- Article published online in American Journal of Nephrology; to be included in future print edition
“Renal autologous cell therapy, or REACT®, is a potentially groundbreaking treatment for CKD patients, a population in dire need of new, more effective therapeutic options,” said
The study is a prospective, multicenter, randomized control, open-label Phase II clinical trial that enrolled a total of 83 subjects ages 30-80 with Type 2 diabetic kidney disease. Following a kidney biopsy, subjects were randomized 1:1 to receive either active treatment with REACT® or optimized standard of care. Patients in the REACT® cohort receive two injections to be given six months apart in the same kidney that was biopsied. Subjects in the standard of care treatment arm receive optimal lifestyle and contemporaneous pharmacologic management of their disease (including SGLT2s, GLP-1, finerenone) for 12 months before crossing over to receive REACT® treatment. The primary safety endpoint is assessment of procedure- and REACT®-related adverse events through 24 months after the last REACT® dose. The primary efficacy endpoint is a measurement of estimated glomerular filtration rate (eGFR) from baseline through 24 months after the last REACT® dose. Additional information can be found at http://clinicaltrials.gov/ct2/show/NCT02836574.
About REACT®
REACT® has the potential to not only slow the progression of CKD, but in some cases drive meaningful improvement in kidney function – a groundbreaking first in CKD therapies.
A cell therapy product produced from a patient’s own kidney cells, REACT® comprises a proprietary mixture of progenitor cells that have been grown and selected, so they can be placed back into the patient’s kidney. This minimally invasive procedure, starting with a standard biopsy, provides the cells that harness the body’s intrinsic ability to repair and restore damaged kidney tissue. The outpatient reinjection procedure has been shown to be safer than contemporary biopsy and renal failure treatment options, such as dialysis and organ transplant.
About ProKidney
ProKidney, a pioneer in the treatment of chronic kidney disease (CKD) through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidney’s lead product candidate, REACT® (Renal Autologous Cell Therapy), is a first-of-its-kind, patented disease-modifying autologous cellular therapy with the potential to not only slow and stabilize the progression of CKD, but in some cases drive meaningful improvement in kidney function. REACT® has received Regenerative Medicine Advanced Therapy (RMAT) designation, as well as FDA and EMA guidance, supporting an immediate start to its Phase 3 clinical program, which launched on schedule in
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Source: ProKidney
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