grant
Developing autologous iPSC-RPE based IND for AMD patients
Organization NATIONAL EYE INSTITUTELocation UNITED STATES
NIHUS FederalResearch GrantFY2025AcuteAirAnimal ModelAnimal Models and Related StudiesAnimalsAtrophic AMDAtrophic age-related macular degenerationAutologousBiotechBiotechnologyBlebBlisterBody TissuesBullaBullous LesionCell TherapyChronicClinicalClinical ProtocolsCo-cultureCocultivationCocultureCoculture TechniquesCollaborationsDry AMDDysembryomaEarly-Stage Clinical TrialsEyeEyeballFDA approvedFamily suidaeGoalsHistologicHistologicallyHumanIND FilingIND applicationIND packageIND submissionIRBIRBsImmunocompromisedImmunocompromised HostImmunocompromised PatientImmunosuppressed HostInjectionsInstitutional Review BoardsInvestigational New Drug ApplicationLiquid substanceModelingModern ManNational Institutes of HealthNon-exudative age-related macular degenerationNonexudative age-related macular degenerationOncogenesisOperative ProceduresOperative Surgical ProceduresOrganOtomyPatientsPhasePhase 1 Clinical TrialsPhase I Clinical TrialsPhotoreceptor CellPhotoreceptorsPhotosensitive CellPigsProceduresProcessProductionProgenitor CellsProtocolProtocols documentationRetinaSafetySalineSaline SolutionSamplingSkinSuidaeSurgicalSurgical InterventionsSurgical ProcedureSurgical incisionsSwineTechnologyTeratoid TumorTeratomaTestingTherapeuticTimeTissuesTransplantationUnited States National Institutes of HealthVesicationVisual ReceptorVitrectomyWorkcell based interventioncell mediated interventioncell mediated therapiescell-based therapeuticcell-based therapycellular therapeuticcellular therapyclinical centerdry age-related macular degenerationefficacy testingfluidfull scale manufacturinghuman subjectiPSiPSCiPSCsimmunosuppressed patientincisioninduced pluripotent cellinduced pluripotent stem cellinducible pluripotent cellinducible pluripotent stem celllarge scale manufacturinglarge scale productionliquidmass productionmodel of animalparticipant enrollmentpatient enrollmentphase 1/2a trialphase I protocolphase I/IIa trialporcinepre-clinicalpre-clinical efficacypre-clinical safetypreclinicalpreclinical efficacypreclinical safetysafety assessmentscaffoldscaffoldingstem cellssuidsurgerytransplanttumorigenesis
Description preview
1. Production of GLP-grade iPSC lines and RPE from AMD patients.
Skin samples from three AMD patients were reprogrammed into GLP-grade iPSC lines and differentiated into RPE using a xeno-free medium. Generating lines from multiple patients demonstrated process consistency. The technology was successfully transferred to the NIH Clinical Center GMP…
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