Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products Proceedings of a Workshop (2019) / Chapter Skim
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1 Introduction and Overview
1 Introduction and Overview
Pages 1-8
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The term "regenerative engineering" reflects a new understanding of the use of tissue engineering for regeneration and also the growing number of research and product development efforts that incorporate elements from a variety of fields. Because regenerative engineered therapies rely on live cells and scaffolds, there are inherent challenges in quality control arising from variability in source and final products.
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The agenda for the workshop was developed by an independent planning committee.2 Invited speakers and participants discussed factors and sources of variability in the development and clinical application of regenerative engineering products, characteristics of highquality products, and how different clinical needs, models, and contexts can inform the development of a product. Speakers also discussed approaches to reducing variability and ensuring consistent, high-quality products and thereby improving patient outcomes.
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DEVELOPING REGENERATIVE ENGINEERING PRODUCTS To set the stage for discussion, Guillermo Ameer, the director of the Center for Advanced Regenerative Engineering at Northwestern University, and Cato Laurencin, the chief executive officer of the Connecticut Convergence Institute for Translation in Regenerative Engineering and the director of the Raymond and Beverly Sackler Center for Biomedical, Biological, Engineering and Physical Sciences at the University of Connecticut, provided a brief background on the field of regenerative engineering and the impact of variability on regenerative engineering products. The origins of regenerative medicine, Ameer said, can be traced back to ancient Greece (around 330 BC)
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. While those who work in regenerative engineering might use slightly different definitions, Laurencin said, the constant theme of the field is "the convergence of advanced materials science, stem cell science, physics, and developmental biology, and clinical translation toward the regen BOX 1-2 Definition of Regenerative Engineeringa For the purposes of workshop planning, the planning committee used the followng definition (as included on the workshop agenda)
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Ameer listed several ongoing activities that are supporting the development of this new concept. The Regenerative Engineering Society publishes the Regenerative Engineering and Translational Medicine Journal and hosts a range of events, including a "Rock Stars of Regenerative Engineering" conference.3 Ameer also noted that the fall 2018 meeting of the Materials Research Society will include regenerative engineering sessions.4 As an example of this convergence of disciplines in practice, Ameer described efforts at his institution, the Center for Advanced Regenerative Engineering at Northwestern University.5 This new initiative is a partnership among the McCormick School of Engineering at Northwestern and more than 40 other members, including the Feinberg School of Medicine (Northwestern University)
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Examples of Regenerative Engineering Approaches Ameer shared several brief examples of current research in regenerative engineering to illustrate both the potential of the field to advance medicine and the challenges of developing and translating regenerative engineering products. Smart Scaffolds for Bladder Regeneration Children born with spina bifida have numerous lower peripheral nervous system complications, Ameer said.
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Factors That Impact Variability Ameer offered his thoughts on the factors that can lead to variability in regenerative engineering products and that need to be understood in order to successfully manufacture cell and tissue products for regenerative medicine. Among the factors that affect the cells and tissue used in the products are the characteristics of the donor source, such as specifics of the donor's immune system, disease stage, medications, age, sex, ethnicity, and biologic heterogeneity.
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. The next session discussed developing appropriate metrics and outcome measures for clinical trials to facilitate regulatory review and approval as well as regulatory programs that are available to help bring these products through development (Chapter 6)
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