(Bio)manufactured Solutions for Treatment of Bone Defects with Emphasis on US-FDA Regulatory Science Perspective.

Autor: Ghelich P; Department of Biomedical Engineering, University of Connecticut, Farmington, Connecticut, 06030, USA., Kazemzadeh-Narbat M; Musculoskeletal Clinical Regulatory Advisers (MCRA), Washington DC, US., Najafabadi AH; Department of Biomedical Engineering, University of Connecticut, Farmington, Connecticut, 06030, USA., Samandari M; Department of Biomedical Engineering, University of Connecticut, Farmington, Connecticut, 06030, USA., Memic A; Center of Nanotechnology, King Abdulaziz University, Jeddah, 21589 Saudi Arabia., Tamayol A; Department of Biomedical Engineering, University of Connecticut, Farmington, Connecticut, 06030, USA.
Jazyk: angličtina
Zdroj: Advanced nanobiomed research [Adv Nanobiomed Res] 2022 Apr; Vol. 2 (4). Date of Electronic Publication: 2022 Jan 05.
DOI: 10.1002/anbr.202100073
Abstrakt: Bone defects, with second highest demand for surgeries around the globe, may lead to serious health issues and negatively influence patient lives. The advances in biomedical engineering and sciences have led to the development of several creative solutions for bone defect treatment. This review provides a brief summary of bone graft materials, an organized overview of top-down and bottom-up (bio)manufacturing approaches, plus a critical comparison between advantages and limitations of each method. We specifically discuss additive manufacturing techniques and their operation mechanisms in detail. Next, we review the hybrid methods and promising future directions for bone grafting, while giving a comprehensive US-FDA regulatory science perspective, biocompatibility concepts and assessments, and clinical considerations to translate a technology from a research laboratory to the market. The topics covered in this review could potentially fuel future research efforts in bone tissue engineering, and perhaps could also provide novel insights for other tissue engineering applications.
Databáze: MEDLINE