Prevention and Early Treatment of Acute Lung Injury

急性肺损伤的预防和早期治疗

基本信息

批准号：
8705240
负责人：
MICHAEL A. MATTHAY
金额：
$ 14.8万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-06-17 至 2021-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8705240
关键词：
Academic Medical Centers Accident and Emergency department Acute Acute Lung Injury Adult Respiratory Distress Syndrome Allogenic Anesthesia procedures Area Basic Science Bilateral Biological Biological Markers Bone Marrow California Chest Clinical Clinical Protocols Clinical Research Clinical Trials Clinical Trials Design Clinical Trials Network Collaborations Commit Communication Communities Critical Care Critical Illness DNA Data Development Early treatment Emergency Medicine Enrollment Environmental air flow Funding Hospitals Human Institution Institutional Review Boards Intensive Care Units Intravenous Location Lung Maps Medical center Medicine Mesenchymal Stem Cells Methods Mucositis National Heart, Lung, and Blood Institute Oxygen Participant Patient Care Patient Recruitments Patients Persons Phase Phase III Clinical Trials Population Prevention Principal Investigator Proteins Protocols documentation Recombinants Research Research Personnel Risk Safety Sampling San Francisco Site Specimen Subgroup Syndrome System Teaching Hospitals Teleconferences Telephone Testing Therapeutic Therapeutic Agents Universities University Hospitals Work base design experience keratinocyte growth factor lung injury meetings mortality novel novel therapeutics pre-clinical pressure professor prognostic public health relevance respiratory screening symposium

项目摘要

DESCRIPTION (provided by applicant): This proposal from the University of California, San Francisco (UCSF) responds to RFA HL-14-014 for Clinical Centers for the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network, with a commitment to enroll 40 patients annually in clinical trials based in the Emergency Departments and the Intensive Care Units. The Principal Investigator will be Michael A. Matthay, MD, Professor of Medicine & Anesthesia at UCSF and the Co-Investigator will be Greg Hendey, MD, Professor and Chair, Emergency Medicine, UCSF-Fresno. There will be four participating hospitals that have an established track record of effective communication, collaboration and patient recruitment as part of the Acute Respiratory Distress Syndrome (ARDS) Network 2: (1) UCSF Moffitt-Long Hospital, the major teaching hospital at UCSF; (2) UCSF Fresno/Community Regional Medical Center, a major medical center caring for patients in the Central Valley of California located in Fresno, CA; (3) University of California, Davis Medical Center; and (4) Stanford University Medical Center. Thus, the California Network will be comprised of four major medical centers in Northern California that draw from a total population of approximately 12 million people. Each site has an established and highly motivated research coordinator and critical care investigator with experience in ARDS Network 2. To be responsive to this RFA, each site has added an Emergency Department investigator with significant prior experience in clinical trials. In addition to our work as part of ARDS Network 2 and with Emergency Department-based clinical trials, the California Network has significant expertise that is highly relevant to the current RFA. We have a major research focus on clinical criteria to identify patients at risk for ARDS prior to the initiation of positive pressure ventilation as well as a longstanding preclinical and clinical focu on novel therapeutics for ARDS. In fact, Dr. Matthay is the Principal Investigator for an ongoing NHLBI-funded phase 1/2a clinical trial of allogeneic, bone marrow-derived human mesenchymal stem cells for patients with moderate to severe ARDS that will be completed prior to the start of the PETAL Network. We are proposing two clinical protocols, one for patients with early lung injury prior to the development of ARDS that can be identified in the Emergency Department and one for patients in the Intensive Care Unit for severe ARDS. The first protocol is a phase 3 trial to test the therapeutic value of intravenous recombinant human keratinocyte growth factor in patients with early lung injury before they have met criteria for ARDS. These patients will be primarily identified in the Emergency Departments when they have bilateral pulmonary infiltrates on the chest radiograph and the need for more than 2 liters of supplemental oxygen, but do not yet require positive pressure ventilation. The second protocol is a phase 2b trial to test the potential therapeutic value of allogeneic, bone marrow-derived human mesenchymal stem cells for the treatment of patients with moderate to severe ARDS (PaO2/FiO2 < 200 mm Hg) in the Intensive Care Unit.

描述（由申请人提供）：加州大学旧金山分校 (UCSF) 的这项提案是对急性肺损伤预防和早期治疗临床中心 (PETAL) 网络 RFA HL-14-014 的回应，并承诺每年招募 40 名患者参加急诊科和重症监护室的临床试验。首席研究员将是加州大学旧金山分校医学与麻醉学教授 Michael A. Matthay 医学博士，联合研究员将是加州大学旧金山分校弗雷斯诺分校急诊医学教授兼主席 Greg Hendey 医学博士。作为急性呼吸窘迫综合征 (ARDS) 网络 2 的一部分，将有四家在有效沟通、协作和患者招募方面拥有良好记录的参与医院： (1) 加州大学旧金山分校莫菲特朗医院，加州大学旧金山分校的主要教学医院； (2) 加州大学旧金山分校弗雷斯诺/社区区域医疗中心，位于加利福尼亚州弗雷斯诺的加州中央山谷的一个主要医疗中心，为患者提供护理； (3) 加州大学戴维斯分校医学中心； (4) 斯坦福大学医学中心。因此，加州网络将由北加州的四个主要医疗中心组成，总人口约为 1200 万。每个站点都有一位既定且积极主动的研究协调员和具有 ARDS Network 2 经验的重症监护调查员。为了响应此 RFA，每个站点都增加了一名在临床试验中具有丰富经验的急诊科调查员。此外作为 ARDS Network 2 的一部分，以及基于急诊科的临床试验，加州网络拥有与当前 RFA 高度相关的重要专业知识。我们的主要研究重点是临床标准，以在治疗前识别有 ARDS 风险的患者正压通气的启动以及长期临床前和临床重点关注 ARDS 的新疗法。事实上，Matthay 博士是 NHLBI 资助的一项正在进行的 1/2a 期临床试验的首席研究员，该试验针对中度至重度 ARDS 患者使用同种异体骨髓来源的人类间充质干细胞，该试验将在试验开始前完成。花瓣网络。我们提出两种临床方案，一种适用于在急诊室发现的急性呼吸窘迫综合征（ARDS）之前出现早期肺损伤的患者，另一种适用于重症监护病房中严重急性呼吸窘迫综合征（ARDS）的患者。第一个方案是一项 3 期试验，旨在测试静脉注射重组人角质形成细胞生长因子对符合 ARDS 标准之前的早期肺损伤患者的治疗价值。当这些患者的胸片显示双侧肺部浸润并且需要超过 2 升的补充氧气，但尚不需要正压通气时，急诊科将首先识别出这些患者。第二个方案是一项 2b 期试验，旨在测试同种异体、骨髓来源的人间充质干细胞治疗重症监护病房中度至重度 ARDS（PaO2/FiO2 < 200 mm Hg）患者的潜在治疗价值。