Trial Information

The Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Bridge to Transplant Patients

Congestive heart failure is a major health problem and recent estimates indicate that
end-stage heart failure with a 2-year mortality rate of 70-80% affects over 60,000 people in
the United States each year. For these patients, treatment options are extremely limited.
Less than 3,000 heart transplants are available each year because of the severely limited
supply of donor hearts. Implantable LVADs, routinely used to support heart transplantation
patients who decompensate awaiting a donor heart, were approved by the Food and Drug
Administration (FDA) in 2002 for long-term support when heart transplantation is not an
option. Few patients, however, achieve sufficient recovery to warrant LVAD explantation and
those who do must still contend with ventricular dysfunction. MPCs are normally present in
human bone marrow and have been shown to increase the development of blood vessels and new
heart muscle cells. The purpose of this study is to determine the safety of injecting MPCs
into the heart during LVAD implantation surgery. In addition, this study will examine
whether injecting MPCs into the heart is effective at improving heart function.

This study will enroll people who are on the waiting list to receive a donor heart and who
are undergoing LVAD implantation surgery. Before the surgery, participants will be randomly
assigned to one of two groups. One group of participants will have MPCs injected into their
heart during LVAD surgery and the other group of participants will have a control solution
(placebo) injected into their heart during the surgery. A portion of heart muscle removed
during the surgery will be analyzed. Participants will be monitored by study researchers and
blood samples will be collected 12 hours after the LVAD surgery and at 1, 7, 21, 60, and 90
days after the surgery. After that, a medical history review, physical examination, and
blood collection will occur every 60 days until a heart transplant occurs or until 12 months
after the LVAD implantation, whichever comes first. Heart function testing, which will
include an echocardiogram, neuronal function testing, and a 6-minute walk test, will occur
60 and 90 days after the LVAD implantation, and every 2 months thereafter until a heart
transplant occurs or until 12 months after the LVAD implantation, whichever comes first.