The objectives of this application are three fold;renew the University of Florida (UF) Regional Clinical Center (UFRCC) for the Cardiovascular Cell Therapy Research Network (CCTRN);renew the successful Investigator Training Core;and apply for the Clinical Research Coordinator Skill Development Program. Cell therapy is an exciting concept for treatment of CV disease (CVD), but despite abundant preclinical and feasibility clinical studies the ability to translate findings to improve patient outcomes has lagged. To address this need, the UFRCC utilizes established programs in Stem Cell Biology/Regenerative Medicine (T32), Bone Marrow Transplant Center (part of NIH/NCI clinical research network), novel imaging resources, the CTSI, Advanced Heart Failure/ Transplant Program, and CV Clinical Trials Program. In addition to success in CCTRN-1, we have a long record of successful collaborations in multicenter NHLBI and other trials testing strategies to improve cardiac perfusion or function and evaluate clinical outcomes. For this renewal application, we propose that enhancing progenitor cell function will improve cardiac function and lead to better clinical outcomes. Our first protocol addresses enhancing progenitor cell homing after non-STEMI. Novel features include a method to enhance binding to selectins using fucosyltransferase and its substrate (ASC-101) to complete sialylated Lewis X formation. UFRCC investigators have shown that ASC-101 enhances vasculogenesis;it has received orphan drug status for bone marrow transplantation;and is manufactured at a UF GMP-compliant facility. The second protocol uses a novel cell population (CD34+) in high dose for CAD patients with heart failure (like FOCUS). Other novel features include: increasing Angl- 7 by exposure to a small molecule shown by UFRCC investigators to enhance cell migration and vasculogenesis;a new delivery catheter (BioCardia, Helical);and cell selection method (Miltenyi Biotec). Additional unique aspects of the UFRCC include collaborations with University of Puerto Rico, and industry. This work will improve our understanding of the role of cell therapy in CVD patients.

Public Health Relevance

This is an application for a regional center to continue a collaborative network that will evaluate novel cardiovascular cellular therapies targeting our leading cause of death and major cause of disability. Two phase 1 clinical trials are proposed to provide new knowledge about the clinical role of cell therapy for heart attack and heart failure.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZHL1-CSR-O (F2))
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Ebert, Ray F
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University of Florida
Internal Medicine/Medicine
Schools of Medicine
United States
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Smith, Steven M; Gurka, Matthew J; Calhoun, David A et al. (2018) Optimal Systolic Blood Pressure Target in Resistant and Non-Resistant Hypertension: A Pooled Analysis of Patient-Level Data from SPRINT and ACCORD. Am J Med 131:1463-1472.e7
Stevens, Bruce R; Goel, Ruby; Seungbum, Kim et al. (2018) Increased human intestinal barrier permeability plasma biomarkers zonulin and FABP2 correlated with plasma LPS and altered gut microbiome in anxiety or depression. Gut 67:1555-1557
Shah, Chintan; Gong, Yan; Szady, Anita et al. (2018) Unanticipated Cardiotoxicity Associated with Targeted Anticancer Therapy in Patients with Hematologic Malignancies Patients: Natural History and Risk Factors. Cardiovasc Toxicol 18:184-191
Traverse, Jay H; Henry, Timothy D; Pepine, Carl J et al. (2018) TIME Trial: Effect of Timing of Stem Cell Delivery Following ST-Elevation Myocardial Infarction on the Recovery of Global and Regional Left Ventricular Function: Final 2-Year Analysis. Circ Res 122:479-488
Wei, Janet; Bakir, May; Darounian, Navid et al. (2018) Myocardial Scar Is Prevalent and Associated With Subclinical Myocardial Dysfunction in Women With Suspected Ischemia But No Obstructive Coronary Artery Disease: From the Women's Ischemia Syndrome Evaluation-Coronary Vascular Dysfunction Study. Circulation 137:874-876
Elgendy, Islam Y; Pepine, Carl J (2017) Systolic blood pressure target: Have we identified the optimal target yet? J Public Health Emerg 1:
Perin, Emerson C; Murphy, Michael P; March, Keith L et al. (2017) Evaluation of Cell Therapy on Exercise Performance and Limb Perfusion in Peripheral Artery Disease: The CCTRN PACE Trial (Patients With Intermittent Claudication Injected With ALDH Bright Cells). Circulation 135:1417-1428
Birkeland, Kade; Khandwalla, Raj M; Kedan, Ilan et al. (2017) Daily Activity Measured With Wearable Technology as a Novel Measurement of Treatment Effect in Patients With Coronary Microvascular Dysfunction: Substudy of a Randomized Controlled Crossover Trial. JMIR Res Protoc 6:e255
Qi, YanFei; Goel, Ruby; Kim, Seungbum et al. (2017) Intestinal Permeability Biomarker Zonulin is Elevated in Healthy Aging. J Am Med Dir Assoc 18:810.e1-810.e4
March, Keith L; Pepine, Carl J (2017) Cardiac Cell Therapy Evolving From Complex to Straightforward: Enabling Adoption and Affordability. Circ Res 121:1116-1118

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