Regulatory considerations for manufacturing and delivery of cell-based therapies for cardiovascular indications.

Developers of cell-based therapies intended for the treatment of cardiovascular indications must address a number of regulatory issues related to the manufacturing and delivery of living cell products to patients. This article highlights issues that must be considered regarding the cell and tissue source and ancillary materials, the development of a regulatory acceptable manufacturing process, the importance of product characterization as a measure of product quality and clinical site logistics for handling and storing living cell products. Finally, regulatory issues regarding the various delivery systems commonly used for delivery cells to cardiac tissues are touched upon.