ProKidney is a late clinical-stage biotechnology company that is pioneering the development of a novel cell therapy candidate known as rilparencel, aimed at transforming the treatment landscape for advanced Chronic Kidney Disease (CKD). This investigational therapy is designed to preserve kidney function by stabilizing the estimated glomerular filtration rate (eGFR) or slowing its decline in patients suffering from CKD, particularly those with type 2 diabetes, which is a leading cause of the disease. Rilparencel is derived from the patient's own kidney cells, allowing for a minimally invasive percutaneous injection that eliminates the need for lifelong immunosuppressive therapy typically required for transplanted organs. Early clinical data suggest that rilparencel may not only delay the progression of CKD but also potentially reduce or eliminate the necessity for dialysis in affected patients.

The clinical development of rilparencel is currently in Phase 3 trials, with studies being conducted across approximately 150 clinical sites globally. ProKidney's approach emphasizes a robust manufacturing process and quality control to ensure the safety and efficacy of the cell therapy. The company has developed specialized production methods and analytical testing programs to meet the stringent requirements of Good Manufacturing Practice (GMP). With a focus on addressing the significant unmet medical need for effective CKD treatments, ProKidney aims to provide a viable alternative for the millions of patients facing limited options as they progress toward end-stage kidney disease.

United States

ProKidney Corp., a clinical-stage biotechnology, engages in developing cellular therapy candidates. It is developing Renal Autologous Cell Therapy, an autologous homologous cell admixture that is in a Phase III development program, as well as Phase II clinical trials for the treatment of moderate to severe diabetic kidney disease; and Phase I clinical trial for patients with congenital anomalies of the kidney and urinary tract. The company was founded in 2015 and is headquartered in Winston-Salem, North Carolina.

Central Nervous System (CNS)

Endocrine System Diseases

Metabolic Diseases

ProKidney

Chronic kidney disease

Type 2 diabetes

<p class="font_8">REACT, an autologous homologous cell admixture, is made from &nbsp;expanded autologous SRCs, obtained from each individual subject’s kidney &nbsp;biopsy. To manufacture REACT, biopsy tissue from each enrolled subject &nbsp;will be sent to ProKidney, in whose facilities renal cells will be &nbsp;expanded and SRCs selected. SRCs are then formulated into the &nbsp;cryopreserved or gelatin-based hydrogel product at a concentration of &nbsp;100 x 106 cells/mL, and shipped to the clinical site.</p>

ProKidney

Company Details