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

Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

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.

Evidence level

Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.

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