Before initiating the full randomized study, a Pilot Safety Phase will be performed. In this phase the composition of cells administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested. The randomized portion of the study will be conducted after a full review of the safety data from the pilot Phase by the Data safety monitoring board. Following the Pilot Phase of five (5) Fifty (50) patients scheduled to undergo cardiac catheterization and meeting all inclusion/exclusion criteria will be evaluated at baseline. Patients will be randomized in a 2:2:1 ratio to one of three Treatment Strategies.
A Phase I/II, Randomized, Placebo-Controlled 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 Infarction. A total of 55 subjects participating, with 5 in the pilot phase and 50 in the randomized phase. Patients with chronic ischemic left ventricular dysfunction and heart failure secondary to MI scheduled to undergo cardiac catheterization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Autologous hMSCs: 40 million cells/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 2 x 10\^8 (200 million) hMSCs.
Autologous hMSCs PLUS autologous C-Kit hCSCs: Mixture of 39.8 million hMSCs and 0.2 million C-Kit hCSCs/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 1.99 x 10\^8 (199 million) hMSCs and 1 million C-Kit hCSCs.
Placebo (ten 0.5 ml injections of phosphate-buffered saline \[PBS\] and 1% human serum albumin \[HSA\]).
ISCI / University of Miami
Miami, Florida, United States
Incidence of any treatment emergent serious adverse events (TE-SAEs)
Incidence (at one month post-catheterization) of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise), or atrial fibrillation.
Time frame: One Month post-catheterization
Treatment Emergent adverse event rates
Rate of adverse events occurring ad
Time frame: At 6 Month and 12 Month visit
Ectopic tissue formation
Ectopic tissue formation (as identified from MRI scans of the chest, abdomen, \& pelvis).
Time frame: At 6 Month and 12 Month visit
48-hour ambulatory electrocardiogram (ECG) recordings.
Electrocardiogram (ECG) recordings measured over 48 Hours
Time frame: At 6 Month and 12 Month visit
Hematology value changes post-catheterization
Hematology value changes will be observed at the 6 month and 12 month visit post-catheterization.
Time frame: At 6 Month and 12 Month visit
Urinalysis results changes post-catheterization
Urinalysis results changes will be observed at the 6 month and 12 month visit post-catheterization.
Time frame: At 6 Month and 12 Month visit
Clinical chemistry values post-catheterization
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Biosense Webster MyoStar NOGA Injection Catheter System will be used to administer the study drug
Clinical chemistry value changes will be observed at the 6 month and 12 month visit post-catheterization.
Time frame: At 6 Month and 12 Month visit
Pulmonary function
Pulmonary function - forced expiratory volume in 1 second (FEV1) results.
Time frame: At 6 Month and 12 Month visit
Serial troponin I values
Serial troponin I values (every 12 hours for first 48 hours post-cardiac catheterization).
Time frame: Every 12 hours for the first 48 hours post-cardiac catheterization
Creatine kinase-MB (CK-MB) value changes post-catheterization
CK-MB values (every 12 hours for first 48 hours post-cardiac catheterization).
Time frame: Every 12 hours for first 48 hours post-cardiac catheterization
Post-cardiac catheterization echocardiogram.
Echocardiogram performed after cardiac catheterization
Time frame: Day 1 Post Echocardiogram
Magnetic resonance imaging (MRI) measures of infarct scar size (ISS)
Document Infarct Scar Size (ISS) via Magnetic Resonance imaging (MRI)
Time frame: At 6 Month and 12 Month visit
Echocardiographic measures of infarct scar size (ISS)
Document Infarct Scar Size (ISS) via echocardiographic procedure
Time frame: At 6 Month and 12 Month visit
Magnetic resonance imaging (MRI) of Left Regional Ventricular Function
Document Left Regional Ventricular Function via Magnetic Resonance imaging (MRI)
Time frame: At 6 Month and 12 Month visit
Echocardiographic measures of Left Regional Ventricular Function
Document Left Regional Ventricular Function via echocardiographic procedure
Time frame: At 6 Month and 12 Month visit
Magnetic resonance imaging (MRI) of Global Ventricular Function
Document Global Ventricular Function via Magnetic Resonance imaging (MRI)
Time frame: At 6 Month and 12 Month visit
Echocardiographic measures of Global Ventricular Function
Document Global Ventricular Function via echocardiographic procedure
Time frame: At 6 Month and 12 Month visit
Tissue perfusion measured by MRI.
Measure Tissue Perfusion via Magnetic Resonance imaging (MRI)
Time frame: At 6 Month and 12 Month visit
Peak oxygen consumption (Peak VO2) (by treadmill determination).
Peak VO2 Oxygen Consumption determined by utilizing treadmill
Time frame: At 6 Month and 12 Month visit
Six-minute walk test.
Evaluate Functional Capacity via the Six Minute Walk Test
Time frame: At 6 Month and 12 Month visit
New York Heart Association (NYHA) functional class.
Evaluate Functional Capacity via New York Heart Association (NYHA) Class Determination
Time frame: At 6 Month and 12 Month visit
Minnesota Living with Heart Failure (MLHF) questionnaire.
Evaluate Quality Of Life Changes via Minnesota Living with Heart Failure (MLHF) Questionnaire
Time frame: At 6 Month and 12 Month visit
Incidence of Major Adverse Cardiac Events (MACE)
Incidence of Major Adverse Cardiac Events (MACE), defined as the composite incidence of (1) death, (2) hospitalization for worsening HF, or (3) non-fatal recurrent MI.
Time frame: At 6 Month and 12 Month visit