biostudies-literaturePerico NFondazione Regionale per la Ricerca BiomedicaHorizon 2020 Framework ProgrammeMedical Research CouncilHealth Research BoardPublic Health AgencyScience Foundation Ireland Research Centres1733-1751https://www.ebi.ac.uk/biostudies/studies/S-EPMC10561817biostudies-literatureUnknown34(10)<h4>Significance statement</h4>Mesenchymal stromal cells (MSCs) may offer a novel therapy for diabetic kidney disease (DKD), although clinical translation of this approach has been limited. The authors present findings from the first, lowest dose cohort of 16 adults with type 2 diabetes and progressive DKD participating in a randomized, placebo-controlled, dose-escalation phase 1b/2a trial of next-generation bone marrow-derived, anti-CD362 antibody-selected allogeneic MSCs (ORBCEL-M). A single intravenous (iv) infusion of 80×10 6 cells was safe and well-tolerated, with one quickly resolved infusion reaction in the placebo group and no subsequent treatment-related serious adverse events (SAEs). Compared with placebo, the median annual rate of decline in eGFR was significantly lower with ORBJournal of the American Society of Nephrology : JASNSafety and Preliminary Efficacy of Mesenchymal Stromal Cell (ORBCEL-M) Therapy in Diabetic Kidney Disease: A Randomized Clinical Trial (NEPHSTROM).PMC10561817MC_PC_15025STL/4760/13CTN-2021-006CP2_10/2018CRFC-2021-00163408613/RC/2073_P2Connolly LRota SFinnerty AAFibbe WEIntrona MWoods JKirkham KRuggenenti PLIslam MNWieles BSuresh VDavey GHayat ABaila SHolohan MLittle MSweetnam MO'Flynn LHanson ABarbui AMTodeschini MFifer LKuningas KPerico NDuffy AMurray HO'Brien TMessa PCasiraghi FMagee BAGotti ERoelofs HMariani SBorleri GWalmsley-Allen NGolay JDevaney NFerrari SHennessy MPortalupi VChan JAsbagh LARambaldi ANaughton SCarrara FEvans FDiadei OAtchinson LNatali GDesai ARice BHyatt APedrini OHanson VCormican SElliman SJBuckley JGiuliano GAPhan CGriffin MDSteeneveld EKrawczyk JChanouzas DWhite SCapelli CRubis NBoccardo PDuggan MMister MPeracchi TClissmann CKelly CPerna ARemuzzi GCreane MNEPHSTROM Trial ConsortiumMcInerney VMartyn SVilla AStucchi NMaxwell APSmythe JCappelletti LPerticucci EMartinetti DGritti GTarpey MGriffin TPCockwell PCugini DAusten EYap CShimizu YNoreiko OfalseSafety and Preliminary Efficacy of Mesenchymal Stromal Cell (ORBCEL-M) Therapy in Diabetic Kidney Disease: A Randomized Clinical Trial (NEPHSTROM).<h4>Significance statement</h4>Mesenchymal stromal cells (MSCs) may offer a novel therapy for diabetic kidney disease (DKD), although clinical translation of this approach has been limited. The authors present findings from the first, lowest dose cohort of 16 adults with type 2 diabetes and progressive DKD participating in a randomized, placebo-controlled, dose-escalation phase 1b/2a trial of next-generation bone marrow-derived, anti-CD362 antibody-selected allogeneic MSCs (ORBCEL-M). A single intravenous (iv) infusion of 80×10 6 cells was safe and well-tolerated, with one quickly resolved infusion reaction in the placebo group and no subsequent treatment-related serious adverse events (SAEs). Compared with placebo, the median annual rate of decline in eGFR was significantly lower with ORB2023-01-01T00:00:00Z2023 Oct2026-06-13T05:35:08.11Z2026-06-13T03:09:21.718ZS-EPMC105618173756096710.1681/ASN.0000000000000189