A new approach to cell therapy classification and an assessment of clinical translational challenges

Cell therapies have the potential to treat and alter the course of diseases which cannot be effectively treated by existing pharmaceuticals. Cell therapies encompass a wide range of cell types and therapeutic indications, and have been the subject of intense research for many years. They are now rapidly advancing towards successful commercial development and broader patient access.

This article proposes a novel approach to classify cell therapies based on their underlying technologies, instead of the conventional categorization by cell type. Such an approach is beneficial as the regulatory pathway and manufacturing solutions tend to align within a particular technology area, given the similarity in the methods used. This analysis includes an assessment of the advancements made by new cell therapies towards clinical translation, their ability to address clinical, regulatory, manufacturing, and reimbursement requirements, and a discussion on the challenges that still exist. We also provide our perspectives on the potential progress of the field in the future.

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