Tissue Engineered Constructs: Perspectives on Clinical Translation

Lu, Lichun; Arbit, H. M.; Herrick, James L.; Segovis, Suzanne Glass; Maran, Avudaiappan; Yaszemski, Michael J.

doi:10.1007/s10439-015-1280-0

Cited by 38 publications

(33 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…According to this, the OCP assigns through a Request for Designation the regulation of the biologic component to the most accurate office to lead the marketing approval review. 44,45 Therefore, a TBP is a device-biological combination product whose PMOA is attributable to the biological component, being overseen and approved for its marketing as biologic drug by the Office of Tissues and Advanced Therapies (OTAT).…”

Section: Regulatory Framework In the United States Of Americamentioning

confidence: 99%

A Worldwide Overview of Regulatory Frameworks for Tissue-Based Products

Oberweis

Marchal

López‐Ruiz

et al. 2020

Tissue Engineering Part B: Reviews

View full text Add to dashboard Cite

Over the past decades, a wide range of tissue-based products (TBPs) have emerged as new therapeutic alternatives to conventional approaches, giving an opportunity to treat pathologies that have not been cured yet. TBPs are constituted by living/nonliving and genetically/nongenetically modified cells or tissues, which might be combined with materials that support their structure, molecules that favor the cellular environment, and even medical devices to create functional substitutes. These medicinal products are used for the repair, replacement, restoration, or regeneration of a damaged tissue in the patient. The clinical translation of these innovative products has led to the establishment of new and comprehensive regulatory schemes by regulatory bodies. The knowledge and adaptation to these regulatory shifts is essential for the pharmaceutical industries and academia, as it promotes the development of TBPs and their approval and marketing. TBPs follow different regulatory approaches depending on the jurisdiction in which the product is intended to be marked. The European Union and United States of America have developed a clear and specific regulatory pathway for TBPs. However, in other jurisdictions, the oversight of these products remains still challenging. This review describes and updates the main legal considerations, which must be implemented throughout the marketing authorization application process of a TBP, defining the regulatory framework of the main health agencies and outlining the major differences between them.

show abstract

Section: Regulatory Framework In the United States Of Americamentioning

confidence: 99%

A Worldwide Overview of Regulatory Frameworks for Tissue-Based Products

Oberweis

Marchal

López‐Ruiz

et al. 2020

Tissue Engineering Part B: Reviews

View full text Add to dashboard Cite

show abstract

“…In recent years, the bone substitute field has evolved from the traditional one-way "bench-to-bedside" into an interactive "bench-to-bedside-and-back-again" approach [148]. The driving forces behind this interactive back-and-forth approach are currently unmet clinical needs.…”

Section: Progress In the Bsm Field-clinical Translatabilitymentioning

confidence: 99%

Pre-Clinical Evaluation of Biological Bone Substitute Materials for Application in Highly Loaded Skeletal Sites

2020

View full text Add to dashboard Cite

The development of bone substitute materials (BSMs) intended for load-bearing bone defects is highly complicated, as biological and mechanical requirements are often contradictory. In recent years, biological BSMs have been developed which allow for a more efficient integration of the material with the surrounding osseous environment and, hence, a higher mechanical stability of the treated defect. However, while these materials are promising, they are still far from ideal. Consequently, extensive preclinical experimentation is still required. The current review provides a comprehensive overview of biomechanical considerations relevant for the design of biological BSMs. Further, the preclinical evaluation of biological BSMs intended for application in highly loaded skeletal sites is discussed. The selected animal models and implantation site should mimic the pathophysiology and biomechanical loading patterns of human bone as closely as possible. In general, sheep are among the most frequently selected animal models for the evaluation of biomaterials intended for highly loaded skeletal sites. Regarding the anatomical sites, segmental bone defects created in the limbs and spinal column are suggested as the most suitable. Furthermore, the outcome measurements used to assess biological BSMs for regeneration of defects in heavily loaded bone should be relevant and straightforward. The quantitative evaluation of bone defect healing through ex vivo biomechanical tests is a valuable addition to conventional in vivo tests, as it determines the functional efficacy of BSM-induced bone healing. Finally, we conclude that further standardization of preclinical studies is essential for reliable evaluation of biological BSMs in highly loaded skeletal sites.

show abstract

“…It is also of interest that tissue-engineered products do not easily conform to either of the traditional Food and Drug Administration classification: biologics or devices ( 80 , 81 ). Combined scaffold and cell-containing devices may be in more than one classification category.…”

Section: Current Barriers To Translationmentioning

confidence: 99%

Tissue-Engineered Solutions in Plastic and Reconstructive Surgery: Principles and Practice

et al. 2017

View full text Add to dashboard Cite

Recent advances in microsurgery, imaging, and transplantation have led to significant refinements in autologous reconstructive options; however, the morbidity of donor sites remains. This would be eliminated by successful clinical translation of tissue-engineered solutions into surgical practice. Plastic surgeons are uniquely placed to be intrinsically involved in the research and development of laboratory engineered tissues and their subsequent use. In this article, we present an overview of the field of tissue engineering, with the practicing plastic surgeon in mind. The Medical Research Council states that regenerative medicine and tissue engineering “holds the promise of revolutionizing patient care in the twenty-first century.” The UK government highlighted regenerative medicine as one of the key eight great technologies in their industrial strategy worthy of significant investment. The long-term aim of successful biomanufacture to repair composite defects depends on interdisciplinary collaboration between cell biologists, material scientists, engineers, and associated medical specialties; however currently, there is a current lack of coordination in the field as a whole. Barriers to translation are deep rooted at the basic science level, manifested by a lack of consensus on the ideal cell source, scaffold, molecular cues, and environment and manufacturing strategy. There is also insufficient understanding of the long-term safety and durability of tissue-engineered constructs. This review aims to highlight that individualized approaches to the field are not adequate, and research collaboratives will be essential to bring together differing areas of expertise to expedite future clinical translation. The use of tissue engineering in reconstructive surgery would result in a paradigm shift but it is important to maintain realistic expectations. It is generally accepted that it takes 20–30 years from the start of basic science research to clinical utility, demonstrated by contemporary treatments such as bone marrow transplantation. Although great advances have been made in the tissue engineering field, we highlight the barriers that need to be overcome before we see the routine use of tissue-engineered solutions.

show abstract

Tissue Engineered Constructs: Perspectives on Clinical Translation

Cited by 38 publications

References 13 publications

A Worldwide Overview of Regulatory Frameworks for Tissue-Based Products

A Worldwide Overview of Regulatory Frameworks for Tissue-Based Products

Pre-Clinical Evaluation of Biological Bone Substitute Materials for Application in Highly Loaded Skeletal Sites

Tissue-Engineered Solutions in Plastic and Reconstructive Surgery: Principles and Practice

Contact Info

Product

Resources

About