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

• 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
• 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

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）是日益严重的医疗保健问题。目前，当机械通气失败时，只有体外膜式氧合（ECMO）系统的组件设计和鉴定为几个小时可用。这些通常与严重并发症有关，通常仅限于床边使用。与应对难治性心力衰竭的机械循环支持的进一步发展领域一样，可穿戴的生物相容性集成泵肺将为患者提供优于现有选择的显著优势。这样的设备可能会构成一个长期的流动平台，用于急性损伤的自然肺愈合，移植或目的地治疗的桥梁，或用于新的肺再生治疗。在NHLBI的支持下，我们在开发一种新型的用于非卧床呼吸支持的人工泵肺（APL）设备方面取得了显著进展。该技术即将转化为临床应用。这项转化研究的目标是完成先进的原型泵肺（APL）的开发，用于首次人体试验中的非卧床使用。APL将与插管和便携式驱动器（由电子设备、电池和氧气源组成）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，以获得试验用器械豁免（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、套管、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的工艺和工具;（3）使APLS有资格在FDA批准的首次人体研究中临床使用;及（4）进行首次人体试验，以量度治疗效果、基本安全性及人体反应因素。这些特定目标的成功完成将导致一个关键的呼吸支持系统，就像20年前引入心室辅助装置（VAD）治疗心力衰竭一样，它将成为那些患有病态，急性和慢性肺部疾病的人的新治疗选择。病人的生活质量将大大改善与门诊和“院外使用”APLS