Sept. 29, 2016
CHARLESTON, SC – The Ralph H. Johnson VA Medical Center, in partnership with the Medical University of South Carolina (MUSC), will begin a new cardiac stem cell clinical trial for veterans and civilians affected by heart failure with preserved ejection fraction, a common but typically difficult to treat heart disease. The trial is one of five research projects funded through a $10 million Department of Defense grant, initiated by the Congressionally Directed Medical Research Program, awarded to Cedars-Sinai Heart Institute in Los Angeles.
In March 2016, a study conducted at Cedars-Sinai was published in the Journal of the American College of Cardiology Basic and Translational Science, demonstrating that weeks after infusions of cardiosphere-derived cells (CDCs), fibrosis in the hearts of laboratory rats with hypertension and heart failure with preserved ejection fraction was “melted away like hot water on a sugar cube,” said Michael Zile, M.D., Charleston VAMC Cardiology physician and principal investigator of the clinical trial in Charleston.
Following the publication of the study, the FDA approved Cedars-Sinai’s proposal for the clinical trial as a collaborative effort between the Ralph H. Johnson VA Medical Center, MUSC, the Cedars-Sinai Heart Institute and Capricor, a Los Angeles-based biotechnology company.
“The goal is to attract as many veterans as possible to this trial because this is a common, important, and devastating disease process that our veterans suffer from,” said Zile. “This novel therapy, if successful, will be useful for our veterans, and improve the quality of their life and their survival.”
The trial is scheduled to begin next month and aims to enroll 40 patients. Twenty patients will receive the stem cells and 20 patients will be given a placebo. The studies will be conducted by VA employees with the assistance of two DOD research coordinators who are funded directly through the grant. As part of the close affiliation agreement between the Ralph H. Johnson VA Medical Center and MUSC, all veteran and civilian participants will receive treatment at MUSC for patient convenience.
With approximately three million people - more than half the nation’s total heart failure patients - suffering from this type of heart failure in the U.S., this clinical trial has the potential to positively affect millions of people. Patients with this condition experience fibrosis, similar to scaring, in the heart muscles which in turn prevents the pumping chambers from filling with blood properly. This disease is devastating; 50 percent of those suffering from the disease die within five years of the initial diagnosis and each patient has a 50 percent chance they will be hospitalized with heart failure every six months.
“At this moment there are no specific, effective therapies in heart failure preserved ejection fraction that will reduce the disability these patients have, reduce the chance they’ll be admitted to the hospital for treatment, or increase their survival rate,” Zile said. “It’s for this reason that Dr. Sheldon Litwin [a trial collaborator, University adjunct professor and director of the VA Echo Lab] and I are making efforts to explore these novel therapies. There is an enormous unmet need in this area of cardiology in 2016.”
During the trial, CDCs will be injected inside of patients’ coronary arteries and migrate into the heart muscle. Zile explained that the trial in Charleston is pivotal to the other four, more basic, studies funded through the grant because it tests the utility of CDC therapy in humans.
“We know CDCs do not raise significant safety concerns because more than 100 patients have been given these stem cells for treatment of other diseases,” he said. “The question here is, are they an effective treatment for heart failure with preserved ejection fraction? We hope that the CDCs deliver an effective treatment that corrects what caused the heart to fail in the first place.”
To be considered as a candidate for this clinical trial, contact clinical coordinator Linsey Stewart, RN, at 843-792-1238. Individual patients will be monitored closely with face-to-face appointments for six months, and follow-ups via phone for the duration of the three-year study.
About the Ralph H. Johnson Va Medical Center
Located in historic downtown Charleston, South Carolina, the Ralph H. Johnson VA Medical Center is a tertiary care teaching hospital providing the highest level quality care from cardiology to neurology to primary and mental health care for more than 67,000 Veterans along the South Carolina and Georgia coast. The Ralph H. Johnson VA achieved a 5-Star rating according to VA’s Strategic Analytics for Improvement and Learning Value (SAIL) model, and is the fifth fastest growing VA in the U.S. for percentage patient growth. This rating, which ranks the Charleston VA in the top 10 percent of VA medical centers nationwide for quality of care and efficiency, was first achieved by the Charleston VA in October 2014. The Charleston VA is also ranked in the top 10 percentile according to the Health care Effectiveness Data and Information Set (HEDIS). HEDIS is an independent review that measures performance of 90 percent of America’s health plans and facilities in both the public and private sector on dimensions of care and service. The Ralph H. Johnson VA Medical Center is a center of excellence for robotic surgery and orthopedics, and is the first VA National Tele-Mental Health Hub providing care for Veterans across the U.S. The 149-bed hospital includes six community based outpatient clinics, a 20-bed nursing home, women’s health, and the full range of inpatient and outpatient care including medical and surgical intensive care. The VAMC provides more than 700,000 outpatient visits and approximately 3,800 inpatient stays annually. With more than 2,500 employees, Charleston VA has an annual budget of $397 million, research funding of more than $20 million, and more than 100 principle investigators participating in approximately 300 research studies. For more information, visit Ralph H. Johnson VA Medical Center.
About the Medical University Of South Carolina
The Medical University of South Carolina (MUSC) has grown from a small private medical school founded in 1824 into one of the nation’s top academic health science centers, with a 700-bed medical center (MUSC Health) and six colleges. As South Carolina’s only comprehensive academic health center providing a full range of programs in the biomedical sciences, MUSC is engaged in activities statewide. Its campus is located on more than 80 acres in the city of Charleston, with an overall population of about 13,000 clinicians, faculty, staff and students. Nearly 3,000 students in six colleges (Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing, and Pharmacy) study for degrees at the baccalaureate, masters, doctoral, and other professional levels. The University also provides residency training for more than 500 graduate health professionals. The teaching staff is comprised of more than 1,500 full and part-time faculty.
About MUSC Health
MUSC Health is the clinical enterprise of the Medical University of South Carolina (MUSC) comprised of a 700-bed Medical Center, the MUSC College of Medicine and the physician’s practice plan. It serves patients across South Carolina and beyond through four hospital facilities in Charleston and more than 100 outreach sites. Among these are the Hollings Cancer Center, a National Cancer Institute-designated center and the only one of its kind in South Carolina, and a nationally recognized Children’s Hospital. The Medical University was founded in 1824 and has become a premiere academic health sciences center at the forefront of the latest advances in medicine, with world-class practitioners and scientists providing groundbreaking research and technology that is often the first of its kind in the world.