Tissue Engineering Evaluation Criteria for Musculoskeletal Tissue Repair

描述（由申请人提供）：在过去的二十年中，组织工程在学术界和工业界已经成为一个令人兴奋的多学科领域，提供了用活组织修复或再生受伤和患病的肌肉骨骼和颅面组织的潜力。随着这项活动的开展，需要分配资源，并在相互竞争的办法中作出选择。这一挑战提出了用于评估不同方法的标准问题。哪些方法值得供资，应采用什么标准来监测其成功？应该测量哪些参数，这些参数应该具有什么值？我们建议举办一个为期两天半的会议，将生物工程师，外科医生，生物学家，材料科学家和商业开发专家聚集在一起：1）仔细重新审查组织工程的一般和组织特异性目标; 2）确定和优先考虑这些组织工程修复的设计和评估标准和阈值;以及3）确定临床前研究的需求，以更快地实现我们的目标。整个小组将在每天开始时开会，就设定目标、标准和阈值的过程达成一致，然后在一天结束时分享结果，以确定这些参数在不同组织类型中的共同特征。参与者还将被分配到六个组织特定的团队（韧带，肌腱，骨骼，关节软骨，半月板/TMJ和椎间盘）之一，其中包括至少一名生物工程师，外科医生，生物学家和材料科学家。每个团队将讨论总体目标和临床需求，评估特定组织修复的评估参数和标准，确定我们相对于这些目标的位置和可接受性的可能阈值，并检查疗效，手术处理和附件，制造成本以及临床前和临床试验的预计时间。通过不断地质疑我们的进展沿着，我们应该能够更好地评估有前途的组织工程方法，协助资助机构最有效地利用他们在组织工程方面的研究资金，并加快有用产品的临床应用的开发。

DESCRIPTION (provided by applicant): In the last two decades, tissue engineering in academia and industry has become an exciting, multidisciplinary field offering the potential to repair or regenerate injured and diseased musculoskeletal and craniofacial tissues with living tissues. With this activity has come the need to allocate resources and choose among competing approaches. This challenge raises questions about criteria used to assess differing approaches. Which approaches are worth funding and what criteria should be used to monitor their success? Which parameters should be measured and what values should these parameters have? We propose to conduct a 2 1/2 day conference that will bring together bioengineers, surgeons, biologists, material scientists, and experts in commercial development to: 1) carefully reexamine general and tissue-specific goals for tissue engineering; 2) identify and prioritize criteria and threshold values for the design and evaluation of these tissue engineered repairs; and 3) identify needs in pre-clinical research to more rapidly achieve our goals. The entire group will meet at the beginning of each day to agree on the process for setting goals, criteria, and threshold values, and then at the end of the day to share results so as to identify common features of these parameters across tissue types. Participants will also be assigned to one of six tissue-specific teams (ligament, tendon, bone, articular cartilage, meniscus/TMJ and intervertebral disc) to include at least one bioengineer, surgeon, biologist, and material scientist. Each team will discuss overall goals and clinical needs, evaluative parameters and criteria for evaluating a specific tissue repair, establish where we are relative to these goals and possible threshold values of acceptability, and examine issues of efficacy, surgical handling and attachment, cost to manufacture, and projected times to preclinical and clinical trials. By continually questioning our progress along the way, we should be able to better assess promising tissue engineering approaches, assist funding agencies to most effectively spend their available research dollars in tissue engineering, and speed the development of useful products to clinical use.