Stem Cell Bioreactor for Cardiac Care

用于心脏护理的干细胞生物反应器

基本信息

批准号：
8948824
负责人：
Arno W Tilles
金额：
$ 24.07万
依托单位：
SENTIEN BIOTECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-07-09 至 2016-01-08
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8948824
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 Survival Cell Therapy 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 Healed Healthcare Heart Heart Diseases Human Inflammation Inflammatory Injection of therapeutic agent Injury Ischemia Kidney Legal patent Life Lung Marketing 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 Patients Perfusion Peripheral Permeability Phase Prevention therapy Protocols documentation Reperfusion Injury Reperfusion Therapy Risk Safety Sentinel Shipping Ships Small Business Innovation Research Grant Stem Cell Factor Stem cell transplant 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 testing healing heart function improved in vivo lipid mediator meetings mortality novel operation prevent prototype renal ischemia repaired scale up stem cell therapy

项目摘要

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（由适用提供）：此快速轨道I/II SBIR的目的是测试一种新型的体外系统，用于提供间充质干细胞（MSC）分泌以治疗急性心肌梗死（MI）。我们将使用Sentien专有的体外递送系统来治疗受临床相关模型MI的猪。该项目的特定目的是：（1）模拟血液灌注以选择大多数潜在的MSC生物反应膜（Ph。i）；（2）制成的前哨设备的稳定性分析（PH II）；（3）在具有MI的猪中MSC生物反应器的治疗研究（Ph。II）。我们的I阶段里程碑是鉴定透析膜以优化MSC效力。研究的第二阶段可交付成果包括（1）我们设备运输和存储的协议；（2）评估健康猪设备的毒性；（3）有效治疗猪急性MI的理想计时窗口；（4）与MSC移植相比的有效数据。随着本文所述的研究的完成，我们的生物反应器将被中毒以在人类患者中立即进行测试。