Darcy Lynne DiFede, RN, BSN, FAHA
Key expert in Clinical Research and Regenerative Medicine at ISSCA
Darcy Lynne DiFede, RN, BSN, FAHA, is a distinguished nurse and leader in clinical research and regenerative medicine, with over two decades of experience in academia and the biotech industry. Known for her expertise in clinical research operations, regulatory compliance, and international healthcare, Darcy has been instrumental in advancing cell-based therapies.
As Director of Clinical Operations and Regulatory Support at the University of Miami Miller School of Medicine, she led the clinical trials division at the Interdisciplinary Stem Cell Institute for nine years. There, she oversaw seven investigator-initiated trials for novel cell-based therapies targeting heart disease, enrolling over 200 patients—the largest single-center experience in the U.S. She also contributed to 16 additional trials in diverse clinical areas, collaborating with academic centers nationwide.
A Fellow of the American Heart Association (FAHA), Darcy is affiliated with the American College of Cardiology (ACC) and the Heart Failure Society of America (HFSA). She has served on the International Society for Cellular Therapy’s Cardiovascular Scientific Committee and contributed to the Cardiovascular Cell Therapy Research Network (CCTRN) through the National Heart Lung and Blood Institute (NHLBI).
Darcy has co-authored numerous publications on mesenchymal stem cell research for heart and age-related disorders, presented at international conferences, and mentored countless students and professionals in clinical research. A graduate of the University of Miami School of Nursing, her work continues to advance patient care and innovations in regenerative medicine worldwide.
