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Production Assistance for Cellular Therapies (PACT)- Cell Processing Facilities Cell manufacturing and process development services for PCT0031-02: GMP Production of iPSC Line and Scale-up of Cardiac

Production Assistance for Cellular Therapies (PACT)- Cell Processing Facilities Cell manufacturing and process development services for PCT0031-02: GMP Production of iPSC Line and Scale-up of Cardiac
细胞疗法生产协助 (PACT) - 细胞加工设施 PCT0031-02 的细胞制造和工艺开发服务：iPSC 生产线的 GMP 生产和心脏的放大
批准号：
10090766
负责人：
Joshua M Hare
金额：
$101.72万
依托单位：
UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
项目状态：
已结题
起止时间：
2019-12-10 至 2021-08-09
来源：
https://reporter.nih.gov/project-details/10090766
关键词：
CardiacCardiac developmentCell Differentiation processCell LineCell TherapyCellsClinicalFibroblastsHaresHumanNational Heart, Lung, and Blood InstitutePeer ReviewProductionProtocols documentationResourcesServicesUnited States National Institutes of Healthcell bankexosomeinduced pluripotent stem cellmanufacturing process developmentprogramsscale upstem cells

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中文摘要
翻译
这项任务的目的是向经批准的PACT计划申请者提供电池制造服务。Hare博士的CPF将向请求者Ashraf博士提供临床级心脏祖细胞和外切体。该项目已经通过了外部同行审查委员会的科学价值审查和NHLBI公约项目/计划官员的行政审查。
英文摘要
The purpose of this task order to provide cell manufacturing services to an approved PACT program requestor. Dr. Hare's CPF will provide clinical grade Cardiac progenitor cells and exosomes to the requestor, Dr. Ashraf. The project has undergone scientific merit review by an external, peer review board and administrative review by NHLBI PACT project/program officers.
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会议论文
Full-scale GMP Production for a Pre-Clinical Systemic Delivered Mesenchymal Stem Cells Derived Extracellular Vesicles For Cardiovascular Disease
1/2 Allogeneic Human Mesenchymal Stem Cell (MSC) Injection in Patients with Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial
1/2 Allogeneic Human Mesenchymal Stem Cell (MSC) Injection in Patients with Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial
A Phase 2b Clinical Trial to Study the Efficacy of Longeveron Mesenchymal Stem Cells (LMSCs) to Treat Aging Frailty
  • 批准号：
    9922198
  • 项目类别：
  • 资助金额：
    $197.43万
  • 财政年份：
    2018
  • 负责人：
    Joshua M Hare
  • 依托单位：
    LONGEVERON, LLC
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