PDF(Pubmed)
Abstract：
UNASSIGNED: Tissue engineering is a multidisciplinary field that combines principles from cell biology, bioengineering, material sciences, medicine and surgery to create functional and viable bioproducts that can be used to repair or replace damaged or diseased tissues in the human body. The complexity of tissue engineering can affect the prospects of efficiently translating scientific discoveries in the field into scalable clinical approaches that could benefit patients. Organizational challenges may play a key role in the clinical translation of tissue engineering for the benefit of patients.
UNASSIGNED: To gain insight into the organizational aspects of tissue engineering that may create impediments to efficient clinical translation, we conducted a retrospective qualitative case study of one tissue engineering multi-site translational project on knee cartilage engineered tissue grafts. We collected qualitative data using a set of different methods: semi-structured interviews, documentary research and audio-visual content analysis.
UNASSIGNED: Our study identified various challenges associated to first-in-human trials in tissue engineering particularly related to: logistics and communication; research participant recruitment; clinician and medical student participation; study management; and regulation.
UNASSIGNED: While not directly generalizable to other types of advanced therapies or to regenerative medicine in general, our results offer valuable insights into organizational barriers that may prevent efficient clinical translation in the field of tissue engineering.
UNASSIGNED: To gain insight into the organizational aspects of tissue engineering that may create impediments to efficient clinical translation, we conducted a retrospective qualitative case study of one tissue engineering multi-site translational project on knee cartilage engineered tissue grafts. We collected qualitative data using a set of different methods: semi-structured interviews, documentary research and audio-visual content analysis.
UNASSIGNED: Our study identified various challenges associated to first-in-human trials in tissue engineering particularly related to: logistics and communication; research participant recruitment; clinician and medical student participation; study management; and regulation.
UNASSIGNED: While not directly generalizable to other types of advanced therapies or to regenerative medicine in general, our results offer valuable insights into organizational barriers that may prevent efficient clinical translation in the field of tissue engineering.
摘要：
■组织工程是一个多学科领域，结合了细胞生物学的原理，生物工程,材料科学,药物和手术，以创造功能和可行的生物制品，可用于修复或替换人体内受损或患病的组织。组织工程的复杂性会影响将该领域的科学发现有效转化为可扩展的临床方法的前景，从而使患者受益。组织挑战可能在组织工程的临床转化中起关键作用，以造福患者。
■为了深入了解组织工程的组织方面，这些方面可能会阻碍有效的临床翻译，我们进行了一项针对膝关节软骨工程组织移植物的组织工程多部位转化项目的回顾性定性病例研究。我们使用一组不同的方法收集定性数据：半结构化访谈，文献研究和视听内容分析。
■我们的研究确定了与组织工程中首次人体试验相关的各种挑战，特别涉及：后勤和沟通；研究参与者招募；临床医生和医学生参与；研究管理；和监管。
■虽然不能直接推广到其他类型的先进疗法或一般的再生医学，我们的研究结果为组织障碍提供了有价值的见解,这些障碍可能会阻碍组织工程领域的有效临床转化.
■为了深入了解组织工程的组织方面，这些方面可能会阻碍有效的临床翻译，我们进行了一项针对膝关节软骨工程组织移植物的组织工程多部位转化项目的回顾性定性病例研究。我们使用一组不同的方法收集定性数据：半结构化访谈，文献研究和视听内容分析。
■我们的研究确定了与组织工程中首次人体试验相关的各种挑战，特别涉及：后勤和沟通；研究参与者招募；临床医生和医学生参与；研究管理；和监管。
■虽然不能直接推广到其他类型的先进疗法或一般的再生医学，我们的研究结果为组织障碍提供了有价值的见解,这些障碍可能会阻碍组织工程领域的有效临床转化.
