1 Department Tissue Engineering and Regenerative Medicine, University Hospital Wuerzburg , Wuerzburg, Germany .
2 Translational Center Wuerzburg "Regenerative Therapies in Oncology and Musculoskeletal Disease," Wuerzburg, Germany .
Tissue Eng Part B Rev. 2018 Apr;24(2):155-169. doi: 10.1089/ten.TEB.2017.0305. Epub 2017 Dec 22.
Millions of people worldwide suffer from trauma- or age-related orthopedic diseases such as osteoarthritis, osteoporosis, or cancer. Tissue Engineering (TE) and Regenerative Medicine are multidisciplinary fields focusing on the development of artificial organs, biomimetic engineered tissues, and cells to restore or maintain tissue and organ function. While allogenic and future autologous transplantations are nowadays the gold standards for both cartilage and bone defect repair, they are both subject to important limitations such as availability of healthy tissue, donor site morbidity, and graft rejection. Tissue engineered bone and cartilage products represent a promising and alternative approach with the potential to overcome these limitations. Since the development of Advanced Therapy Medicinal Products (ATMPs) such as TE products requires the knowledge of diverse regulation and an extensive communication with the national/international authorities, the aim of this review is therefore to summarize the state of the art on the clinical applications of human bone marrow-derived stromal cells for cartilage and bone TE. In addition, this review provides an overview of the European legislation to facilitate the development and commercialization of new ATMPs.
全球数百万人患有创伤或与年龄相关的骨科疾病，如骨关节炎、骨质疏松症或癌症。组织工程（TE）和再生医学是专注于开发人工器官、仿生工程组织和细胞以恢复或维持组织和器官功能的多学科领域。虽然同种异体和未来的自体移植目前是软骨和骨缺损修复的金标准，但它们都受到重要限制，例如健康组织的可用性、供体部位发病率和移植物排斥。组织工程骨和软骨产品是一种很有前途的替代方法，有可能克服这些限制。由于先进治疗药物产品（ATMP）的开发，如 TE 产品，需要对不同的法规有深入的了解，并与国家/国际当局进行广泛的沟通，因此，本文的目的是总结人骨髓基质细胞在软骨和骨 TE 中的临床应用的最新进展。此外，本文还概述了欧洲法规，以促进新 ATMP 的开发和商业化。
