A breakthrough year.
Newly launched in early 2018, Texas Heart Institute’s (THI) Center for Clinical Research (CCR) supports all areas of cardiovascular clinical research, from protocol development to trial facilitation and post-trial assessment and reporting.
“This was an incredibly productive year for our team with the launch of the new Center for Clinical Research, which centralizes and focuses our talented team in the most coordinated, compliant, and efficient way possible to move important clinical trials forward for the benefit of patients.”
– Emerson Perin, MD, PhD Medical Director,
The clinical research underway at THI is vital to the fulfillment of THI’s mission. Only through ethical clinical research, and with the help of the many patients who volunteer to participate in our studies, can we gain answers to important questions about the prevention, diagnosis, and treatment of medical conditions.
The launch of the new Center for Clinical Research (CCR) marks a major milestone for THI. This dynamic team of experts provides management support for clinical research activities for all THI departments and supports outsourced clinical research activities for private-practice and academic clinicians.
The CCR team has over 200 cumulative years of research experience and over 175 years of research experience specifically at THI. In 2018, the CCR employed 18 professionals: the Medical Director, two administrators, three managers, two research nurses, four research coordinators, two recruitment coordinators, one regulatory specialist, one clinical trial management specialist, a research fellow, and a research intern. Of the CCR employees, ten are research certified through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA).
A unique quality of the CCR is the inclusion of a dedicated Recruitment Division for clinical trials. The division provides centralized recruitment of participants for all clinical research studies at THI.
During 2018, the CCR participated in 13 clinical research trials funded by industry, the National Institutes of Health (NIH), or both.
With eight new trials scheduled to start in 2019, the CCR is advancing our knowledge of clinical science and generating discoveries that will lead to the development of new therapies for treating cardiovascular diseases.
In 2018, the CCR participated in two new clinical trials to test the use of innovative devices. In one trial, the sponsor is investigating a coronary stent system carrying a fully bioresorbable drug for treating coronary artery disease. In a second trial, for a device developed at THI by Dr. Mehdi Razavi, the sponsor is investigating if this device will allow for the early detection and monitoring of bleeding complications associated with procedures that are done by accessing blood vessels.
THI was selected to participate in two new clinical trials of drug therapy in patients with heart failure. In one trial, the sponsor is investigating a drug to treat patients with dilated cardiomyopathy caused by a specific gene mutation. This form of dilated cardiomyopathy has a poor prognosis that might be improved by early treatment. In another clinical trial, the sponsor is studying a new drug treatment for patients who have heart failure with iron deficiency, which can contribute to the morbidity and mortality associated with the disease. Enrollment for these two studies commenced in 2019.
Gene Therapy Trial
Dr. Emerson Perin, THI’s Medical Director, is the national PI for a multi-center study designed to assess the safety and efficacy of intramuscular injections of an investigational gene therapy product for treating chronic non-healing foot ulcers in diabetic patients with peripheral arterial disease. Non-healing foot ulcers are an important cause of amputation in this population.
Stem Cell Trials
THI is continuing its role as a founding clinical site in the prestigious Cardiovascular Cell Therapy Research Network (CCTRN), which is funded by the National Heart, Lung, and Blood Institute section of the National Institutes of Health (NIH). The goal of the CCTRN network is to conduct collaborative stem cell therapy studies that will potentially lead to more effective, evidence-based treatment options and improved outcomes for patients with cardiovascular disease. The CCR has continued participant recruitment, enrollment, and follow-up on CCTRN studies and has helped publish results of these studies.
In 2017, through a partnership with M.D. Anderson Cancer Center, the Texas Medical Center (TMC) awarded funding for a clinical trial to further assess the effectiveness of stem cell therapy for cancer survivors with heart failure. After an investigational new drug application was submitted to the FDA in 2018, the clinical trial to test the allogeneic human mesenchymal stem cell therapy was approved to start.
Dr. Perin is continuing to pave the way for the clinical use of cell therapy in treating patients with heart failure. The first phase III stem cell study for heart failure completed enrollment in December. This study, which is designed to lay the groundwork for approval of stem cell therapy for heart failure, has generated worldwide attention and could lead to implementation of one of the first stem cell therapies to hit the market for congestive heart failure.
Training the Next Generation of Clinical Researchers
The Nursing Skills Core Training Program at THI was designed to train nurses in the specialized field of research nursing, with a focus on effective planning, coordination, use of best practices, and proper compliance for clinical trials. The fourth trainee completed the program in September 2018.
Training efforts are led by the CCR administrative team, who continue to represent THI in leadership positions across the TMC.