Regulation, Production, and Distribution of Neo‐organs

Abstract

Replacing diseased tissues and organs represents a significant unmet medical need. Limited supply and complications such as chronic metabolic alterations, rejection, and limited product shelf‐life have rendered organ transplantation a costly and risky approach. Autologous organ replacement may be a less risky approach. Neo‐organs and neo‐tissues produced from a patient's own cells ex vivo provide a foundation to harness the body's ability to regenerate. Organ or tissue function is restored by the regenerative healing that follows implantation. These products may fulfill a significant unmet medical need for patients who have partial or complete organ loss. Recent scientific advances in tissue engineering technologies and their use in regenerative medicine have helped us better understand host tissue healing responses. These advances have allowed product development to fit into existing and emerging regulatory guidelines and remain commercially viable. Neo‐organ production requires defined raw materials and a reproducible manufacturing process where the appropriate constituents can be brought together ex vivo to form an implantable neo‐organ product. Advancements in the science, technology, and production of regenerative medical products have revealed fundamental and shared aspects from which generalizations about approaches to development and regulatory pathways can be made.