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Purpose <p>Upper airway pathology (including the larynx and trachea) arising from malignancies, traumatic injuries, or congenital anomalies often need complex surgical interventions and significantly impact quality of life. Three-dimensional (3D) printing has emerged as a promising technology offering patient-specific airway implants and reconstructive solutions tailored to individual anatomical and pathological requirements. Acellular 3D printed scaffolds demonstrate particular promise due to their regulatory and translational advantages.</p> Findings <p>Literature search on Pubmed targeting 3D printed airway scaffolds identified 98 relevant studies from 2012 to 2025, revealing notable advancements, particularly progression of acellular airway stents to formal FDA Investigational Device Exemption (IDE) trials. Acellular scaffolds have shown superior translational potential due to simplified regulatory pathways versus complex biologic-device combination requirements for cell-laden constructs. Despite extensive research efforts encompassing over a hundred in vitro and in vivo studies, a substantial translational gap exists. Limited long-term large animal studies and no successful 3D bioengineered replacement procedures in humans have been reported to date. This review emphasizes the importance of designing 3D printed implants through careful consideration of scaffold-specific features such as nano-topography and porosity gradients to achieve immunomodulation, enhance tissue integration, and functionality.</p> Summary <p>While 3D printed scaffolds show promise for airway reconstruction, several scientific, regulatory, and clinical hurdles persist before these can be widely used. Sustained interdisciplinary collaboration among bioengineers, scientists, clinicians, regulatory specialists, and industry partners is essential to bridge this translational gap and realize the transformative potential of 3D printed implants for patients with airway dysfunction.</p>

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Toward Clinical Translation of 3D-Printed Scaffolds in Upper Airway Reconstruction: Insights, Design Considerations, and Challenges

  • 期刊论文

  • 发表日期：

    2025年8月28日

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  • Sriya Yeleswarapu,
  • Cheryl E. Myers,
  • Amanda M. Richards,
  • Juergen Neubauer,
  • Danielle N. Grandjean,
  • Dominique B. Hoelzinger,
  • David G. Lott

摘要

Purpose

Upper airway pathology (including the larynx and trachea) arising from malignancies, traumatic injuries, or congenital anomalies often need complex surgical interventions and significantly impact quality of life. Three-dimensional (3D) printing has emerged as a promising technology offering patient-specific airway implants and reconstructive solutions tailored to individual anatomical and pathological requirements. Acellular 3D printed scaffolds demonstrate particular promise due to their regulatory and translational advantages.

Findings

Literature search on Pubmed targeting 3D printed airway scaffolds identified 98 relevant studies from 2012 to 2025, revealing notable advancements, particularly progression of acellular airway stents to formal FDA Investigational Device Exemption (IDE) trials. Acellular scaffolds have shown superior translational potential due to simplified regulatory pathways versus complex biologic-device combination requirements for cell-laden constructs. Despite extensive research efforts encompassing over a hundred in vitro and in vivo studies, a substantial translational gap exists. Limited long-term large animal studies and no successful 3D bioengineered replacement procedures in humans have been reported to date. This review emphasizes the importance of designing 3D printed implants through careful consideration of scaffold-specific features such as nano-topography and porosity gradients to achieve immunomodulation, enhance tissue integration, and functionality.

Summary

While 3D printed scaffolds show promise for airway reconstruction, several scientific, regulatory, and clinical hurdles persist before these can be widely used. Sustained interdisciplinary collaboration among bioengineers, scientists, clinicians, regulatory specialists, and industry partners is essential to bridge this translational gap and realize the transformative potential of 3D printed implants for patients with airway dysfunction.