EXERCISE AND IMAGING LABORATORIES
The Magnetic Resonance Imaging (MRI) Core Lab at Johns Hopkins University
The MRI Core lab is under the direction of Joao Lima, MD. Dr. Lima is widely credited as one of the pioneers in the field, developing mainstay methods by which myocardial infarct tissue is visualized and measured using the modality. His developmental role in the field has led to him spearheading the largest population studies done to date using MR studies: the Epidemiology of Diabetes Interventions and Complications Study (EDIC) and the Multi-Ethnic Study of Atherosclerosis (MESA) Study.
In addition to EDIC and MESA, the MRI Core Lab at Johns Hopkins University has conducted the analysis for the recently published SCIPIO trial and currently serves as the Core lab for the ALLSTAR stem cell clinical trial. The MRI Core has an experienced team of physicists, imaging technologists, and quality control experts to oversee MR studies with emphasis in both cardiac and vascular realms.
To learn more about the MRI Core lab at Johns Hopkins University, please email Mohammad Ostovaneh, Research Program Manager.
Massachusetts General Hospital (MGH) Cardiopulmonary Exercise Testing (CPET) Core Laboratory
The MGH CPET Core Laboratory is under the direction of Gregory Lewis, MD. Dr. Lewis and his team have over 80 years of collective experience in CPET performance and interpretation at MGH. The CPET Core Lab performs over 700 clinical and research CPETs per year, many of which are coupled with invasive hemodynamic monitoring, echocardiography and radionuclide ventriculography. The MGH CPET Lab is a national referral center for detailed physiologic evaluations of heart failure and other cardiopulmonary conditions in which precise physiologic measurements are required.
MGH has served as the CPET core lab for multiple trials and is currently also the core lab for the NHLBI Heart Failure Network (HFN), the NHLBI-sponsored Hypertrophic Cardiomyopathy Network (HCM♥NET) upcoming VANISH Trial, as well as several industry-sponsored studies. The core lab’s approach has been informed by direct experience in caring for patients with cardiovascular diseases and designing trials in heart failure. The core lab offers innovative approaches to remote CPET equipment calibration and certification, methods to achieve uniformity in gas-exchange analysis and harmonization of cycle ergometry and treadmill testing, and approaches to confront challenges associated with interpretation of exercise gas exchange data in heart failure patients.
To learn more about the CPET, please visit the MGH CPET Core Lab website.
The CPC Clinical Research affiliated with the University of Colorado School of Medicine
Many studies that employ symptomatic or functional endpoints experience problems with endpoint variability and excessive placebo response. Each of these issues results in inconclusive data that make it difficult or impossible to interpret the effectiveness of an intervention. The CPC team has pioneered a program coined the Endpoint Quality Intervention Program (EQuIP) to effectively minimize the variability that has historically plagued multicenter cardiovascular studies with functional or symptomatic endpoints. EQuIP has decreased the variance of the treadmill endpoint in several drug, gene and cell-based studies. Aimed at ensuring data integrity throughout a clinical study, this program works throughout the life of the trial to ensure that the right endpoints are chosen and appropriately described and collected in the study documents, that effective training tools are available, (e.g. on-line training videos, procedure reference tools, electronic endpoint criteria calculators), and stresses the importance of hands-on training at the sites to improve the likelihood of trial success.
The CPC is under the direction of William Hiatt, MD. Dr. Hiatt’s academic career has focused on the clinical, educational, and research issues in peripheral artery disease (PAD). He has contributed to over 63 PAD clinical investigations. To learn more about the CPC, please visit the CPC website.
Duke Clinical Research Institute (DCRI) Imaging Program CCTRN Echocardiography Core Laboratory
The DCRI Imaging Program, which includes a multimodality core laboratory, is under the direction of Pamela S. Douglas, MD, MACC, FAHA, FASE, FAHA, Geller Professor of Research in Cardiovascular Diseases at Duke University. Dr. Douglas has more than 30 years of experience in cardiovascular and imaging research, including leading the development of nationally adopted echocardiography core lab best practice standards (J Am Soc Echocardiogr. 2009; 22:755-66).
The Imaging Program at DCRI is one of the most respected imaging clinical trial groups in the world with over 30 years experience in providing high quality conventional echocardiographic measurements, including chamber and great vessel size and volume by M-mode, single, biplane and multi-plane (3D) assessments, right and left ventricular systolic and diastolic function, pulsed-wave, continuous and color flow Doppler of all valves and cardiac pump cannulae, tissue Doppler of myocardial velocities, and systolic and diastolic intervals. Additionally, DCRI’s Imaging Program has expertise performing advanced echocardiographic measurements in the core lab setting, including multi-vendor LV and RV strain and strain rate, 3D, trans-esophageal echo, and quantitation of mitral regurgitation.
DCRI has provided high quality imaging acquisition oversight and analyses for over 25 preclinical and Phase I - IV clinical trials, encompassing nearly 9000 subjects and 50,000 echoes. Of especial relevance to the CCTRN, these numbers include four stem cell studies, four VAD studies, and six other heart failure studies, which total 2,829 subjects and 13,049 echoes.
To learn more about DCRI’s Imaging Program, go to the DCRI website.
Washington University School of Medicine (WUSM)/American College of Radiology (ACR) Positron Emission Tomography (PET) Core Laboratory
The WUSM-ACR PET Core Laboratory is under the direction of Robert J. Gropler, MD (WUSM) and Paul E. Kinahan, PhD (ACR). This partnership between the WUSM Imaging Core Laboratory (WUSM-ICL) and the ACR Imaging Core Laboratory (ACR-ICL) will serve to bring cutting-edge qualification, quality control, and analytics to PET imaging conducted in CCTRN research.
Dr. Gropler will have primary oversight responsibilities for all CCTRN PET Core Lab activities. He serves as the chief of both the Division of Radiological Sciences and the Cardiovascular Imaging Laboratory at the Mallinckrodt Institute of Radiology (MIR). For 25+ years he and his group have used PET and other advanced imaging tools to study the myocardial metabolic-functional relation, in both preclinical and clinical studies, in a host of normal and abnormal cardiac states. The WUSM-ICL has extensive experience as a cardiac PET core laboratory providing services for 55 single-center or multicenter trials. Dr. Kinahan and the ACR-ICL team will act as the infrastructure and communications hub for the CCTRN’s WUSM/ACR PET Core Laboratory. The ACR-ICL provides extensive expertise in site qualification, data transfer, quality assurance (QA), quality control (QC), communication, data management, and storage retention. The ACR-ICL will coordinate communications among participating sites, the WUSM-ICL, the CCRTN DCC, and study development teams. Dr. Kinahan, also a Professor of Radiology at the University of Washington in Seattle, will have primary oversight responsibilities for all ACR-ICL activities.
To learn more about the WUSM-ICL, please visit the WUSM Cardiovascular Imaging and Clinical Research Core Laboratory website. To learn more about the ACR-ICL, please visit the ACR-ICL PET Core Laboratory website.
CELL MANUFACTURING AND BIOSAMPLE STORAGE
The Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine
The cell processing facility at the CAGT (Houston, TX) is under the direction of Adrian Gee, MD, Biol., PhD. Dr. Gee is a professor of medicine and pediatrics and director of the GMP facilities at Baylor College of Medicine. The Center was formed in 1998 as collaboration between Baylor College of Medicine, the Methodist Hospital of Houston, and Texas Children’s Hospital. Its mission is to discover and develop novel therapies for a range of diseases, and to move basic pre-clinical discoveries into the clinical phase of development for initial evaluation in patients. The GMP facility has 22 Class 10K clean rooms and manufactures cells in support of approximately 50 INDs for internal and external investigators. The lab is accredited by both the Foundation for the Accreditation of Cellular Therapy (FACT) and the College of American Pathologists (CAP). The facility is also licensed by the US Food and Drug Administration and certified by the Clinical Laboratory Improvement Amendments (CLIA). The CAGT provides both manufacturing and quality assurance services to the CCTRN.
To learn more about the CAGT, please visit the Center for Cell and Gene Therapy website.
The Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami Miller School of Medicine
The ISCI was founded in 2007 with the primary goal to develop a leading edge organization in multidisciplinary research to support and develop basic and translational research functions within the organizational structure of the University of Miami School of Medicine. Aisha Khan, MS, MBA, is the executive director of laboratory operations. The Institute provides state of the art facilities and resources to researchers to further explore stem cells and cellular regenerative pathways. The cell manufacturing program comprises 2,500 square feet of laboratory space including four separate production suites. The facility manufactures cells in support of several INDs and is both accredited by the Foundation for the Accreditation of Cellular Therapy (FACT) and certified by the Clinical Laboratory Improvement Amendments (CLIA). The facility is registered with US Food and Drug Administration and is also in compliance with the American Association of Blood Banks (AABB) standards for cellular therapy products. The ISCI provides manufacturing services to the CCTRN.
To learn more about the ISCI, please visit the Interdisciplinary Stem Cell Institute website.
The Biorepository Core (BRC) Lab at Texas Heart Institute
The BRC is under the co-direction of Doris A. Taylor, PhD, FAHA, FACC and Adrian P. Gee, PhD, MI Biol, who have more than 20 years’ experience in the field. Dr. Taylor, an innovator in regenerative medicine, brings specific experience-related insight into the requirements for cell therapy, cell profiling, and biospecimen storage. Recognized for his work in cellular therapy, Dr. Gee oversees all quality assurance (QA) aspects of the BRC at THI. Drs. Taylor and Gee lead a team of scientists and coordinators with expertise in flow cytometry, cell function analyses, and biochemical assays who conduct the phenotyping and functional analyses.
The overall purpose of a Biorepository Core is to support the mission of the Cardiovascular Cell Therapy Research Network (CCTRN) by storing biologic specimens from patients enrolled in cell therapy trials and by conducting analyses to help advance the safe, efficacious use of cell therapy in treating cardiovascular diseases. The BRC is a 2000-square foot, state-of-the-art biosafety level (BSL)-2 facility that can provide biospecimen storage, processing, and testing on a fee-for-service basis to support the CCTRN. These services will enable the CCTRN to characterize cells used in therapeutic applications and the patient response to those cells as dictated by protocol.
To learn more about the BRC, please visit the Texas Heart Institute BRC website.