ProKidney’s technology has the potential to restore kidney function by using the patient’s own (autologous) kidney cells, to possibly avoid or delay the need for renal replacement therapy, including dialysis or transplantation. Given patients receive cells originating from their own body, there is no need for immunosuppression.
ProKidney’s patented technology uses multiple breakthroughs in the manufacturing automation, supply chain, and medical delivery of cellular therapy products. While it has long been held that the body contains cells with regenerative potential, ProKidney’s technology seeks to identify these cells and harness them to restore function lost due to chronic diseases.
ProKidney’s innovative investigational therapy begins when tissue from a standard biopsy of the diseased kidney is sent to the ProKidney manufacturing facility. ProKidney expands and isolates the patient’s renal cells and formulates them into a personalized cell therapy product that is re-injected into the damaged kidney to assess whether the investigational cell therapy can repair damaged tissue or restore kidney function.
Preclinical studies in animal models have suggested that selected renal cells can integrate into the damaged kidney tissue and improve both renal function and histopathology, as illustrated in steps 5-7 below, as well as the two diagrams that follow. The mechanism by which SRCs mediate the improvement may be driven by impact on inflammation, fibrosis and tissue remodeling. The selected renal cells that comprise the REACT admixture are primarily comprised of epithelial cells derived from the glomerulus and proximal tubule.
Preliminary Safety Profile
REACT appears to be well tolerated in patients injected to date, and the REACT safety profile will continue to be closely monitored in ongoing clinical trials. There have been no identified adverse reactions shown to be related to the investigational cell therapy product.