Chasing the Paradigm: Clinical Translation of 25 Years of Tissue Engineering

In the past 25 years, the tissue engineering field has made incredible strides in developing tangible therapies for patients in need. Applications of the tissue engineering paradigm, involving varying configurations of cells, materials, and biochemical factors, have been explored for their regenerative capacity of virtually all tissue types. The impact and learning opportunities of current tissue engineering that inspired clinical successes are summarized. In addition, challenges associated with the translation and scale-up of therapies and replacements for complex organs, such as the heart and liver, are addressed. Platforms of research thrusts, specifically cell source, materials, fabrication, scalability, and Food and Drug Administration regulatory changes, and their respective innovations are identified for their potential to address these problems. Ideally, through their progress, tissue engineering strategies can be used to create a diverse range of easily accessible patient-specific treatments that more effectively improve quality of life. Impact Statement In this Perspective, we discuss the impact of the past 25 years of tissue engineering on the development of clinical therapies. Based on their success and other significant research accomplishments, platforms of innovation were identified. Their discoveries will enable tissue engineering inspired therapies to meet the requirements necessary for large-scale manufacturing and Food and Drug Administration (FDA) approval for a diverse range of indications.