The Cardiovascular Cell Therapy Research Network (CCTRN) I worked collaboratively to achieve its goal of successfully conducting 3 clinical trials of cell therapy: FOCUS, TIME, and LateTIME. As a Regional Clinical Center (RCC) for CCTRN I, the Texas Heart Institute (THI) contributed significantly to the development, implementation, and enrollment of the 3 trials, CCTRN I adopted our protocol, FOCUS, as one of its trials, and we shared our extensive experience in conducting clinical trials in patients with chronic heart disease as well as our expertise in performing NOGA mapping and injection procedures. THI met 100% of our recruitment goals in the CCTRN I (top in enrollment for FOCUS), aided by our innovative, multimedia campaign for patient recruitment. THI contributed significantly to the CCTRN's satellite strategy for enrollment by recruiting the first VA hospital to the network. Finally, CCTR I overwhelmingly selected our bridging protocol (cell therapy in patients with intermittent claudication) to be implemented in the latter support period. In this application, THI enthusiastically seeks to continue serving as an RCC for CCTRN II, under the leadership of James T. Willerson, MD, President and Medical Director of THI, as PI, and Emerson C. Perin, MD, PhD, Director of Research in Cardiovascular Medicine and the Stem Cell Center at THI, as co-PI. In addition to the VA satellite, THI proposes to add 2 large, strategically located satellit centers to CCTRN II-the University of Texas Southwestern Medical Center in Dallas and the John Ochsner Heart and Vascular Institute in New Orleans. We are also submitting applications for the Clinical Research Skills Development Programs.
The aim of our first research protocol is to perform the first head-to-head comparison of the effects of 3 different cell types on cardiac function and perfusion in a randomized, controlled clinical trial in patients with chronic heart disease, with the inclusion of a small tracking arm to study cell fate after delivery into the hear.
The aim of our second protocol is to conduct the first randomized, double-blind, controlled clinical trial of the safety and efficacy of stem cell therapy in patients who have the most common presentation of myocardial infarction, non-ST segment elevation myocardial infarction.

Public Health Relevance

The goal of our proposal is to advance cell therapy by conducting a comparative study of multiple cell types to help identify the most effective cell types in heart failure and by introducing cell therapy into a new, large patient population (NSTEMI patients). Also, our cell tracking studies will provide mechanistic insight into the benefits of cell therapy. We hope to achieve these aims by continuing to be part of the CCTRN II.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
5UM1HL087365-07
Application #
8443413
Study Section
Special Emphasis Panel (ZHL1-CSR-O (F2))
Program Officer
Ebert, Ray F
Project Start
2007-01-01
Project End
2019-02-28
Budget Start
2013-03-01
Budget End
2014-02-28
Support Year
7
Fiscal Year
2013
Total Cost
$776,390
Indirect Cost
$320,913
Name
Texas Heart Institute
Department
Type
DUNS #
086987831
City
Houston
State
TX
Country
United States
Zip Code
77225