Factors affecting the Turnaround Time for Manufacturing Testing and Release of Cellular Therapy Products prepared at Multiple Sites in support of Multicenter Cardiovascular Regenerative Medicine Protocols – a Cardiovascular Cell Therapy Research Network (CCTRN) Study

摘要

BACKGROUNDCellular therapy studies are often conducted at multiple clinical sites in order to accrue larger patient numbers. In many cases this necessitates use of localized Good Manufacturing Practices (GMP) facilities to supply the cells. To assure consistent quality, oversight by a quality assurance group is advisable. In this study we report the findings of such a group established as part of the Cardiovascular Cell Therapy Research Network (CCTRN) studies involving use of autologous bone marrow mononuclear cells (ABMMC) to treat myocardial infarction and heart failure.