that we utilize in developing our products.
