Advanced Platform Technology Center of Excellence

先进平台技术卓越中心

• 批准号: 8891069
• 负责人: Gilles Pinault
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-01-01 至 2019-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8891069
• 关键词: Adverse event; Amputees; Animals; Area; Award; Basic Science; Biohazardous Substance; Biomimetic Materials; Bladder; Braces-Orthopedic appliances; Budgets; Businesses; Caring; Child; Chronic; Clinic; Clinical; Clinical Investigator; Clinical Trials; Cognitive deficits; Collaborations; Communication; Community Healthcare; Contracts; Creativeness; Development; Devices; Diagnosis; Disabled Persons; Discipline; Disclosure; Documentation; Effectiveness; Electric Stimulation Therapy; Electrodes; Engineering; Ensure; Environment; Esthesia; Evaluation; Event; Extramural Activities; FPS-FES Oncogene; Funding; Grant; Health; Healthcare; Home environment; Human; Human Resources; Implant; Incontinence; Individual; Industry; Information Technology; Institutes; Institution; Intellectual Property; Intervention; Investments; Leadership; Legal patent; Licensing; Limb Prosthesis; Limb structure; Locomotion; Maintenance; Manufacturer Name; Mechanics; Medical; Medical Technology; Medical center; Mentors; Methods; Microfabrication; Minor; Minority; Mission; Modeling; Monitor; Motor; Nerve; Nervous system structure; One-Step dentin bonding system; Orthotic Devices; Paralysed; Peripheral; Population; Postdoctoral Fellow; Process; Production; Prosthesis; Publications; Quality Control; Rattus; Recruitment Activity; Regulatory Affairs; Rehabilitation therapy; Research; Research Infrastructure; Research Personnel; Research Project Grants; Research Support; Resources; Rest; Rewards; Science; Scientist; Secure; Seeds; Sensory; Services; Shunt Device; Solutions; Source; Specialist; Surface; System; Techniques; Technology; Technology Transfer; Testing; Therapeutic; Time; Training; Transcend; Translating; Translational Research; Translations; United States National Institutes of Health; Universities; Upper Extremity; Ventricular; Vertebrates; Veterans; Visit; Wearable Computer; Wireless Technology; Woman; Work; Wound Healing; afferent nerve; artificial lung; base; biomaterial compatibility; brain computer interface; career; clinical application; clinical practice; collaborative environment; cost; cost effectiveness; daily functioning; density; design; disability; engineering design; experience; human capital; human subject protection; implantation; implanted sensor; in vivo; innovation; man; microsystems; mild traumatic brain injury; motor deficit; nanocomposite; neural prosthesis; neuroprosthesis; new technology; novel; operation; orthotics; outreach; pre-clinical; preclinical study; pressure; programs; prosthetic socket; prototype; pulmonary function; quality assurance; relating to nervous system; research and development; research clinical testing; sensor; success; wound

 Description: Provide a brief description of the center and its focus. This is a CoE renewal application for the third grant period of the "Advanced Platform Technology Center of Excellence" from the Louis Stokes Cleveland VA Medical Center. The PI is Ron Triolo, a very experienced and well-funded investigator with awards from NIH (2), VA RR&D (2) and DOD (2) in addition to the current version of the Center. The proposed CoE is an infrastructure for translation and translational research in four main areas: Prosthetics/Orthotics Health Monitoring/Maintenance, Neural Interfacing and emerging Enabling Technologies. The CoE will predominantly fund the staff and some investigators, with support for research mainly occurring through leveraging grant and a modest pilot program. In each of these areas the CoE will work to move individual projects through the translational spectrum from basic science to proof of concept in animals to in vivo testing to in humans to clinical trials. As a result progres is made toward problems of great importance to the RR&D mission. There is great synergy in the local environment with the FES CoE, Case Western Reserve University and the Cleveland Clinic. The CoE investigators are leaders in the different research areas with more than $7 million in active funding for the current year. There is particular strength in prosthetics and neural interfacing. If funded, it is expected that a number of projects and technologies would be translated (or moved one step further along the translational continuum). The projects presented (the majority already funded by current active funding) are clearly feasible and well thought out. The previous funding cycle was exceptionally successful with CoE investigators receiving more the $58 million in external funding and the center becoming home to two PECASE awardees, six CDA recipients and two Senior Research Career Scientists as well as other senior investigators responsible for almost 250 publications, more than 330 presentations, 105 outreach and media events, and over 100 disclosures, 75 patent applications and licenses. Evaluation: Significance and Impact of Prior Work: The CoE has been incredibly productive (metrics given above) and has established a great working model, which has led to a number of promising translational research advances such as: * Determining the biocompatibility of novel nanocomposite material in rat cortex and developing new microfabrication techniques to process it into functional cortical recording probes, thus moving the project from proof-of-concept to initial pre-clinical testing. * Refining prototypes of wireless implanted bladder pressure monitor and modular surface electrotherapy system to test in vertebrate animals to prepare them for transition to first-in-man clinical feasibility trials * Filed a Device Master File for the FINE (flat interface nerve electrode), which was accepted by the FDA and referenced in two successful IDEs, enabling chronic human implantation for natural sensation to upper limb amputees and facilitate standing and stepping after paralysis. The devices have now been functioning without adverse event in amputees for more than two years. There are numerous additional examples of high impact research at various levels along the translational research continuum. Strength of Proposed Research Focus: The proposed work is highly relevant to the veteran population and it is certain that it will produce much new and useful information. The research focus areas have been defined very clearly and the high priority projects in each are detailed in such a manner that it seems very clear that the CoE will be able to execute the research projects successfully. There is much that will be contributed to the VA RR&D portfolio. One potential weakness is that several of the projects will contribute more to veteran health care than to rehabilitation practice as they are more general medical solutions. That being said, they are high impact projects that are able to use the developed infrastructure so this is at most a minor concern. Effectiveness of Operating Plan: This is a great strength of the proposal. The infrastructure that they are using has been proven to work. CoE funds support an outstanding professional support staff. They fund all or part of the following: regulatory affairs specialist, quality assurance specialist, engineering manager, director of external affairs and industrial relations, director of internal operations, information technology specialist, and various engineering staff (several supported entirely by research grants at the current time). Thus, most of the budget goes to professional staff to facilitate the success of the individual investigators to obtain extramural funding, which funds the research of the CoE. They will have a substantial impact with the overall VA research program as they are designed to be a national resource and collaborate with a number of different VA's beyond their local medical center and nearby CoE. They make their platform available to investigators nationwide. They also have developed a number of relationships with commercial businesses which will greatly facilitate the translation of their research to the VA and the rest of the healthcare community. Adequacy of Resources: The current VA RR&D program is exceptional. There are a large number of funded investigators with active VA and non-VA research funding (leveraged the CoE funding to $56 million to investigators over the last grant cycle). In addition there is strong support from the VA clinical investigators, VA administration and the academic affiliates. The scientific, engineering, or medical leadership of key personnel at the VA are outstanding. As noted previously, Dr. Triolo has an exceptional track record and record of current funding. Other investigators leading the various focus areas are also outstanding. The combination of VA resources and academic affiliate resources made available are also outstanding. Budget and Cost Effectiveness: The budget is able to support the program activities due to investigators being funded through VA Research Career Scientist awards or external research grant funding. The requested costs are reasonable. Additional Items: a. Protection of Human Subjects b. Inclusion of Women, Minorities, and Children c. Vertebrate Animals d. Biohazards All are acceptable. Summary Bullets: * Outstanding track record in previous grant periods and environment * Stellar PI and investigative team * Importance of proposed research areas to VA research program

 描述：简要描述该中心及其重点。 这是路易斯·斯托克斯克利夫兰退伍军人医疗中心“高级平台技术卓越中心”第三个资助期的 CoE 续签申请。 PI 是 Ron Triolo，他是一位经验丰富、资金雄厚的研究人员，除了当前版本的中心外，还获得过 NIH (2)、VA RR&D (2) 和 DOD (2) 的奖项。拟议的 CoE 是四个主要领域的转化和转化研究的基础设施：假肢/矫形器健康监测/维护、神经接口和新兴使能技术。 CoE 将主要为工作人员和一些研究人员提供资金，并主要通过利用赠款和适度的试点计划来支持研究。在每个领域，CoE 将致力于推动各个项目的转化，从基础科学到动物概念验证，再到体内测试，再到人体临床试验。结果，在对研发任务非常重要的问题上取得了进展。与 FES CoE、凯斯西储大学和克利夫兰诊所在当地环境中具有巨大的协同作用。 CoE 的研究人员是不同研究领域的领导者，今年的积极资助超过 700 万美元。在假肢和神经接口方面具有特殊优势。如果获得资助，预计许多项目和技术将被转化（或沿着转化连续体更进一步）。所提出的项目（大部分已经由当前的积极资金资助）显然是可行的并且经过深思熟虑。上一个资助周期非常成功，CoE 调查人员获得了超过 5800 万美元的外部资金，该中心成为两名 PECASE 获奖者、六名 CDA 获得者和两名高级研究职业科学家以及其他高级调查人员的所在地，负责近 250 份出版物、超过 330 场演示、105 次外展和媒体活动、超过 100 项披露、75 项专利申请和许可。 评估： 先前工作的意义和影响： CoE 的生产力令人难以置信（上面给出的指标），并建立了一个出色的工作模型，这带来了许多有希望的转化研究进展，例如： * 确定新型纳米复合材料在大鼠皮质中的生物相容性，并开发新的微加工技术，将其加工成功能性皮质记录探针，从而使该项目从概念验证转向初始临床前测试。 * 完善无线植入式膀胱压力监测器和模块化表面电疗系统的原型，以在脊椎动物中进行测试，为它们过渡到首次人体临床可行性试验做好准备 * 提交了 FINE（平面接口神经电极）的设备主文件，该文件已被 FDA 接受并在两个成功的 IDE 中引用，使上肢截肢者能够长期植入人体以获得自然感觉，并有助于瘫痪后站立和行走。这些装置现已运行两年多，没有给截肢者带来任何不良事件。 在转化研究的连续体中，还有许多其他不同层次的高影响力研究的例子。 拟议研究重点的优势： 拟议的工作与退伍军人群体高度相关，并且肯定会产生许多新的有用信息。研究重点领域的定义非常明确，每个领域的高优先级项目都以这样的方式进行了详细说明，看起来非常清楚 CoE 将能够成功执行这些研究项目。 VA RR&D 投资组合将做出很多贡献。一个潜在的弱点是，其中一些项目对退伍军人医疗保健的贡献大于对康复实践的贡献，因为它们是更通用的医疗解决方案。话虽如此，它们是能够利用发达基础设施的高影响力项目，因此这最多只是一个小问题。 运营计划的有效性： 这是该提案的一大优势。他们使用的基础设施已被证明有效。 CoE 资金支持优秀的专业支持人员。他们资助以下全部或部分工作：监管事务专家、质量保证专家、工程经理、外部事务和劳资关系总监、内部运营总监、信息总监 技术专家和各种工程人员（其中一些人目前完全由研究经费支持）。因此，大部分预算都流向专业人员，以促进个别研究人员成功获得外部资金，为 CoE 的研究提供资金。他们将对整个 VA 研究计划产生重大影响，因为它们被设计为国家资源，并与当地医疗中心和附近 CoE 之外的许多不同的 VA 合作。他们向全国调查人员提供平台。他们还与商业企业建立了许多关系，这将极大地促进他们的研究成果向退伍军人管理局和其他医疗保健界的转化。 资源充足性： 当前的 VA RR&D 计划非常出色。有大量受资助的研究人员拥有积极的 VA 和非 VA 研究经费（在上一个资助周期中，利用 CoE 资金为研究人员提供了 5600 万美元）。此外，还有 VA 临床研究人员、VA 管理部门和学术机构的大力支持。 VA 关键人员的科学、工程或医学领导能力非常出色。如前所述，Triolo 博士拥有出色的业绩记录和当前资助记录。领导各个重点领域的其他研究人员也很出色。 VA 资源和学术附属资源的结合也非常出色。 预算和成本效益： 由于研究人员通过 VA 研究职业科学家奖或外部研究补助金资助，因此预算能够支持计划活动。所要求的费用是合理的。 附加项目： 一个。 保护人类受试者 b. 妇女、少数民族和儿童的包容 c. 脊椎动物 d. 生物危害 一切都可以接受。 摘要要点： * 在之前的资助期间和环境中拥有出色的业绩记录 * 一流的 PI 和调查团队 * 拟议研究领域对 VA 研究计划的重要性