Stem Cell Bioreactor for Cardiac Care

 描述(由申请人提供)：这项快速通道I/II期SBIR的目标是测试一种新的体外系统，用于输送间充质干细胞(MSC)分泌物来治疗急性心肌梗死(MI)。我们将使用Sentien专有的体外释放系统来治疗临床相关的MI模型猪。该项目的具体目标是：(1)模拟血液灌流以选择最有效的MSC生物反应器膜(Ph.I)；(2)制造的哨兵装置的稳定性分析(PhII)；以及(3)MSC生物反应器对心肌梗塞猪的治疗研究(Ph.II)。我们第一阶段的里程碑是鉴定透析膜，以优化MSC的效力。研究的第二阶段成果包括：(1)我们设备的运输和储存方案；(2)我们设备对健康猪的毒性评估；(3)有效治疗猪急性心肌梗死的理想时间窗口；(4)与骨髓间充质干细胞移植相比的疗效数据。随着这里描述的研究的完成，我们的生物反应器将准备好立即在人类患者身上进行测试。

 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.