INTRODUCTION

This general chapter provides a comprehensive overview of considerations for the development of cell-based advanced therapies and tissue-based products. A collection of terms commonly used in this field is provided in Glossary. Cell-based advanced therapies and tissue-based therapies are medical products that contain human or animal cells that will be administered to humans to repair, replace, regenerate, or augment a recipient’s cells, tissues, or organs that are diseased, dysfunctional, or injured. The source cells or tissues can be harvested for use without manipulation or may be propagated, expanded, pharmacologically treated, or otherwise altered in biological characteristics ex vivo before administration. The diversity of clinical indications and types of cell-based advanced therapies are shown in Table 1. Examples of tissue-based products are included in Table 2.