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Development and Testing of LUCID: A Therapeutic Device for Brain Injury Following Infant Cardiac Arrest

LUCID 的开发和测试：婴儿心脏骤停后脑损伤的治疗装置

基本信息

批准号：
10515831
负责人：
MAIK HUETTEMANN
金额：
$ 99.93万
依托单位：
MITOVATION, INC.
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-21 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10515831
关键词：
1 year old Achievement Address American Heart Association Animal Model Blood Circulation Blood flow Brain Brain Injuries Brain Ischemia Cardiac Surgery procedures Cardiopulmonary Resuscitation Cessation of life Child Childhood Clinical Clinical Engineering Clinical Trials Computer software Coupled Custom Data Development Device or Instrument Development Devices Dose Electroencephalography Enrollment Enzymes Foundations Free Radicals Generations Goals Grant Guidelines Head circumference Health Heart Arrest Hospitals Impairment Infant Institutional Review Boards Interruption Intervention Investigation Ischemia Ischemic Brain Injury Laboratories Legal patent Light Measures Mediating Medical Device Medical emergency Methods Mitochondria Molecular Nervous System Physiology Nervous System Trauma Neurocognitive Deficit Neurologic Neurologic Examination Neurological outcome Oxidases Oxygen Patients Phase Phototherapy Pre-Clinical Model Preparation Production Reactive Oxygen Species Reperfusion Injury Reperfusion Therapy Research Resources Respiration Resuscitation Rodent Model Safety Scalp structure Small Business Technology Transfer Research Source System Technology Temperature Testing Therapeutic Therapeutic Uses Time Tissues Translating Validation base biomaterial compatibility clinical efficacy clinical translation cost cytochrome C oxidase subunit II cytochrome c oxidase design disability first-in-human improved infant brain injury innovation multidisciplinary natural hypothermia neurocognitive test neuroprotection novel out-of-hospital cardiac arrest patient population porcine model portability pre-clinical prototype research clinical testing restoration standard care success verification and validation waveguide wound

项目摘要

Cardiac arrest in infants is a medical emergency requiring rapid resuscitation to restore circulation. However, resuscitation often results in significant brain injury, caused by ischemia/reperfusion injury. Only 36% of infants (<1yr old) treated for out-of-hospital cardiac arrest and 69% of infants that suffer in-hospital cardiac arrest are successfully resuscitated. These infants currently have no therapeutic options to limit brain injury. The current standard treatment for post-cardiac arrest brain injury is therapeutic hypothermia. Unfortunately, recent studies demonstrated that use of therapeutic hypothermia in pediatric cardiac arrest patients does not provide significant benefit beyond what is achieved with controlled normothermia. A safe and effective neuroprotective intervention that specifically targets reperfusion injury would fill a critical unmet need in the treatment of these vulnerable patients. Our molecular studies on mitochondria uncovered a novel method to non-invasively modulate mitochondrial function during reperfusion and reduce brain injury following resuscitation from cardiac arrest. Indeed, our studies have, for the first time: (i) identified two wavelengths of near infrared light (NIR) that specifically and reversibly reduce mitochondrial respiration by acting on cytochrome c oxidase (COX); (ii) documented that NIR, applied at the time of reoxygenation, is neuroprotective in rodent and swine models of infant and pediatric cardiac arrest/resuscitation; and (iii) developed a NIR-delivery system capable of providing therapeutic doses to patients up to 1 year old. Based on these data, we propose to produce the clinical Light Utilizing COX- Inhibitory Device (LUCID), a medical device that will safely deliver therapeutic NIR to the infant brain. To achieve this goal, Phase I will focus on device development and validation of LUCID in 3 experimental aims: • Develop LUCID engineered for clinical use (Aim 1). • Evaluate safety and efficacy of LUCID (Aim 2). • LUCID clinical trial development and HUD and IDE approval (Aim 3). Phase II will utilize the LUCID clinical device and execute the “LUCID Therapy for Infant Cardiac Arrest” (LUTICA) clinical trial (Aim 4). This proposal combines multi-disciplinary expertise, compelling preliminary data, and state-of-the-art resources available to our team to address a significant health problem in a highly vulnerable patient population.

婴儿心脏骤停是一种医学紧急情况，需要快速复苏以恢复血液循环。然而,