Phase
Condition
Heart Failure
Myocardial Ischemia
Coronary Artery Disease
Treatment
Hypothermosol
MyoCell
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Eligible patients must meet ALL of the following inclusion criteria during thescreening/enrollment visit #1 and prior to being randomized into the study.Screening/enrollment visit #1 is defined to start the date the ICF is signed by thepatient:
Chronic CHF, New York Heart Association (NYHA) Class II-IV;
Stable and on optimal medical management for greater or equal to 60 days as follows:
systolic and diastolic hypertension controlled in accordance with contemporaryguidelines;
patient stabilized on maximum tolerated dose of beta blockers;
patient stabilized on maximum tolerated dose of angiotensin concerting enzyme (ACE) inhibitors;
patients intolerant of ACE inhibitors should be stabilized on angiotensinreceptor blockers (ARB);
fluid control with diuretics and a salt restricted diet;
patients with sever symptoms of heart failure (Class III-IV) lackingcontraindications to aldosterone antagonism and not on both ACE inhibitors andARBs have been considered for such therapy.
Age 18-80;
Left ventricular ejection fraction (LVEF) at screening of less than or equal to 35percent by multiple gaited acquisition scan (MUGA);
Need or feasibility for revascularization has been ruled out by previous coronaryangiogram or ruled out to the satisfaction of the investigator via previousconventional stress study completed within 1 year of screening. The need orfeasibility for revascularization will be reassessed at screening using dobutaminestress echocardiography (DSE);
Defined region of mycardial dysfunction related to previous MI involving the anterior,later, posterior or inferior walls including the apical septum (excluding the basalseptum) assessed by a large area of akinesia in the left ventricle (using DSE atscreening);
B-type natriuretic peptide (BNP) or NT pro-BNP is above the upper limit of normal.
Exclusion
Exclusion Criteria:
Non-pregnant women who are not postmenopausal, surgically sterile or not practicing anacceptable method of contraception. A female patient of child bearing potential, witha positive serum or urine pregnancy test at screening visit #1. Females refusing toexercise a reliable form of contraception;
Myocardial wall thickness of <6 mm (millimeters) in the akinetic myocardial region tobe injected (using DSE at screening)
Inability to undergo a surgical biopsy of the skeletal muscle for culture ofmyoblasts, including any significant myopathy;
Patient will require revascularization within six months;
Patients on continuous or intermittent intravenous drug therapy;
Not fitted, or fitted within less than 90 days prior to screening visit #1, with animplantable cardioverter defibrillator (ICD);
Sustained ventricular tachycardia (VT), automatic implantable cardiodefibrillator (AICD) firing, or ventricular fibrillation (VF) within 90 days prior to screeningvisit #1;
Inability to perform a 6 minute walk test due to physical limitations other than HFincluding:
Severe peripheral vascular disease, including aortic aneurysms, leading tolimited claudication;
Severe pulmonary disease or chronic obstructive pulmonary disease (COPD) limitingexercise, dependence on chronic oral steroid therapy or previously requiringmechanical ventilation;
Stroke or transient ischemic attack leading to limitations in lower extremitiesor occurring within 180 days prior to screening visit #1;
MI, unstable angina or percutaneous coronary intervention (PCI) within 90 days priorto screening;
having undergone CABG surgery within 150 days prior to screening visit #1;
Active myocarditis, constrictive pericarditis, restrictive, hypertrophic or congenitalcardiomyopathy;
Hemodynamically significant severe primary valvular heart disease, unless corrected bya properly functional prosthetic valve;
Prior aortic valve replacement;
Systolic blood pressure (supine) ≤90 mmHg;
Resting heart rate >100 bpm;
Severe uncontrolled HF including any evidence of severe fluid overload such asperipheral edema >+2 or rales ≥1/3 the lungs' height, need for intravenous therapy forHF within 60 days of screening visit #1 or hospitalization for HF within 90 days ofscreening visit #1;
Patient scheduled to receive cardiac resynchronization therapy (CRT) during the study;
Expected to receive or received a cardiac transplant, surgical remodeling procedure,left ventricular assist device or cardiomyoplasty;
Six-minute walk test (6MWT) of >400 meters or Minnesota Living With Heart Failure (MLWHF) score of <20;
Hematocrit (HCT) concentration below 30% (males) or below 27% (females);
Serum creatinine greater than 2.5 mg/dL (milligrams per deciliter) or end stage renaldisease;
Left ventricular mural thrombus;
Known sensitivity to gentamicin sulfate; or severe adverse reaction to nonionicradiocontrast agents;
Active infectious disease and/or known to have tested positive for humanimmunodeficiency virus (HIV), human t lymphotrophic virus (HTLV), hepatitis B virus (HBV), hepatitis C virus (HCV), cytomegalovirus (CMV); immunoglobulin M [IgM], and/orsyphilis. If the panel includes antibodies to the HBV core antigen (HBV-cAg) andhepatitis B surface antigen (HBV-sAg), then an expert will be consulted as topatient's eligibility based on the patient's infectious status;
Patients have undergone enhanced external pulsation (EECP) tratment within the last 6months;
Exposure to any previous experimental angiogenic therapy and/or myocardial lasertherapy, or therapy with another investigational drug within 60 days of screeningvisit #1 or enrollment in any concurrent study that may confound the results of thisstudy;
Known drug or alcohol dependence or any other factors which will interfere with thestudy conduct or interpretation of the results or in the opinion of the investigatorare not suitable to participate;
Any illness other than CHF which might reduce life expectancy to less than 1 year fromscreening visit #1;
Recent initiation of cardiac resynchronization therapy via placement of abi-ventricular pacemaker or bi-ventricular AICD within 180 days of study enrollment;and
30 Unwilling and/or not able to give written informed consent.
Study Design
Study Description
Connect with a study center
Cardiology, P.C.
Birmingham, Alabama 35211
United StatesSite Not Available
University of Alabama
Birmingham, Alabama 35294
United StatesSite Not Available
Mercy Gilbert Medical Center
Gilbert, Arizona 85297
United StatesSite Not Available
Arizona Heart Institute
Phoenix, Arizona 85006
United StatesSite Not Available
Mayo Clinic Hospital
Phoenix, Arizona 85054
United StatesSite Not Available
Scripps Green Hospital
La Jolla, California 92037
United StatesSite Not Available
UCSD Medical Center
La Jolla, California 92103
United StatesSite Not Available
Jim Moran Heart and Vascular Research Institute
Fort Lauderdale, Florida 33317
United StatesSite Not Available
University of Florida
Gainesville, Florida 32610
United StatesSite Not Available
University of Florida Shands
Jacksonville, Florida 32209
United StatesSite Not Available
University of Miami Miller School of Medicine
Miami, Florida 33136
United StatesSite Not Available
Florida Hospital Center Cardiovascular Center
Orlando, Florida 32803
United StatesSite Not Available
Emory/Crawford Long
Atlanta, Georgia 30308
United StatesSite Not Available
St. Joseph's Research Institute/ACRI
Atlanta, Georgia 30342
United StatesSite Not Available
RUSH University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
Ochsner Medical Center
New Orleans, Louisiana 70121
United StatesSite Not Available
Minneapolis Heart Institute
Minneapolis, Minnesota 55407
United StatesSite Not Available
Our Lady of Lourdes Medical Center
Camden, New Jersey 08103
United StatesSite Not Available
Gagnon Heart Hospital
Morristown, New Jersey 07962
United StatesSite Not Available
Newark Beth Israel Medical Center
Newark, New Jersey 07112
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
The Lindner Center
Cincinnati, Ohio 45219
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
University Hospital, Case Western Reserve University
Cleveland, Ohio 44106
United StatesSite Not Available
The Ohio State University Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
University of Oklahoma
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Stern Cardiology
Germantown, Tennessee 38138
United StatesSite Not Available
Texas Heart Institute
Houston, Texas 77030
United StatesSite Not Available
Swedish Medical Center
Seattle, Washington 98122
United StatesSite Not Available
St. Luke's Medical Center
Milwaukee, Wisconsin 53215
United StatesSite Not Available
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