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The National Heart, Lung, and Blood Institute (NHLBI) convened a working group of experts on bioengineering, stem cells, biomaterials, biomechanics, cell therapies, and tissue regeneration and vascularization on May 23, 2013 at Rockledge II in Bethesda, Maryland. The purpose of the working group was to review the state of the science and to advise the NHLBI on new research directions needed to make progress towards the development of completely biological, preferably autologous replacement (i.e., "bio-artificial") hearts which would address the shortcomings of mechanical circulatory support devices.
While mechanical circulatory support devices have become one of the primary therapies for treating advanced heart failure, heart transplantation is a preferred treatment due to the lower mortality and morbidity associated with the therapy. However, heart transplantation has limited use due to the restricted availability of approximately 2000 donor hearts in the United States per year. Ventricular assist devices (VADs), while more reliable, smaller, and more biocompatible than earlier generations, require anticoagulation, and still present substantial risks for infection, stroke, and other adverse events. Considering the limitations to current therapies, and some of the progress made in the field of tissue engineering over the past decade, some researchers have turned their attention to creating fully functional, tissue-engineered (i.e., bio-artificial) replacement hearts.
The working group reviewed and discussed (1) the current state of work on bio-artificial hearts, (2) the use of stem cells in cardiac regeneration, (3) biomaterials, vascularization, and biomechanics in cardiac regeneration and bio-artificial hearts, and (4) clinical trials in cardiac regeneration and endpoints in cell therapy trials. Following the discussions, the working group acknowledged and reached consensus on the substantial number of significant challenges for development of a bio-artificial heart. These included:
Questions that the working group raised during the discussion were:
Following the identification of challenges and questions to be answered, the working group reached consensus on the following recommendations, listed in priority order.
A manuscript is planned for publication in a peer-reviewed journal.
J. Timothy Baldwin, Ph.D., NHLBI, NIH
baldwint@nhlbi.nih.gov
A manuscript is planned for publication in a peer-reviewed journal.
Chair: Anthony J. Atala, MD, Wake Forest University School of Medicine
Members:
NHLBI Program Staff
Last Updated: Aug 2013