HLS-Cardiac Safety AI Trained Human Heart and Micro Heart Model

HLS-心脏安全 AI 训练的人类心脏和微心脏模型

基本信息

  • 批准号:
    9764845
  • 负责人:
  • 金额:
    $ 88.17万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2019
  • 资助国家:
    美国
  • 起止时间:
    2019-06-15 至 2021-05-31
  • 项目状态:
    已结题

项目摘要

HLS17-12. The US FDA is considering to establish a new cardiac safety assessment approach defined by a new paradigm called, “Comprehensive in vitro Proarrhythmia Assay (CIPA)”. The CIPA will 1) assess drug effects on each cardiac ion channel type individually using a high- throughput assay ion channel assays, 2) compute net effect on repolarization and risks for torsade pointes (TdP) using a mathematical model, and 3) confirm the computational prediction by measuring the drug’s effects on action potentials in induced pluripotent stem cell (iPSC) derived human cardiac myocytes (CMs). This paradigm shift, if successful, could reduce the cost of cardiac safety analyses by replacing or lowering the requirement to perform an expensive ($2-4 million) thorough QT study during clinical trials. Protecting consumers from drug induced arrhythmia and sudden deaths is a paramount importance for the regulators and pharmaceutical companies as well as lowing the cost of drug development. Many cardiac safety scientists, however, are skeptical about CIPA’s approach since CMs derived from human iPSCs exhibit a poor excitation-contraction coupling due to their immaturity. In addition, a proposed CIPA mathematical model was developed to simulate electrophysiology of human adult CMs, so there is a mismatch between experimental system and computational tool. To address these concerns, we proposed three specific aims in tw0 phases by following Fast- Track SBIR processes. Phase I feasibility Aim 1 will measure drug-induced changes in AP and CaT using human adult heart slices isolated from human donors. Here we will confirm our successful handling and analyzing human adult heart slices, which will be based on a recently published protocol by our collaborator, Dr. Igor Efimov, at George Washington University. After this validation, we will move on to perform the following two studies: Aim 2. Compare drug-induced changes in AP and CaT in NuHearts generated from adult CMs and cardiac fibroblasts from same human donor hearts; Aim 3. Validate and improve the computational models and train an artificial intelligence to predict cardiac safety risks of unknow compounds. After our successful completion proposed projects, we can establish an unprecedented cardiac safety assessment platform that can predict safety issues using a well-trained AI without doing any experiments using human heart slices that are rarely accessible for most of the safety laboratories or biotech firms.
HLS17-12。美国FDA正在考虑建立一种新的心脏安全性评估方法

项目成果

期刊论文数量(0)
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Tetsuro Wakatsuki其他文献

Tetsuro Wakatsuki的其他文献

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{{ truncateString('Tetsuro Wakatsuki', 18)}}的其他基金

Diagnostic Tools for Targeted Heart Failure Treatments
心力衰竭靶向治疗的诊断工具
  • 批准号:
    10546035
  • 财政年份:
    2022
  • 资助金额:
    $ 88.17万
  • 项目类别:
An Aging Heart Model for Drug Discovery
用于药物发现的衰老心脏模型
  • 批准号:
    9331414
  • 财政年份:
    2016
  • 资助金额:
    $ 88.17万
  • 项目类别:
Engineered Tissue Based Phenotypic Screening of Mixture based Libraries
基于工程组织的混合物库表型筛选
  • 批准号:
    9145632
  • 财政年份:
    2015
  • 资助金额:
    $ 88.17万
  • 项目类别:
Engineered Tissue Based Phenotypic Screening of Mixture based Libraries
基于工程组织的混合物库表型筛选
  • 批准号:
    9221892
  • 财政年份:
    2015
  • 资助金额:
    $ 88.17万
  • 项目类别:
Engineered Tissue Based Phenotypic Screening of Mixture based Libraries
基于工程组织的混合物库表型筛选
  • 批准号:
    9047064
  • 财政年份:
    2015
  • 资助金额:
    $ 88.17万
  • 项目类别:
MASS PRODUCTION OF PERSONALIZED HUMAN ENGINEERED HEART TISSUES
大规模生产个性化人体工程心脏组织
  • 批准号:
    8927657
  • 财政年份:
    2014
  • 资助金额:
    $ 88.17万
  • 项目类别:
MASS PRODUCTION OF PERSONALIZED HUMAN ENGINEERED HEART TISSUES
大规模生产个性化人体工程心脏组织
  • 批准号:
    8780580
  • 财政年份:
    2014
  • 资助金额:
    $ 88.17万
  • 项目类别:
Engineered tissue-based, high-throughput compound profiling
基于组织的工程化高通量化合物分析
  • 批准号:
    8252293
  • 财政年份:
    2009
  • 资助金额:
    $ 88.17万
  • 项目类别:
Engineered tissue-based, high-throughput compound profiling
基于组织的工程化高通量化合物分析
  • 批准号:
    8619035
  • 财政年份:
    2009
  • 资助金额:
    $ 88.17万
  • 项目类别:
Engineered tissue-based, high-throughput compound profiling
基于组织的工程化高通量化合物分析
  • 批准号:
    8545867
  • 财政年份:
    2009
  • 资助金额:
    $ 88.17万
  • 项目类别:

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