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.

Manufacturing considerations for clinical uses of therapies derived from stem cells.

Manufacturing a therapeutic cell-based product from a stem cell source is far from simple. Regulatory authorities expect that the donor source of the stem cells is appropriately screened and tested for human pathogens. All of the synthetic or animal-derived ancillary materials must be appropriately qualified and tested before use in clinical manufacturing.

FDA regulation of allogeneic islets as a biological product.

This article describes the Food and Drug Administration's recent manufacturing review experience with investigational new drug applications submitted for allogeneic pancreatic islets of Langerhans for the treatment of type 1 diabetes mellitus. In addition, considerations of islet preparation issues that will need to be resolved before the submission of a biologics license application are discussed.

Selected Food and Drug Administration review issues for regulation of allogeneic islets of langerhans as somatic cell therapy.

The Food and Drug Administration has seen a significant increase in investigational new drug (IND) applications for the use of allogeneic islets of Langerhans to treat type 1 diabetes mellitus. The current regulatory framework for clinical use of allogeneic islets of Langerhans is described. In addition, expectations and considerations for information to be included in the manufacturing, preclinical, and clinical sections of an IND for allogeneic islets of Langerhans to treat type 1 diabetes mellitus are discussed.