Ultrasound Enhanced Low Dose Drug Delivery: Quantifying Uptake, Retention and Biodistribution
超声增强低剂量药物输送:量化摄取、保留和生物分布
基本信息
- 批准号:9548284
- 负责人:
- 金额:$ 38.17万
- 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
- 起止时间:2017-08-21 至 2022-01-31
- 项目状态:已结题
- 来源:
- 关键词:AcuteAddressAdoptionAffectAgingAmputationAngioplastyAreaArteriesBiodistributionBiologicalBloodBlood VesselsBlood flowCardiovascular DiseasesCathetersCell membraneCellsClinical TrialsCollaborationsComplicationCounselingDataDevelopmentDevicesDimensionsDiseaseDoseDrug ControlsDrug Delivery SystemsDrug KineticsDrug ModelingsEconomic BurdenElderlyEmbolismEvaluationFDA approvedFaceFamily suidaeFeedbackFormulationFosteringFundingFutureGoalsGrowthHemorrhageHistologicHyperplasiaImageInjuryInterventionIschemiaKidneyKneeLeadLimb structureLiverLocationLongevityLower ExtremityMeasuresMethodsMicrobubblesModelingModificationMuscleOperative Surgical ProceduresOrganOryctolagus cuniculusPaclitaxelPainPatientsPeripheralPeripheral arterial diseasePharmaceutical PreparationsPhasePhysiologicalPopulationPreparationPrevalenceRegulatory PathwayRiskSafetySeriesSmall Business Innovation Research GrantStenosisStentsSterilizationSubgroupSurgeonSystemTechniquesTechnologyTherapeuticThrombosisUltrasonographyantiproliferative drugsbasebiomaterial compatibilityburden of illnessclinical riskcommercializationcostdesignexperienceexperimental studyfemoral arteryimage guidedimaging systemimprovedin vivoinjuredinnovationinterestneointima formationnovelpreclinical studypreventradiologistrestenosisrestorationstandard of caresuccesssystemic toxicitytechnological innovationtreatment responseuptake
项目摘要
This Direct to Phase II SBIR project addresses the need for safe and effective drug delivery after lower
extremity angioplasty. Globally over 200 million people suffer from peripheral arterial disease (PAD). Both the
disease and economic burdens of PAD are projected to grow rapidly, with the US PAD population projected to
grow to 22M in 2020 as costs currently exceed $20B. The leading cause of this growth is an aging US
population that faces a disease whose prevalence increases with advancing age. In the advanced stages of
PAD, angioplasty, the expansion of an occluded artery, is the state of the art for treatment. However, the
lifespan of angioplasty can be as brief as 3 months in the periphery due to restenosis, the re-occlusion of the
blocked artery by the overgrowth of its own cells. As a result, it is recommended that interventionalists wait to
perform angioplasty on patients until the onset of critical limb ischemia (CLI), a catastrophic vessel blockage
that results in severe pain and can lead to amputation.
In order to address these needs, SoundPipe is commercializing a platform to deliver drugs that can prevent
restenosis, the Guidance by Ultrasound Imaging and Delivery Enhancement of Therapeutics (GUIDE-Tx)
system. This novel catheter-based system uses ultrasound to simultaneously image the vasculature and
enhance delivery of restenosis preventing drugs after angioplasty. The drugs are carried by microbubbles
ejected from the tip of the catheter where they are guided to a precise location by intravascular ultrasound.
There, under ultrasound image guidance, the ultrasound and microbubbles enhance permeabilization of the
cell membrane and release the drug from the microbubbles. This technique controls drug dose and spatial
coverage, providing a versatile method for preventing restenosis after angioplasty. SoundPipe’s technology will
improve angioplasty by: 1) allowing the interventionalist to control drug dose, type, and coverage and 2)
offering image guidance during drug delivery. The added versatility will foster innovation in the field of
intravascular drug delivery.
This Direct to Phase II SBIR will use a series of in vivo swine and rabbit studies to evaluate whether 1) drug
delivered by GUIDE-Tx is of a sufficient dose and is retained by the artery, 2) GUIDE-Tx reduces neointimal
hyperplasia, 3) systemic doses of drug following GUIDE-Tx treatment are safe and low. Key technological
innovations for this project include a dual mode intravascular drug delivery and imaging system. Plans for
Phase III include clinical trials to demonstrate the safety and efficacy of GUIDE-Tx.
这个直接进入第二阶段SBIR项目解决了在较低的药物浓度后安全有效的药物输送的需求。
肢体血管成形术全球超过2亿人患有外周动脉疾病(PAD)。两者
PAD的疾病和经济负担预计将迅速增长,美国PAD人口预计将
到2020年将增长到2200万美元,因为目前的成本超过200亿美元。这种增长的主要原因是美国的老龄化
面临患病率随年龄增长而增加的疾病的人口。在高级阶段
PAD,血管成形术,闭塞动脉的扩张,是治疗的最新技术。但
血管成形术的寿命在外周可短至3个月,这是由于再狭窄、血管的再闭塞、再狭窄和再狭窄。
由于自身细胞的过度生长而阻塞了动脉。因此,建议干预者等待,
对患者进行血管成形术,直到发生严重肢体缺血(CLI),即灾难性的血管阻塞
导致剧烈疼痛并可能导致截肢
为了满足这些需求,SoundPipe正在商业化一个平台,以提供可以预防的药物。
再狭窄,超声成像引导和增强治疗药物递送(GUIDE-Tx)
系统这种新颖的基于导管的系统使用超声来同时对脉管系统进行成像,
增强血管成形术后再狭窄预防药物的递送。药物由微泡携带
从导管的尖端喷出,在那里它们被血管内超声引导到精确的位置。
在那里,在超声图像引导下,超声和微泡增强了细胞的透化。
细胞膜并从微泡中释放药物。该技术控制药物剂量和空间
覆盖范围,提供了一种预防血管成形术后再狭窄的通用方法。SoundPipe的技术将
通过以下方式改善血管成形术:1)允许介入医生控制药物剂量、类型和覆盖范围; 2)
在药物输送期间提供图像引导。增加的多功能性将促进该领域的创新,
血管内药物输送。
本直接进入II期SBIR将使用一系列猪和兔体内研究来评估1)药物
由GUIDE-Tx递送的药物具有足够的剂量并被动脉保留,2)GUIDE-Tx减少新生内膜
3)GUIDE-Tx治疗后药物的全身剂量是安全和低的。关键技术
该项目的创新包括双模式血管内药物输送和成像系统。计划
第三阶段包括临床试验,以证明GUIDE-Tx的安全性和有效性。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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{{ truncateString('Joseph P. Kilroy', 18)}}的其他基金
Ultrasound Enhanced Low Dose Drug Delivery: Quantifying Uptake, Retention and Biodistribution
超声增强低剂量药物输送:量化摄取、保留和生物分布
- 批准号:
9409094 - 财政年份:2017
- 资助金额:
$ 38.17万 - 项目类别:
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