Autologous cell therapy refers to the prevention or treatment of human disease by the administration of a person’s own cells that have been multiplied, selected and formulated for delivery outside the body. We believe that our technology has the potential to restore kidney function by using a patient’s own selected renal cells (SRCs).
Our investigational process to restore kidney function begins when a small biopsy of the diseased kidney is sent to our laboratory. We identify the patient’s healthy cells and formulate them into a personalized cell therapy product that is then re-injected into the damaged kidney to assess whether the investigational cell therapy can repair damaged tissue and / or restore kidney function.
To date, clinical studies suggest that treatment with REACT in patients with type 2 diabetes and CKD may positively impact renal function by stabilizing eGFR or attenuating the rate of eGFR decline. Preclinical studies indicate that REACT may migrate throughout the kidney, resulting in an improvement in renal function and histologic structure, including decreased interstitial fibrosis and inflammation.
ProKidney's REACT Renal Autologous Cell Therapy
REACT, an autologous homologous cell admixture, is made from expanded autologous SRCs, obtained from each individual subject’s kidney biopsy. To manufacture REACT, biopsy tissue from each enrolled subject will be sent to ProKidney, in whose facilities renal cells will be expanded and SRCs selected. SRCs are then formulated into the cryopreserved or gelatin-based hydrogel product at a concentration of 100 x 106 cells/mL, and shipped to the clinical site.
Our Product Candidate
REACT is currently in a Phase 3 development program for Diabetic Kidney Disease, as well as ongoing Phase 2 clinical trials. REACT is also currently in a Phase 1 clinical trial in patients with congenital anomalies of the kidney and urinary tract (CAKUT). These trials are being or will be conducted at over 150 clinical sites throughout the United States, Europe, Asia and Latin America.
The ongoing clinical development program utilizes a newly developed percutaneous injection method into the kidney that is conducted using conscious sedation in an outpatient same-day procedure. The safety profile of the REACT treatment procedure resembles the risk typically incurred with a routine kidney biopsy.