Clinical translation of personalized bioengineered implant scaffolds
摘要
Organ and tissue damage, particularly of the musculoskeletal system, is commonly encountered in the clinic and can impact patient quality of life. Reconstructive operations can be necessary to restore form and function to damaged tissues; however, available off-the-shelf products fail to meet the needs of individual patients. Personalized regenerative treatments to restore damaged tissues could potentially bring benefits to both clinicians and patients. For example, resorbable implant scaffolds can be bioengineered and customized using technologies such as 3D printing to address the specific needs of patients while offering improved clinical outcomes along with reduced surgical time and complexity. For this purpose, appropriate medical-grade materials, advanced multiscale fabrication techniques and regulatory compliance are required. In this Review, we summarize the key considerations for developing personalized bioengineered implant scaffolds, emphasizing good manufacturing practice and clinical translatability. We discuss the status of clinical translation for personalized bioengineered implants and the lessons learned from existing phase I clinical trials using craniofacial reconstruction as a model system. Additionally, we provide a framework to inform wider clinical translation with recommendations on rational biomaterial choice and design, biofabrication strategies, biofunctionalization, standardized workflow, compliance with regulatory requirements, and evaluation of benefits. Finally, we discuss the remaining challenges and provide an outlook for the translation of personalized bioengineered implant scaffolds into routine clinical practice.