A Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CLBS16 Delivery by Intracoronary or Retrograde Coronary Sinus Administration in Subjects with Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
This trial is designed for patients with a type of heart disease that affects the flow of blood through the tiny coronary arteries of your heart (called “coronary microvascular dysfunction”), causing you to experience angina (chest pain). There are many different medications that try to reduce angina and/or improve the function of your tiny coronary arteries, such as statins, beta-blockers or nitrates; however, when these medications no longer help with symptom control patients have limited options for treatment.
This Study is designed to test an investigational product called CLBS16, which is made of your body’s CD34+ cells, a special type of cell that may help to repair the tiny blood vessels in your body. These CD34+ cells are taken from your own blood and are sent to a special cell processing facility that “sorts” or “selects” the CD34+ cells. Your own CD34+ cells are then returned to you and injected into an artery or vein in your heart. You will not be receiving cells from other human beings – you will only receive the cells from your own body, meaning these cells are “autologous”. The main goals of this Study are to evaluate whether or not autologous CD34+ cells (from your own body) that are injected with a catheter (tube) into an artery or vein in your heart are safe and effective at improving blood flow through your coronary arteries, increasing the duration of time that you can walk on a treadmill and reducing your chest pain symptoms.
WISE pre HFpEF
Women’s Ischemia Syndrome Evaluation (WISE) Mechanisms of Coronary Microvascular Dysfunction Leading to Pre-Heart Failure with Preserved Ejection Fraction (Pre-HFpEF)
Coronary microvascular disease (sometimes called small artery disease or small vessel disease) is heart disease that affects the walls and inner lining of tiny coronary artery blood vessels that branch off from the larger coronary arteries. In coronary MVD, the heart’s tiny coronary artery blood vessels do not have plaque, but damage to the inner walls of the blood vessels that can lead to spasms and decrease blood flow to the heart muscle. The purpose of this study is to examine coronary microvascular disease. We want to know how coronary microvascular disease contributes to pre-HFpEF (a condition with inadequate heart muscle function in the setting of preserved muscle pumping) to better identify potential treatment for prevention of HFpEF.
Please contact our Clinical Trials Office for information: (352) 273-8933 firstname.lastname@example.org