A Novel Method for Reduction of Bioburden in Bone Allografts - Phase II

描述（由申请人提供）：I期资助的直接结果是开发了一种可行的骨同种异体移植物终端灭菌技术，该技术将首次允许组织库轻松处理骨组织，使其达到与医疗器械要求相同的无菌保证水平（SAL 10 -6）。灭菌出生的生物力学测试表明，我们的超临界CO2工艺保持了同种异体移植物的所有基本特征。这是第一次证明一种技术可以达到这种无菌水平，同时保持移植物的整体强度，并通过3点弯曲进行严格测试。这项技术的发展将促进骨科技术的持续创新，目前由于缺乏可行的灭菌选择而受到限制。事实上，需要不断创新，以满足超过3600万患有肌肉骨骼疾病的美国人的需求，这些疾病限制了他们的功能，每年给社会带来的成本超过1000亿美元。超临界CO2灭菌将是一种使能技术，它提供了一种与生物分子和尖端聚合物更相容的灭菌替代方案。这种灭菌技术将导致骨科技术的更广泛的多样性，既更实用，也更安全。第二阶段的资金将解决两个问题，仍然在成功商业化的过程中使用的组织库。首先是全面测试我们的方法对骨同种异体移植物产生骨诱导反应的能力的影响。第二，工艺是否有能力实现病毒灭活？有了这两个问题的答案，就可以立即提供比目前技术更安全的同种异体移植物，这可能会影响数百万同种异体移植物接受者的生命。

DESCRIPTION (provided by applicant): The direct result of phase I funding has been the development of a viable bone allograft terminal sterilization technology that will, for the first time, allow tissue banks to easily process bone tissue to a sterility assurance level equal to that called for in medical devices (SAL10-6). Biomechanical testing of sterilized born revealed that our supercritical CO2 process maintains all of the essential characteristics of the allograft. This is the first demonstration of a technology that can achieve this level of sterility while maintaining the overall strength of the graft as rigorously tested by 3 point bending. The development of this technology will facilitate continued innovation in orthopedic technologies that are currently limited by a lack of viable sterilization options. Indeed continued innovation will be required to meet the needs of the over 36 million Americans with musculoskeletal conditions that limit their ability to function, with cost to society of over 100 billion dollars annually. Supercritical CO2 sterilization will be an enabling technology by offering a sterilization alternative that is more compatible with biological molecules and cutting edge polymers. This sterilization technology will result in a wider diversity of orthopedic technologies that are both more functional and safer. Phase II funding will address the two questions that remain before the successful commercialization of the process for use in tissue banks. First is the comprehensive testing of the impact of our process on the ability of bone allografts to generate osteoinductive responses. Second, is the ability of the process to achieve viral inactivation? With these two questions answered the way will be cleared to immediately provide for safer allografts than current technology allows for, potentially impacting the lives of millions of allograft recipients.