Research & Clinical Trials : Trials

Trials

Visit the U Health clinical trial website for information on all active trials in the U Health system.

Below is a list of all our current trials:

Enrollment Status Study Title Phase Contact CT.GOV identifier
Active, Enrolling CRATUS: A Phase I/II, Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients with Aging Frailty. I/II Darcy DiFede 305-243-9106 NCT02065245
Active, Enrolling ELPIS: Allogeneic Human MEsenchymal Stem Cell (hMSC) Injection in Patients with Hypoplastic Left Heart Syndrome. I Darcy DiFede 305-243-9106 or Cindy Delgado 305-243-7444 NCT02398604
Active, Enrolling Hyperion: A Comparative study of subjects tHree to nine Years Past thEiR fInal follow-ON Study visit. N/A Darcy DiFede 305-243-9106 or Cindy Delgado 305-243-7444 N/A
Enrollment Complete Aether: A Phase I, Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients with Idiopathic Pulmonary Fibrosis. I Marilyn Glassberg 305-243-7888 NCT02013700
Enrollment Complete Poseidon DCM: A Phase I/II Randomized Pilot Study of the Comparative Safety and Efficacy of Transendocardial Injection of Autologous Mesenchymal Stem Cells Versus Allogeneic Mesenchymal Stem Cells in Patients With Nonischemic Dilated Cardiomyopathy. I/II Darcy DiFede 305-243-9106 NCT01392625
Enrollment Complete POSEIDON: A Phase I/II, randomized pilot study of the comparative safety and efficacy of transendocardial injection of autologous mesenchymal stem cells versus allogeneic mesenchymal stem cells in patients with chronic ischemic left ventricular dysfunction secondary to myocardial infraction. The precutaneous stem cell injection delivery effects on neomyogenesis Pilot study. I/II Darcy DiFede 305-243-9106 NCT01087996
Enrollment Complete Prometheus: A phase I/II, randomized, double-blinded, placebo-controlled study of the safety and efficacy of intramyocardial injection of autologous human mesenchymal stem cells (MSCs) in patients with chronic ischemic left ventricular dysfunction secondary to myocardial infraction (MI) undergoing cardiac surgery for coronary artery bypass grafting (CABG). I/II Darcy DiFede 305-243-9106 NCT00587990
Enrollment Complete TAC-HFT: A Phase I/II, Randomized, Double-Blinded, Placebo-Controlled Study of the Safety and Efficacy of Transendocardial Injection of Autologous Human Cells (Bone Marrow or Mesenchymal) in Patients With Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction.The Transendocardial Autologous Cells (hMSC or hBMC) in Ischemic Heart Failure Trial. I/II Darcy DiFede 305-243-9106 NCT00768066
Enrollment Complete TRIDENT: A phase II Randomized, Blinded Study of the Safety and Efficacy of Transendocardial Injection of Allogeneic Mesenchymal Stem Cells in Patients with Chronic Ischemic Left Ventricular Dysfunction Secondary to Myocardial Infarction. II Darcy DiFede 305-243-9106 NCT02013674
Not Yet Recruiting ACESO: A Phase I/II, Randomized, Pilot trial to evaluate the Safety and Efficacy of Allogeneic Mesenchymal Human Stem Cells infusion therapy for Endothelial DySfunctiOn in diabetic subjects. I/II Cindy Delgado 305-243-7444 or 305-243-1152 NCT02886884
Not Yet recruiting ANU: Allogeneic Human Mesenchymal Stem Cells (hMSCs) Infusion in Patients With Treatment Resistant Depression I Darcy DiFede 305-243-9106 NCT02675556
Not Yet Recruiting GALENE: A Phase I, Pilot Trial to evaluate the Safety and Efficacy of Injection of Allogeneic Mesenchymal Bone-Marrow Derived Human Stem Cells in Patients With Fistulizing Crohn’s Disease. I Diana Morillo (305) 243 – 6405 or (305) 243 – 8644 NCT02677350
Not Yet Recruiting Poseidon II: A Phase II, Randomized-Blind Study Testing the Efficacy of Transendocardial Injection of Allogeneic Mesenchymal Stem Cells in Patients With Chronic Ischemic Cardiomyopathy. II Darcy DiFede 305-243-9106 N/A
Not Yet Recruiting SIRONA: A Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety and Efficacy of Allogeneic Human Mesenchymal Stem Cells in Patients with Metabolic Syndrome 2b Cindy Delgado 305-243-7444 or 305-243-1152 NCT02587572
Not Yet Recruiting TAC-HFT II: Phase I/II Study of the Safety and Efficacy of Transendocardial Injection of Autologous Human Cells (Mesenchymal or the combination of MSC and Cardiac Stem Cells) in Patients with Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infraction. I/II Darcy DiFede 305-243-9106 NCT02503280
Multi-Center Clinical Trials
Enrollment Status Study Title Phase Contact CT.GOV identifier
Active, Enrolling CONCERT-HF: A Phase II, Randomized, Placebo-Controlled Study of the Safety, Feasibility, and Efficacy of Autologous Mesenchymal Stem Cells and c-kit+ Cardiac Stem Cells, Alone or in Combination, Administered Transendocardially in Subjects with Ischemic Heart Failure II Darcy DiFede 305-243-9106 or Cindy Delgado 305-243-7444 NCT02501811
Active, Enrolling SENECA: A Phase I, First-in-Human, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of the Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Cancer Survivors with Anthracycline-Induced Cardiomyopathy I Darcy DiFede 305-243-9106 or Cindy Delgado 305-243-7444 NCT02509156
Enrollment Complete PACE: Clinical and MR Imaging Assessments in Patients with Intermittent Claudication following Injection of Bone Marrow Derived ALDH Bright Cells. N/A Darcy DiFede 305-243-9106 NCT01774097
Active, Enrolling DREAM-HF: A Double-Blind, Randomized, Sham-Procedure-Controlled, Parallel-Group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (rexlemestrocel-L) in Patients With Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology. III Darcy DiFede 305-243-9106 or Cindy Delgado 305-243-7444 NCT02032004
Enrollment Complete Vericel: 55-1202-1: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of Transendocardial Injection of Ixmyelocel-T in Subjects with Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM) 2b Darcy DiFede 305-243-9106 NCT01670981
Enrollment Complete CELLADON: A Phase 2/3, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart Failure. 2b Darcy DiFede 305-243-9106 NCT02346422

For more information about our ISCI clinical trials, please contact our Research Office at 305-243-9106.