Safety and Preliminary Efficacy of Mesenchymal Stromal Cell (ORBCEL-M Cell) Therapy in Diabetic Kidney Disease: A Randomized Clinical Trial (NEPHSTROM).
Norberto PericoGiuseppe RemuzziMatthew D GriffinPaul CockwellAlexander Peter MaxwellFederica CasiraghiNadia RubisTobia PeracchiAlessandro VillaMarta TodeschiniFabiola CarraraBernadette A MageePiero L RuggenentiStefano RotaLaura CappellettiVeronica McInerneyTomás P GriffinMd Nahidul IslamMartino IntronaOlga PedriniJosée GolayAndrew A FinnertyJon SmytheWillem E FibbeStephen J EllimanTimothy O'Briennull nullPublished in: Journal of the American Society of Nephrology : JASN (2023)
Findings indicate safety and tolerability of intravenous ORBCEL-M cell therapy in the trial's lowest-dose cohort. The rate of decline in eGFR (but not mGFR) over 18 months was significantly lower among those receiving cell therapy compared with placebo. Further studies will be needed to determine the therapy's effect on CKD progression.