Stem Cell Bioreactor for Cardiac Care

 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。

 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.