Symposium on Emerging Cardiac Cellular Therapies

Yale University, New Haven CT

Investigators

Abstract

DESCRIPTION (provided by applicant): This grant is submitted in support of an R-13 application for a non-recurring one day conference entitled: Emerging Cardiac Cellular Therapies: Incorporating cGMP Federal Regulations into Clinical Trials. The Symposium will be held on Thursday September 8, (pm only) and Friday September 9, 2005 (am only) at the Sheraton Inner Harbor Hotel, Baltimore, Maryland. This Symposium is designed to bring together cardiologists, blood stem cell transplanters, researchers and FDA Regulatory Agents from CBER to address the role of the following cell types used in cardiac cellular therapy for treatment of ST Segment Elevation Ml: bone marrow mononuclear cells; mobilized peripheral blood stem cells; enriched subpopulations of cells (i.e., CD34+ or CD133 cells); myoblasts; autologous cardiac stem cells; adipose tissue stem cells; mesenchymal stem cells. These cardiac cell therapy clinical trials must be conducted under the new FDA regulations related to cell therapy processing (cGMPs). To ensure investigator compliance, patient safety and to safeguard the public health, studies involving the use of the cell therapy end product raise these questions regarding current and future clinical trials. What are the latest scientific data behind the use of each cell type?; What clinical results are available for each cell type?; What processing is involved for each cell type?; Are suitable animal models available?; What is the "advertised" function of each cell type in the overall treatment of cardiac damage?; What is the appropriate regulatory framework for each cell type?; What are the biologic/device "combination product" issues that need to be addressed? Aims are: Aim 1: Gather the latest data from cardiac cell therapy clinical trials; Aim 2: Identify laboratory processes involved in various cardiac cell therapy approaches; Aim 3: Identify critical barriers to clinical cell therapy research for cardiac repair and identify pathways around those barriers; Aim 4: Engage cardiac cell therapy investigators in a dialogue about the regulatory framework for their trials; Aim 5: Publish a summary in a national Journal.