Tissue Engineering Evaluation Criteria for Musculoskeletal Tissue Repair

摘要 在过去的二十年里，组织工程学在学术界和工业界已经成为一种令人兴奋的、 多学科领域提供修复或再生受伤和患病的肌肉骨骼的潜力 以及带有活组织的头面部组织。随之而来的是分配资源的需求 并在相互竞争的方法中进行选择。这一挑战提出了关于用于 评估不同的方法。哪些方法值得资助，应该采用什么标准 监督他们的成功？应该测量哪些参数，这些参数应该是什么值 参数有吗？我们建议召开一次为期两天的会议，让生物工程师齐聚一堂， 外科医生、生物学家、材料科学家和商业开发专家：1)仔细地重新 检查组织工程的一般目标和特定于组织的目标；2)确定标准和优先顺序 这些组织工程修复的设计和评估的阈值；以及3)确定需求 在临床前研究中更快地实现我们的目标。整个小组将在#年开始开会。 每天就设定目标、标准和阈值的过程达成一致，然后在 共享结果以确定这些参数在不同组织类型中的共同特征的日子。 参赛者还将被分配到六个特定组织团队(韧带、肌腱、骨骼、关节)中的一个 软骨、半月板/TMJ和椎间盘)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、评估参数和 评估特定组织修复的标准，确定我们相对于这些目标的位置和可能性 可接受性的阈值，并检查疗效、手术处理和附件、成本等问题 制造，以及临床前和临床试验的预计时间。通过不断质疑我们的 在此过程中，我们应该能够更好地评估有前景的组织工程方法， 帮助资助机构最有效地将其可用的研究资金用于组织工程， 并加快开发有用的产品投入临床使用。

Abstract 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 ¿ day conference that will bring together bioengineers, surgeons, biologists, material scientists, and experts in commercial development to: 1) carefully re- examine 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.