Beyond the Present Constraints That Prevent a Wide Spread of Tissue Engineering and Regenerative Medicine Approaches

Abstract

Despite the success of tissue engineered medical products (TEMPs) in preclinical translational research, very few have had success in the clinical market place. This gap, referred to as the “valley of death” is due to the large number of ventures that failed to attract or retain investor funding, promotion, and clinical acceptance of their products. This loss can be attributed to a focus on a bench to bedside flow of ideas and technology, which does not account for the multitude of adoption, commercial, and regulatory constraints. The implementation of an alternative bedside to bench and back again approach permits investigators to focus on a specific unmet clinical need, defining crucial translation related questions early in the research process. Investigators often fail to accurately identify critical clinical adoption criteria due to their focus on improved patient outcomes. Other adoption criteria (such as price, time, ethical concerns, and place in the workflow) can cause a product to fail despite improved patient outcomes. By applying simplified business principles such as the build-measure-learn loop and the business model canvas to early-stage research projects, investigators can narrow in on appropriate research topics and define design constraints. Additionally, 86% of all clinical trials fail to result in Federal Drug Administration approval, resulting in significant economic burdens. On the reverse side, approval through the European Medical Agency is widely considered to be more direct but has its challenges. The Committee for Advanced Therapies within the European Medical Agency has received 22 market authorization applications for advanced therapy medicinal products, of which only 10 received authorization. A thorough understanding of the various regulatory pathways permits investigators to plan for future regulatory obstacles and potentially increase their chances of success. By utilizing a bedside to bench and back again approach, investigators can improve the odds that their research will have a meaningful clinical impact.

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“…However, several bottlenecks have hindered clinical successes in this field. 17,18 An essential component of tissue engineering is the scaffold to allow the cells to home in. It typically mimics the extracellular matrix (ECM) for maximizing tissue regeneration by providing physicochemical and biomolecular cues to the cells.…”

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“…Many challenges lie ahead for clinicians and scientists in Oto-HNS aiming to translate regenerative medicine therapies into practice. Although these therapies have been researched for decades, very few have been translated to clinical use 192021. A survey of 131 clinicians, scientists, and industry experts identified manufacturing as a key barrier to the adoption of cellular therapies, with efficacy, regulation, and cost effectiveness as other important barriers 22.…”

“…Developing and evaluating new regenerative therapies and obtaining regulatory approval is a lengthy and expensive process 20. For example, achieving clinical application of skin scaffolds—a notable scaffolding approach in tissue engineering—has taken decades 24.…”

“…Clinicians may face ethical challenges unique to regenerative medicine therapies. Use of autologous or allogeneic cells and tissues needs careful consideration of informed consent and property rights 20. Clinicians may also face patients who have been exposed to overly optimistic claims in press releases,26 media reports,27 or patient testimonials 28…”

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“…Tissue bioengineering aims to substitute, restore, or improve compromised human tissue. Commonly, the body’s own healing capacities are harnessed and guided by the artificial tissue [ 27 , 28 ].…”