Zeitschrift für Regenerative Medizin

Characteristics, Regulations, and Physiological Implications of Cell Therapy

Robert Heather*

Cell therapy encompasses stem cell- and non-stem cellbased, monocellular, and multicellular treatments with various immunophenotypic profiles, isolation methods, modes of action, and regulatory levels. Investigational and premarket approval-exempt cell treatments continue to offer patients promise therapeutic advantages in a variety of disease areas, building on the foundation laid by their predecessor cell therapies that have established themselves or proven commercially successful. The variety of cell treatments, both those using stem cells and those without using them, have led to the first-ever collection of the many “multicellular” therapies applied in clinical settings. The advantages of cell treatments were presented in three therapeutic areas regenerative medicine, immunological illnesses, and cancer in addition to revealing the specifics of FDA rules governing their usage.