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：
8483968
负责人：
Bartley P GriffIth
金额：
$ 99.45万
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/8483968
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 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）：急性和慢性末期肺病（ESLD）正在增加医疗保健问题。目前，当机械通气失败时，只有具有组件的体外膜氧合（ECMO）系统设计和合格了几个小时。这些通常与严重的并发症有关，通常仅限于床边使用。就像响应难治性心力衰竭的机械循环支持的进一步进化的领域一样，可穿戴的，可穿戴的，可生物相容性的集成泵肺将为患者提供显着优势。这样的装置可能会造成长时间的门诊平台，以通过急性损伤，移植或目的地治疗的桥梁或新型的肺再生治疗中的天然肺愈合。在NHLBI的支持下，我们在开发一种新型的人造泵肺（APL）设备方面取得了显着的进展，用于卧床呼吸支持。该技术已经准备好将其转化为人类使用的诊所，这项翻译研究的目的是完整开发先进的原型泵肺（APL），以便在首次人类（FIM）试验中进行门诊。 APL将与套管和由电子，电池和氧气源组成的便携式驱动器连接，作为人造泵肺系统（APLS）。 APL将根据FDA指南进行临床前验证和测试，以获得研究设备豁免（IDE）。该提案的四个具体目的是：（1）完成临床前APL的开发，包括APL，套管，诊断传感器和便携式驱动器，并开发启用技术；（2）开发制造临床级APL的工艺和工具；（3）在FDA批准的人类研究中，有资格的APL用于临床使用；（4）对APL进行的第一个人类试验，以衡量治疗，基本安全和人类反应因素的影响。这些特定目标的成功完成应导致一个基石呼吸支持系统，该系统将像20年前引入心力衰竭的心脏衰竭一样，对于患有病态，急性和慢性肺部疾病的人来说，这是一种新的治疗选择。随着门诊和“不在医院使用” APLS，患者的生活质量将大大改善