ARRY Study (NCT03439514)
This is a phase II, randomized, placebo-controlled clinical trial designed to assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cardiac stem cells (CSCs) both alone and in combination (Combo), compared to placebo (cell-free Plasmalyte-A medium) as well as each other, administered by transendocardial injection in subjects with ischemic cardiomyopathy.
DREAM-HF 1 (NCT02032004)
A clinical study to evaluate the safety and accuracy of the Saranas Early Bird™ Bleed Monitoring System for the detection of endovascular procedure related bleeding events. The purpose of this research is to test if the Saranas Early Bird Bleed Monitoring System (EBBMS) can detect whether bleeding occurs during a procedure being done inside the blood vessels, and if bleeding occurs, how much bleeding occurs. (PI: Joggy George, MD)
Heart FID (NCT03037931)
OPTIMIZE IDE for the Treatment of ACS (NCT03190473)
The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study.
This study is being conducted to test the Svelte Drug Eluting Coronary Stent by comparing it to any commercially approved Abbott Vascular Xience or Boston Scientific Promus Drug Eluting Coronary Stent (control DES). The condition being studied is symptomatic ischemic heart disease, such as angina or a previous myocardial infarct, which is plaque formation in the arteries of your heart that requires treatment.(PI: Emerson Perin, MD, PhD)
Safety and Efficacy Study of VM202 in the Treatment of Chronic Non-Healing Foot Ulcers (NCT02563522)
This phase III, randomized, double-blind, placebo-controlled, multicenter, 7-month study will assess the safety and efficacy of using gene therapy via intramuscular injections of VM202 in the leg calf muscles for patients with chronic non-healing foot ulcers. (PI: Emerson Perin, MD, PhD)
The primary purpose of this study is to examine the safety and feasibility of delivering allogeneic human mesenchymal stem cells (allo-MSCs) by transendocardial injection to cancer survivors with left ventricular (LV) dysfunction secondary to anthracycline-induced cardiomyopathy (AIC).
The secondary purpose of this study is to obtain preliminary evidence for therapeutic efficacy of allo-MSCs delivered by transendocardial injection to cancer survivors with LV dysfunction secondary to AIC.
PORTICO IDE (NCT02000115)
The PORTICO clinical trial is a prospective, multi-center, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) via transfemoral and alternative delivery methods.