A phase 2 randomized trial with autologous polyclonal expanded regulatory T cells in children with new-onset type 1 diabetes
Bender C, Wiedeman A, Hu A, Ylescupidez A, Sietsema W, Herold K, Griffin K, Gitelman S, Long S, Gottlieb P, Strock R, Chesshir L, Redondo M, Williams C, Clements M, Moore W, DiMeglio L, Legge M, Mullen M, Sanchez J, Spall M, Woerner S, Gaglia J, Resnick B, Bryant N, Krishfield S, Turley J, Koshy N, Mackey M, Guttmann-Bauman I, Fitch R, Bartholow L, Shelso J, Al Nofal A, Hanisch K, Casas L, Thurlow B, Gottschalk M, Hashiguchi M, Paglia L, Lam A, Sanda S, Torok C, Wesch R, Moore D, Russell W, Smith T, Brown A, Brendle F, Haller M, Cintron M, Baidal D, Matheson D, Blaschke C, Moran A, Pappensus E, Leschyshyn J, Street A. A phase 2 randomized trial with autologous polyclonal expanded regulatory T cells in children with new-onset type 1 diabetes. Science Translational Medicine 2024, 16: eadn2404. PMID: 38718135, DOI: 10.1126/scitranslmed.adn2404.Peer-Reviewed Original ResearchConceptsRegulatory T cellsType 1 diabetesT cellsC-peptideFoxp3<sup>+</sup> regulatory T cellsNew-onset type 1 diabetesResidual B-cell functionPhase 1 clinical trialAutoimmune type 1 diabetesC-peptide preservationHigh-dose cohortPhase 2 randomized trialYears compared to placeboNew-onset T1DBaseline C-peptidePeripheral blood samplesSuppression in vitroDetected 1 weekMatching placeboAdoptive transferDouble-blindHigh-dosePrevent autoimmunityLow-doseFold expansionEarly Metabolic Endpoints Identify Persistent Treatment Efficacy in Recent-Onset Type 1 Diabetes Immunotherapy Trials.
Jacobsen L, Cuthbertson D, Bundy B, Atkinson M, Moore W, Haller M, Russell W, Gitelman S, Herold K, Redondo M, Sims E, Wherrett D, Moran A, Pugliese A, Gottlieb P, Sosenko J, Ismail H. Early Metabolic Endpoints Identify Persistent Treatment Efficacy in Recent-Onset Type 1 Diabetes Immunotherapy Trials. Diabetes Care 2024, 47: 1048-1055. PMID: 38621411, PMCID: PMC11294635, DOI: 10.2337/dc24-0171.Peer-Reviewed Original ResearchConceptsC-peptide area-under-the-curveArea under the curveC-peptideRecent-onset type 1 diabetesTreatment efficacyEarly-phase clinical trialsC-peptide preservationPrimary end pointB cell functionDetect treatment efficacyType 1 diabetesPost hoc analysisRandomized controlled trialsImmune therapyImmunotherapy trialsMonths posttherapyClinical trialsTreatment effectsEnd pointsMetabolic indicesHoc analysisControlled trialsType 1 diabetes trialsMetabolic endpointsIntervention trials
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