Darcy Lynne DiFede, RN, BSN, FAHA
Director

Darcy Lynne DiFede, RN, BSN, FAHA
Darcy Lynne DiFede, RN, BSN, FAHA, has more than two decades of experience in the medical science field both academic and biotech. Currently she serves as Chief Compliance Officer at Regeniself LLC. She started her own biological consulting business which led to working with world renowned experts in building hospitals in an international setting, such as Morocco. She is an expert in clinical research operations, regulatory compliance, and international and domestic healthcare. Previously, she served as director of clinical operations and regulatory support at the University of Miami Miller School of Medicine. There she was a key member and served nine years as director of research at the School of Medicine’s Interdisciplinary Stem Cell Institute, where she led the clinical trials division. During her tenure, she successfully implemented trials in several disease areas, including seven investigator-initiated clinical trials of novel cell-based therapies for heart disease, which together have enrolled more than 200 patients – the largest single center experience in the U.S. She was engaged in 16 new investigator-initiated trials in various clinical areas in collaboration with academic centers throughout the U.S. In addition to extensive clinical trial research expertise, she mentored medical students, undergraduate students, nursing students, and international nurses in the field of clinical research. Darcy served as leadership succession chair for the Beta Tau Chapter of Sigma Theta Tau International Honor Society of Nursing. She is a member of the American College of Cardiology (ACC), Heart Failure Society of America (HFSA), and a Fellow of the American Heart Association (AHA). She was appointed to the International Society for Cellular Therapy (ISCT) Cardiovascular Scientific Committee. She was a sub-investigator in the Cardiovascular Cell Therapy Research Network (CCTRN) steering committee through the National Heart Lung and Blood Institute (NHLBI). She has co-authored multiple clinical trials testing the use of mesenchymal stem cells in patients with heart or age-related disorders. She has published numerous publications and reviews in the peer reviewed literature. Darcy is internationally acknowledged, and has presented as an invited lecturer at conferences and meetings. Darcy completed her nursing education at the University of Miami, School of Nursing and Health Studies.