First-in-Human Use of an Artificial Lung for Ambulatory Respiratory Support

首次在人体中使用人工肺进行动态呼吸支持

基本信息

批准号：
9057610
负责人：
Bartley P GriffIth
金额：
$ 84.79万
依托单位：
UNIVERSITY OF MARYLAND BALTIMORE
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-07-05 至 2018-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9057610
关键词：
Acute Acute Disease Advanced Development Adverse event Animals Area Biocompatible Blood Blood flow Cannulas Chronic Chronic lung disease Clinic Clinical Destinations Detection Development Devices Diagnostic Effectiveness Electromagnetics Electronics Evaluation Exercise Extracorporeal Membrane Oxygenation FDA approved Future Gases Goals Guidelines Healed Healthcare Heart failure Hospitals Hour Human In Vitro Injury Laboratories Lung Lung diseases Measures Mechanical ventilation Mechanics Monitor Motor National Heart, Lung, and Blood Institute Operative Surgical Procedures Outcome Measure Oxygen Patients Performance Preparation Process Pump lung Qualifying Quality Control Quality of life Refractory Research Proposals Respiratory Failure Safety Software Validation Source Staging Sterilization Support System System Technology Testing Translating Translational Research Transplantation Treatment Effectiveness Ultrasonics Validation Ventricular artificial lung base bench to bedside biomaterial compatibility design exhaust experience good laboratory practice healing human study improved in vivo manufacturing process novel novel therapeutics pre-clinical public health relevance quality assurance regenerative therapy respiratory response sensor sterility testing tool treatment effect ventricular assist device verification and validation

项目摘要

DESCRIPTION (provided by applicant): Acute and chronic end stage lung disease (ESLD) are increasing healthcare problems. Currently, when mechanical ventilation fails only extracorporeal membrane oxygenation (ECMO) systems with components designed and qualified for a few hours are available. These are often associated with serious complications and generally are restricted to bedside use. Like the further evolved field of mechanical circulatory support in response to refractory heart failure, a wearable, biocompatible integrated pump-lung would offer significant advantages to patients over existing options. Such a device might would pose a prolonged ambulatory platform for natural lung healing from acute injury, a bridge to transplant or destination therapy, or for novel lung regenerative therapies. With support from the NHLBI, we have made remarkable progress in development of a novel artificial pump-lung (APL) device for ambulatory respiratory support. The technology is near ready to be translated to the clinics for human use The goal of this translational research is to complete development of the advanced prototypical pump lung (APL) for ambulatory use in a first-in-human (FIM) trial. The APL will be joined with cannulae and a portable driver consisting of electronics, battery and oxygen source as an artificial pump lung system (APLS). The APLS will undergo preclinical validation and testing per FDA guidelines to receive an Investigational Device Exemption (IDE). Four specific aims of the proposal are: (1) to complete development of the preclinical APLS, including the APL, cannulae, diagnostic sensors and a portable driver, and develop enabling technologies; (2) to develop processes and tools for manufacturing clinical grade APLS; (3) to qualify the APLS for clinical use in an FDA approved first-in-human study; and (4) to conduct a First-in-Human trial of the APLS to measure effect of treatment, basic safety and human response factors. The successful completion of these specific aims should result in a keystone respiratory support system that will, like the introduction of ventricular assst devices (VAD) for heart failure 20 years earlier, be a new therapeutic option for those with morbid, acute, and chronic pulmonary illnesses. The quality of life for the patients will be dramatically improved with the ambulatory and "out of hospital use" APLS

描述（由申请人提供）：急性和慢性终末期肺病（ESLD）正在加剧医疗保健问题。目前，当机械通气出现故障时，只能使用组件设计并经过数小时验证的体外膜肺氧合 (ECMO) 系统。这些通常与严重并发症相关，并且通常仅限于床边使用。就像针对难治性心力衰竭的机械循环支持领域的进一步发展一样，可穿戴、生物相容性集成泵肺将为患者提供优于现有选择的显着优势。这种设备可能会为急性损伤的肺部自然愈合提供一个长时间的流动平台，为移植或目标治疗或新型肺再生疗法提供桥梁。在 NHLBI 的支持下，我们在开发用于动态呼吸支持的新型人工泵肺 (APL) 装置方面取得了显着进展。该技术即将转化为临床供人类使用。这项转化研究的目标是完成先进原型泵肺 (APL) 的开发，用于首次人体 (FIM) 试验中的流动使用。 APL 将与插管和由电子设备、电池和氧气源组成的便携式驱动器连接，作为人工泵肺系统 (APLS)。 APLS 将根据 FDA 指南进行临床前验证和测试，以获得研究器械豁免 (IDE)。该提案的四个具体目标是：（1）完成临床前APLS的开发，包括APL、插管、诊断传感器和便携式驱动器，并开发使能技术； (2) 开发制造临床级APLS的流程和工具； (3) 使 APLS 在 FDA 批准的首次人体研究中获得临床使用资格； (4) 对 APLS 进行首次人体试验，以衡量治疗效果、基本安全性和人体反应因素。成功完成这些具体目标应该会产生一个关键的呼吸支持系统，就像 20 年前针对心力衰竭引入心室辅助装置 (VAD) 一样，该系统将成为病态、急性和慢性肺心病患者的新治疗选择。疾病。通过门诊和“院外使用”APLS，患者的生活质量将得到显着改善