Extended Cardiac Preservation

延长心脏保护

• 批准号: 6837472
• 负责人: GREGORY M FAHY
• 金额: $ 59.01万
• 依托单位: 21ST CENTURY MEDICINE, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-11-01 至 2006-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6837472
• 关键词: Cercopithecidae; biomedical automation; cryopreservation; dogs; heart circulation; heart function; heart preservation; heart transplantation; human tissue; postoperative state; quality of life; solutions; technology /technique development

DESCRIPTION (provided by applicant): The long-term objective of this project is the commercialization of a product(s) that enables a substantial improvement in human heart preservation prior to transplantation. The ability to significantly extend human clinical cardiac preservation, to 24 hours or more, would allow transcontinental prospective matching, with expected gain in clinical outcome for potentially thousands of transplant recipients. Phase I studies provided a proof-of-concept for the feasibility of an automated intermittent perfusion device, that used in conjunction with the preservation solution (URS) described in Phase I, successfully preserved canine hearts for at least 24 hours. Data from phase I also demonstrated that the use of URS alone, not in combination with intermittent perfusion, results in substantial extension of cardiac preservation when compared to current commercial preservation formulations. Based on these findings, it is now our strategy to introduce two products sequentially: first, URS as a stand alone product for cardiac preservation, and later, an intermittent perfusion device that will build on the first product release and offer yet further extension of cardiac preservation. In phase II we plan to demonstrate the utility of URS for 24 hour storage using post-transplant survival in animal models as an end point, and to investigate the limits of URS for the preservation of human hearts. It is our intention to use this body of data as evidence to persuade the FDA to grant clearance for 21st Century Medicine to proceed with multicenter, randomized human clinical trials to begin phase Ill. Additionally, in phase II, the development of the intermittent perfusion device as a powerful preservation modality will continue. Ultimately the device may become a second generation product as currently envisioned. However, it is also possible the data from human heart studies in phase II will demonstrate that intermittent perfusion with URS is indeed necessary to achieve the desired extension of human cardiac preservation. Should that be the case, the combination product, URS with an intermittent perfusion system, will be tested with greater priority.

描述（由申请人提供）：该项目的长期目标是将能够显着改善移植前人类心脏保存的产品商业化。将人类临床心脏保存时间显着延长至 24 小时或更长时间的能力将允许跨大陆前瞻性匹配，从而为潜在的数千名移植受者带来预期的临床结果收益。 I 期研究为自动间歇灌注装置的可行性提供了概念验证，该装置与 I 期中描述的保存液 (URS) 结合使用，成功保存了犬心脏至少 24 小时。第一阶段的数据还表明，与目前的商业保存制剂相比，单独使用 URS（不与间歇性灌注相结合）可显着延长心脏保存时间。基于这些发现，我们现在的策略是依次推出两种产品：首先是 URS 作为心脏保存的独立产品，其次是间歇性灌注装置，它将在第一个产品发布的基础上进一步扩展心脏保存功能。在第二阶段，我们计划以动物模型移植后存活为终点，展示 URS 在 24 小时储存方面的实用性，并研究 URS 在保存人类心脏方面的局限性。我们打算使用这些数据作为证据，说服 FDA 批准 21st Century Medicine 进行多中心、随机人体临床试验，开始 III 期临床试验。此外，在 II 期，间歇性灌注装置作为一种强大的保存方式的开发将继续进行。最终该设备可能会成为当前设想的第二代产品。然而，II 期人类心脏研究的数据也有可能证明，URS 间歇性灌注对于实现人类心脏保存的预期延长确实是必要的。如果是这种情况，组合产品 URS 与间歇性灌注系统将得到更优先的测试。