To Assess Safety and Efficacy of Myoblast Implantation Into Myocardium Post Myocardial Infarction

Status unconfirmed · Phase 2/Phase 3

Conditions studied: Congestive Heart Failure

In brief

This study injects a person's own stem cells into heart muscle tissue after a person has one or more heart attacks. The purpose of the study is whether the stem cells will improve a patient's heart performance.

Key facts

Study ID

NCT00526253

Run by

Bioheart, Inc.

People needed

170

Starts

2007-09-01

Last updated by the study team

2017-07-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligible patients must meet ALL of the following inclusion criteria during the screening/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 the patient:
• 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 contemporary guidelines;
• 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 angiotensin receptor blockers (ARB);
• fluid control with diuretics and a salt restricted diet;
• patients with sever symptoms of heart failure (Class III-IV) lacking contraindications to aldosterone antagonism and not on both ACE inhibitors and ARBs have been considered for such therapy.
• Age 18-80;
• Left ventricular ejection fraction (LVEF) at screening of less than or equal to 35 percent by multiple gaited acquisition scan (MUGA);
• Need or feasibility for revascularization has been ruled out by previous coronary angiogram or ruled out to the satisfaction of the investigator via previous conventional stress study completed within 1 year of screening. The need or feasibility for revascularization will be reassessed at screening using dobutamine stress 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 basal septum) assessed by a large area of akinesia in the left ventricle (using DSE at screening);
• B-type natriuretic peptide (BNP) or NT pro-BNP is above the upper limit of normal.

You may not qualify if…

• Non-pregnant women who are not postmenopausal, surgically sterile or not practicing an acceptable method of contraception. A female patient of child bearing potential, with a positive serum or urine pregnancy test at screening visit #1. Females refusing to exercise a reliable form of contraception;
• Myocardial wall thickness of <6 mm (millimeters) in the akinetic myocardial region to be injected (using DSE at screening)
• Inability to undergo a surgical biopsy of the skeletal muscle for culture of myoblasts, 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 an implantable cardioverter defibrillator (ICD);
• Sustained ventricular tachycardia (VT), automatic implantable cardiodefibrillator (AICD) firing, or ventricular fibrillation (VF) within 90 days prior to screening visit #1;
• Inability to perform a 6 minute walk test due to physical limitations other than HF including:
• Severe peripheral vascular disease, including aortic aneurysms, leading to limited claudication;
• Severe pulmonary disease or chronic obstructive pulmonary disease (COPD) limiting exercise, dependence on chronic oral steroid therapy or previously requiring mechanical ventilation;
• Stroke or transient ischemic attack leading to limitations in lower extremities or occurring within 180 days prior to screening visit #1;
• MI, unstable angina or percutaneous coronary intervention (PCI) within 90 days prior to screening;
• having undergone CABG surgery within 150 days prior to screening visit #1;
• Active myocarditis, constrictive pericarditis, restrictive, hypertrophic or congenital cardiomyopathy;
• Hemodynamically significant severe primary valvular heart disease, unless corrected by a 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 as peripheral edema >+2 or rales ≥1/3 the lungs' height, need for intravenous therapy for HF within 60 days of screening visit #1 or hospitalization for HF within 90 days of screening 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 renal disease;
• Left ventricular mural thrombus;

Where it is running

• Cardiology, P.C. — Birmingham, Alabama, United States
• University of Alabama — Birmingham, Alabama, United States
• Mercy Gilbert Medical Center — Gilbert, Arizona, United States
• Arizona Heart Institute — Phoenix, Arizona, United States
• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Scripps Green Hospital — La Jolla, California, United States
• UCSD Medical Center — La Jolla, California, United States
• Jim Moran Heart and Vascular Research Institute — Fort Lauderdale, Florida, United States
• University of Florida — Gainesville, Florida, United States
• University of Florida Shands — Jacksonville, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Florida Hospital Center Cardiovascular Center — Orlando, Florida, United States
• Emory/Crawford Long — Atlanta, Georgia, United States
• St. Joseph's Research Institute/ACRI — Atlanta, Georgia, United States
• RUSH University Medical Center — Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• Our Lady of Lourdes Medical Center — Camden, New Jersey, United States
• Gagnon Heart Hospital — Morristown, New Jersey, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Lindner Center — Cincinnati, Ohio, United States
• University Hospital, Case Western Reserve University — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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