Chapter 87 - Regenerating Kidney Structure and Function: An Industry Perspective

Abstract

Recent progress toward the application of tissue engineering methodologies for the regeneration of tubular and solid organs including the kidney is identifying shared methodologies that may underlie the development of foundational platform technologies broadly applicable toward the regeneration of multiple organ systems. Central themes emerging for both tubular and solid neo-organs include the application of a biodegradable scaffold to provide structural support for developing neo-organs and the role of committed or progenitor cell populations in establishing the regenerative micro-environment of key secreted growth factors, constitutive components of the regenerated tissue and extra-cellular matrix critical for catalyzing de novo organogenesis. However, aspects of these strategies currently under active development for tissue engineering of neo-organs may not be relevant for successful commercialization as novel TE/RM products for clinical application. For example, difficulties in large scale sourcing and quality control of biomaterials derived from decellularization of cadaveric organs imply that such biomaterials may be less suitable for incorporation into TE/RM products when compared to biomaterials of synthetic origin. Similarly, TE/RM technologies that attempt to leverage populations of stem and progenitor cells are less likely than platforms focused on committed cell populations or acellular biomaterials to facilitate rapid development of viable products. In this chapter, we present our experience in the development of RegenMedTX LLC’s Neo-Kidney Augment to identify elements of this foundational organ regeneration technology platform that may be broadly applicable toward the design and development of additional solid neo-organ products. We will focus specifically on highlighting aspects of this neo-organ regenerative platform conducive to the commercial viability of this technology.