Method to evaluate and quantify myocardial injections

直接心肌内注射可以允许局部递送蛋白质和基因治疗剂， 心肌和冠状动脉疾病。然而，人们对这一事件的直接命运知之甚少。 通过经皮肌内膜导管或通过外科心外膜注射给予材料。未识别的注射材料损失可能会对临床前试验的结果产生负面影响。这个问题长期以来一直被药物开发商和药物输送系统开发商私下讨论。最近的出版物表明，心肌保留的注射材料可以有很大的不同。我们假设可以开发一种商业试剂，以提供体内模型中心脏药物递送系统的检测和定量，并提供在双盲动物试验中唯一识别实验亚组的方法。此外，该试剂可用作教学工具，并作为心肌注射技术的临床医生认证手段。我们的第一阶段应用开发了一套试剂，同时标记了稳定同位素和荧光标记物。我们的II期申请寻求支持，以评估这些试剂在适当的体内模型中的有用性，并寻求支持，通过添加磁共振成像（MIR）组件来进一步开发我们的基础技术。

Direct intramyocardial injection may permit local delivery of protein and gene therapy agents for myocardial and coronary artery disease. However, little is known about the immediate fate of materials administered via percutaneous endomyocardial catheters or viasurgical epicardial injection. Unrecognized loss of injected material can negatively influence the outcome of a preclinical trial. This problem has long been privately discussed by both pharmaceutical developers and developers of drug delivery systems. A recent publication demonstrates that myocardial retention of injected material can vary greatly. We hypothesize that a commercial reagent can be developed to provide both detection and quantitation of cardiac drug delivery systems in in vivo models, as well as provide the means to uniquely identify experimental subgroups dudng double-blind animal trials. In addition, this reagent can be used as a teaching tool and as a means to certify clinicians in myocardial injection techniques. Our Phase I application develop a set of reagents, co-labeled with both a stable isotope and a fluorescent marker. Our Phase II application seeks support to evaluate the usefulness of these reagent in appropriate in vivo models and seeks support to further develop our base technology by the addition of a magnetic resonance imaging (MIR) component.