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A Preclinical Trial of Therapeutic Angiogenesis Plus Angioplasty and Stenting for Renal Vascular Disease

A Preclinical Trial of Therapeutic Angiogenesis Plus Angioplasty and Stenting for Renal Vascular Disease
治疗性血管生成加血管成形术和支架置入术治疗肾血管疾病的临床前试验
批准号:
9249339
负责人:
Gene Leflore Bidwell
金额:
$21.64万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2017
资助国家:
美国
项目状态:
已结题
起止时间:
2017-04-01 至 2019-03-31
关键词:
3-DimensionalAdverse effectsAffectAffinityAngioplastyAngiotensinsArchitectureBindingBiological AvailabilityBiological ProductsBiomedical EngineeringBiopolymersCarrier ProteinsCessation of lifeChemistryChimeric ProteinsChronicChronic Kidney FailureClinicalCollectionDepositionDeteriorationDialysis procedureDiseaseDoseDrug CarriersElastinEnd stage renal failureEngineeringFamily suidaeFibrosisFutureGeneral PopulationGlomerular Filtration RateGoalsGoldGrowthGrowth FactorHalf-LifeHealth Care CostsHospitalizationHumanIn VitroInfusion proceduresInjuryInterventionKidneyKidney DiseasesLeadLicensingLife ExpectancyLinkMediatingMicrocirculationModelingMorbidity - disease rateMusMyocardial InfarctionNOELNaturePatientsPerformancePharmaceutical PreparationsPharmacologic SubstancePharmacotherapyPhasePlasmaPredispositionPrevalenceProductionProteinsRecombinantsRecoveryRenal Artery StenosisRenal Blood FlowRenal Cell CarcinomaRenal Vascular DisorderRenal functionResolutionRiskSafetyScheduleSignal TransductionSmall Business Technology Transfer ResearchStentsStrokeTechnologyTestingTherapeuticTimeTissuesToxic effectToxicologyTreatment EfficacyTubular formationUnited StatesVEGFA geneVascular Endothelial Growth FactorsX-Ray Computed Tomographyangiogenesisbiomaterial compatibilitycardiovascular risk factorcommercializationdensityefficacy testinghemodynamicshuman diseaseimmunogenicityimprovedin vivokidney vascular structuremortalitynovelnovel therapeutic interventionnovel therapeuticspatient populationpeptide drugphase 1 studyphase 2 studypolypeptidepre-clinicalpreclinical efficacypreclinical evaluationpreclinical safetypreclinical trialresidenceresponsesmall moleculestandard of caretherapeutic angiogenesistherapeutic developmenttumor growth

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英文摘要
Abstract. Chronic kidney disease (CKD) is a progressive disorder affecting almost 14% of the general population, and this disease has shown a relentless growth over the past 2 decades. Patients with CKD have higher rates of hospitalization, greater mortality, shorter life expectancy, and their healthcare costs are up to 5 times more expensive than non-CKD patients. Thus, treatments to slow, halt, or reverse the progression of CKD could have a significant financial and clinical impact. Chronic renal vascular disease (RVD), often associated with renal artery stenosis, can deteriorate renal function and lead to CKD and end-stage renal disease in up to 15% of patients. Despite the availability of treatments for RVD including drugs and percutaneous transluminal renal angioplasty (PTRA), renal function does not improve or even deteriorates in over half of the patients undergoing these treatments. Leflore Technologies has developed a biopolymer-stabilized form of vascular endothelial growth factor (VEGF) with high renal binding. This Phase I STTR will test the feasibility of PTRA and stenting plus therapeutic renal angiogenesis with our biopolymer-stabilized VEGF in a preclinical trial using a swine model of chronic RVD. Recently, we have demonstrated that our biopolymer fusion greatly stabilizes the growth factor from degradation and plasma or tissue clearance and mediates deposition in the kidney following intrarenal administration. Furthermore, we have compelling preliminary evidence that our biopolymer- delivered VEGF is highly efficacious for restoring renal function in the swine model. The proposed Phase I studies will carry out preclinical efficacy and safety trials of PTRA and stenting in combination with our biopolymer-delivered VEGF compared to PTRA and stenting alone or PTRA and stenting with standard of care pharmacotherapy. These studies will examine the efficacy of this strategy relative to current clinical standard of care, the efficacy of this strategy at early-, middle-, and late-stage RVD, and the long-term efficacy and safety of the intervention. Future Phase II studies will involve good manufacturing and practice (GMP) production of our recombinant biological agent; chemistry, manufacturing and controls testing; and expanded preclinical IND-enabling toxicology.
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Renal Therapeutic Angiogenesis Using the Novel Biologic ELP-VEGF
  • 批准号:
    10547049
  • 项目类别:
  • 资助金额:
    $87.65万
  • 财政年份:
    2017
  • 负责人:
    Gene Leflore Bidwell
  • 依托单位:
Renal Therapeutic Angiogenesis Using the Novel Biologic ELP-VEGF
  • 批准号:
    10705193
  • 项目类别:
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  • 财政年份:
    2017
  • 负责人:
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  • 依托单位:
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  • 批准号:
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  • 项目类别:
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  • 财政年份:
    2014
  • 负责人:
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  • 依托单位:
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  • 批准号:
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  • 项目类别:
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  • 财政年份:
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  • 负责人:
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  • 依托单位:
海外基金