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：
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
项目类别：
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

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（由申请人提供）：该快速通道 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) 分泌物以治疗急性心肌梗死 (MI)。我们将使用 Sentien 专有技术。用于治疗患有临床相关心肌梗死模型的猪的体外输送系统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（第一阶段）；（2）制造的 Sentinel 装置的稳定性分析（第二阶段）；（3）心肌梗死猪的 MSC 生物反应器的治疗研究（第二阶段）我们的第一阶段里程碑是透析膜的鉴定。优化 MSC 功效的第二阶段研究成果包括 (1) 我们的设备的运输和储存方案；(2) 我们的设备在健康猪中的毒性评估；(3) 理想的时间窗口。猪急性心肌梗死的有效治疗；（4）与间充质干细胞移植相比的功效数据随着本文所述的研究的完成，我们的生物反应器将准备立即在人类患者中进行测试。