New infusible ECM hydrogel for treating acute myocardial infarction
New infusible ECM hydrogel for treating acute myocardial infarction
批准号:
9907247
负责人:
Karen L Christman
金额:
$79.15万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2020
资助国家:
美国
项目状态:
已结题
起止时间:
2020-05-20 至 2021-04-30
关键词:
AcuteAcute myocardial infarctionAmericanAnimalsApoptosisArrhythmiaBalloon AngioplastyBalloon OcclusionBiocompatible MaterialsCardiac MyocytesCardiomyopathiesCathetersCause of DeathCell TherapyCellsDataDevelopmentEchocardiographyEnvironmentExtracellular MatrixFamily suidaeFibrosisFormulationGelGeometryGerm CellsGuidelinesHeartHeart TransplantationHeart failureHistologyHolter ElectrocardiographyHydrogelsImmunohistochemistryInfarctionInfusion proceduresInjectableInjectionsInterventionLeftMeta-AnalysisMetabolismModelingMyocardialMyocardial InfarctionMyocardiumOrganParticulatePatientsPhasePhase I Clinical TrialsPre-Clinical ModelRattusRecording of previous eventsRecurrenceRegenerative MedicineSafetySmall Business Innovation Research GrantTestingTherapy trialTissue EngineeringTissuesTranslatingUnited States National Institutes of HealthVentricularclinically relevantcostheart functionimprovedinflammatory milieuischemic cardiomyopathyleft ventricular assist deviceminimally invasiveneovascularizationnew technologynovelnovel therapeuticsparticlepatient populationphase II trialpreclinical studyregenerativerepairedstandard of carestatisticssubmicronsuccesstherapy development
中文摘要
总结
心肌梗死(MI)后心力衰竭仍然是美国的主要死亡原因。
据估计,约55万美国人将有一个新的MI,约20万将有一个复发性MI和大多数
这些病人会患上心脏衰竭。这些令人震惊的统计数字需要开发新的
缺血性心肌病患者的治疗方法。组织工程与再生医学策略
为开发治疗这些患者的新疗法提供了巨大的潜力。最近,非细胞
生物材料在提供功能性益处而没有与
其他再生医学方法。刺激内源性修复的可注射生物材料是
因为潜在的治疗仍然可以通过导管微创地输送,
与其他再生医学产品相比,
细胞因此,Ventrix专注于无细胞再生医学方法。文特里克斯有一个历史,
成功开发可注射生物材料用于治疗缺血性心肌病。前两次NIH SBIRs
导致VentriGel获批IND,VentriGel是一种可注射的导管输送水凝胶,
脱细胞猪心肌。这导致了最近在60天至3天的患者中成功的1期临床试验
年后的MI。本文提出的研究是将新的生物材料产品推向市场的关键一步,
治疗急性心肌梗死。这种新型可溶性VentriGel可通过冠状动脉内输注输送,
能够在MI后立即进行治疗,不像原始制剂需要经内分泌递送。
在此,我们将通过优化交付和评估功能来测试翻译这项新技术的可行性
在大型动物急性MI模型中。这将是第一个冠状动脉内可输注再生生物材料产品
用于治疗急性心肌梗死患者
英文摘要
Summary
Heart failure post-myocardial infarction (MI) continues to be the leading cause of death in the U.S. Each year it
is estimated that ~550K Americans will have a new MI, and ~200K will have a recurrent MI and a majority of
these patients will suffer from heart failure. These staggering statistics necessitate the development of new
therapies for patients with ischemic cardiomyopathy. Tissue engineering and regenerative medicine strategies
offer significant potential for the development of novel therapies to treat these patients. Recently, acellular
biomaterials have shown great promise in providing functional benefit without the complications associated with
other regenerative medicine approaches. Injectable biomaterials that stimulate endogenous repair are an
attractive alternative since potential therapies could still be delivered minimally invasively via catheter yet could
be off the shelf and have significantly reduced costs compared to other regenerative medicine products, such as
cells. Ventrix is therefore focusing on cell-free regenerative medicine approaches. Ventrix has a history of
success in developing injectable biomaterials for treating ischemic cardiomyopathy. Two previous NIH SBIRs
resulted in an approved IND for VentriGel, an injectable, catheter-deliverable hydrogel derived from
decellularized porcine myocardium. This led to a recent successful Phase 1 clinical trial in patients 60 days to 3
years post-MI. The study proposed herein is a key step in bringing a new biomaterial product to market for
treating acute MI. This new soluble version of VentriGel can be delivered via intracoronary infusion, which will
enable treatment immediately post-MI, unlike the original formulation, which required transendocardial delivery.
Herein, we will test the feasibility of translating this new technology by optimizing delivery and evaluating function
in a large animal acute MI model. This will be the first intracoronary infusible regenerative biomaterial product
for treating acute MI patients.
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会议论文
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依托单位:
Autonomously Assembling Nanomaterial Scaffolds for Treating Myocardial Infarction
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海外基金