Cell therapy spans multiple therapeutic areas, such as regenerative medicine, immunotherapy, and cancer therapy. It typically employs autologous or allogeneic cells might involve genetic engineering or manipulations in formulation and can be administered topically or as injectables, infusions, bioscaffolds, or scaffold-free systems ( 5– 9).

Cell therapy combines stem cell- and non–stem cell-based unicellular or multicellular therapies. Today, cell therapy continues to evolve with ongoing investigations for clinical safety and efficacy, and with a global market size estimated to expand from USD 9.5 billion in 2021 to USD 23.0 billion in 2028 ( 4). The year 1889 witnessed the first practices of cell therapy by Charles-Édouard Brown-Séquard-pioneer in hormone therapy at the time-who attempted to suppress the effects of aging using injections of animal testicle extracts ( 3). Finally, we contemplate the recent attention shift toward combined therapy approaches, highlighting the factors that render multicellular therapies a more attractive option than their unicellular counterparts.Ĭell therapy refers to the transfer of autologous or allogeneic cellular material into a patient for medical purposes ( 1, 2). Besides providing the nuts and bolts of FDA policies regulating their use, we discuss the benefits of cell therapies reported in 3 therapeutic areas-regenerative medicine, immune diseases, and cancer. In this review article, we delineate the vast types of cell therapy, including stem cell-based and non–stem cell-based cell therapies, and create the first-in-literature compilation of the different “multicellular” therapies used in clinical settings.

Following the steps of their predecessor cell therapies that have become established or commercialized, investigational and premarket approval-exempt cell therapies continue to provide patients with promising therapeutic benefits in different disease areas. Cell therapy includes stem cell- and non–stem cell-based, unicellular and multicellular therapies, with different immunophenotypic profiles, isolation techniques, mechanisms of action, and regulatory levels. Cell therapy practices date back to the 19 th century and continue to expand on investigational and investment grounds.

Phase ten therapy use