Stem Cell Bioreactor for Cardiac Care

用于心脏护理的干细胞生物反应器

• 批准号: 9260075
• 负责人: Arno W Tilles
• 金额: $ 80万
• 依托单位: SENTIEN BIOTECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-09 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9260075
• 关键词: Acute; Acute myocardial infarction; Affect; Anti-Inflammatory Agents; Anti-inflammatory; Back; Biomedical Engineering; Bioreactors; Biotechnology; Blood; Bone Marrow; Bypass; Canis familiaris; Cardiac; Cardiac Surgery procedures; Caring; Cell Membrane Permeability; Cell Survival; Cell Therapy; Cell Transplants; Cell physiology; Cell secretion; Cells; Chronic; Clinical; Clinical Research; Congestive Heart Failure; Critical Care; Critical Illness; Cytokine Receptors; Data; Devices; Dose; Drug Delivery Systems; Effectiveness; Engineering; Evaluation; Exposure to; Family suidae; Fiber; Functional disorder; Goals; Gold; Growth Factor; Healthcare; Heart; Heart Diseases; Human; Industrialization; Inflammation; Inflammatory; Injection of therapeutic agent; Injury; Intervention; Ischemia; Kidney; Legal patent; Life; Lung; Measures; Membrane; Mesenchymal Stem Cell Transplantation; Mesenchymal Stem Cells; Metabolic; Modeling; Morbidity - disease rate; Myocardial Infarction; Neurocognitive; Obesity; Operative Surgical Procedures; Organ; Organ failure; Outcome; Patient Care; Patients; Peripheral; Permeability; Phase; Prevention therapy; Protocols documentation; Reperfusion Injury; Reperfusion Therapy; Risk; Safety; Sentinel; Shipping; Small Business Innovation Research Grant; Stem cells; System; Technology; Temperature; Testing; Therapeutic; Therapeutic Studies; Time; Tissues; Toxic effect; Translating; Whole Blood; base; biomaterial compatibility; blood perfusion; burden of illness; clinical research site; clinically relevant; combinatorial; cytokine; design; dosage; efficacy study; efficacy testing; healing; heart function; improved; in vivo; lipid mediator; mortality; novel; operation; prevent; prototype; renal ischemia; repaired; scale up

 DESCRIPTION (provided by applicant): The goal of this Fast-Track Phase I/II SBIR is to test a novel extracorporeal system for delivering mesenchymal stem cell (MSC) secretions to treat acute myocardial infarction (MI). We will use the Sentien proprietary extracorporeal delivery system to treat swine subjected to a clinically relevant model of MI. The project specific aims are: (1) Simulated blood perfusion to select most potent MSC bioreactor membrane (Ph. I); (2) Stability analysis of manufactured Sentinel devices (Ph II); and (3) Therapeutic studies of MSC bioreactors in pigs with MI (Ph. II). Our Phase I milestone is the identification of dialyzer membrane to optimize MSC potency. The Phase II deliverables of the studies include (1) protocol for shipping and storage of our devices; (2) assessment of toxicity of our devices in healthy swine; (3) the ideal timing window for efficacious treatment of acute MI in swine; and (4) efficacy data compared to MSC transplantation. With the completion of the studies described herein, our bioreactor will be poised for immediate testing in human patients.

 描述（由申请人提供）：本快速通道I/II期SBIR的目标是测试一种新型体外系统，用于输送间充质干细胞（MSC）分泌物治疗急性心肌梗死（MI）。我们将使用Sentien专有的体外输送系统治疗患有临床相关MI模型的猪。该项目的具体目标是：（1）模拟血液灌注以选择最有效的MSC生物反应器膜（Ph. I）;（2）制造的Sentinel装置的稳定性分析（Ph. II）;和（3）MSC生物反应器在患有MI的猪中的治疗研究（Ph. II）。我们的I期里程碑是确定透析器膜以优化MSC效力。研究的II期可交付成果包括（1）我们器械的运输和储存方案;（2）我们器械在健康猪中的毒性评估;（3）有效治疗猪急性MI的理想时间窗;以及（4）与MSC移植相比的疗效数据。随着本文所述研究的完成，我们的生物反应器将准备立即在人类患者中进行测试。