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Developments in Tissue Engineered and Regenerative Medicine Products by J Ludlow, J Basu

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4

Neo-Bladder: a foundational technology platform for tubular organ regeneration

Abstract

This chapter examines the development of the Neo-Bladder Augment™ and Neo-Bladder Replacement™ as illustrative examples of TE/RM product development. We describe the patient population and current need for TE/RM products for regeneration of functional, native-like urinary tissue. We briefly examine preliminary proof-of-concept studies demonstrating regeneration of functional neo-bladder, including early clinical studies in pediatric patients. We then examine in detail how these experimental successes were translated to the development of practical neo-organ products currently undergoing Phase I clinical trials. Issues arising during the development of ...

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