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

Last updated: July 20, 2017
Sponsor: Bioheart, Inc.
Overall Status: Trial Status Unknown

Phase

2/3

Condition

Heart Failure

Myocardial Ischemia

Coronary Artery Disease

Treatment

Hypothermosol

MyoCell

Clinical Study ID

NCT00526253
BMI-WW-02-003
  • Ages 18-80
  • All Genders

Study Summary

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.

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:

  1. Chronic CHF, New York Heart Association (NYHA) Class II-IV;

  2. Stable and on optimal medical management for greater or equal to 60 days as follows:

  3. systolic and diastolic hypertension controlled in accordance with contemporaryguidelines;

  4. patient stabilized on maximum tolerated dose of beta blockers;

  5. patient stabilized on maximum tolerated dose of angiotensin concerting enzyme (ACE) inhibitors;

  6. patients intolerant of ACE inhibitors should be stabilized on angiotensinreceptor blockers (ARB);

  7. fluid control with diuretics and a salt restricted diet;

  8. 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.

  9. Age 18-80;

  10. Left ventricular ejection fraction (LVEF) at screening of less than or equal to 35percent by multiple gaited acquisition scan (MUGA);

  11. 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);

  12. 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);

  13. B-type natriuretic peptide (BNP) or NT pro-BNP is above the upper limit of normal.

Exclusion

Exclusion Criteria:

  1. 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;

  2. Myocardial wall thickness of <6 mm (millimeters) in the akinetic myocardial region tobe injected (using DSE at screening)

  3. Inability to undergo a surgical biopsy of the skeletal muscle for culture ofmyoblasts, including any significant myopathy;

  4. Patient will require revascularization within six months;

  5. Patients on continuous or intermittent intravenous drug therapy;

  6. Not fitted, or fitted within less than 90 days prior to screening visit #1, with animplantable cardioverter defibrillator (ICD);

  7. Sustained ventricular tachycardia (VT), automatic implantable cardiodefibrillator (AICD) firing, or ventricular fibrillation (VF) within 90 days prior to screeningvisit #1;

  8. Inability to perform a 6 minute walk test due to physical limitations other than HFincluding:

  9. Severe peripheral vascular disease, including aortic aneurysms, leading tolimited claudication;

  10. Severe pulmonary disease or chronic obstructive pulmonary disease (COPD) limitingexercise, dependence on chronic oral steroid therapy or previously requiringmechanical ventilation;

  11. Stroke or transient ischemic attack leading to limitations in lower extremitiesor occurring within 180 days prior to screening visit #1;

  12. MI, unstable angina or percutaneous coronary intervention (PCI) within 90 days priorto screening;

  13. having undergone CABG surgery within 150 days prior to screening visit #1;

  14. Active myocarditis, constrictive pericarditis, restrictive, hypertrophic or congenitalcardiomyopathy;

  15. Hemodynamically significant severe primary valvular heart disease, unless corrected bya properly functional prosthetic valve;

  16. Prior aortic valve replacement;

  17. Systolic blood pressure (supine) ≤90 mmHg;

  18. Resting heart rate >100 bpm;

  19. 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;

  20. Patient scheduled to receive cardiac resynchronization therapy (CRT) during the study;

  21. Expected to receive or received a cardiac transplant, surgical remodeling procedure,left ventricular assist device or cardiomyoplasty;

  22. Six-minute walk test (6MWT) of >400 meters or Minnesota Living With Heart Failure (MLWHF) score of <20;

  23. Hematocrit (HCT) concentration below 30% (males) or below 27% (females);

  24. Serum creatinine greater than 2.5 mg/dL (milligrams per deciliter) or end stage renaldisease;

  25. Left ventricular mural thrombus;

  26. Known sensitivity to gentamicin sulfate; or severe adverse reaction to nonionicradiocontrast agents;

  27. 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;

  28. Patients have undergone enhanced external pulsation (EECP) tratment within the last 6months;

  29. 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;

  30. 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;

  31. Any illness other than CHF which might reduce life expectancy to less than 1 year fromscreening visit #1;

  32. 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

Total Participants: 170
Treatment Group(s): 2
Primary Treatment: Hypothermosol
Phase: 2/3
Study Start date:
September 01, 2007
Estimated Completion Date:

Study Description

Autologous myoblasts are harvested from a patient's skeletal muscle tissue. The myoblasts are isolated and expanded in culture in a closed system. When a sufficient number of cells are estimated they are taken from culture, packaged in a suspension and sent to the patient's interventionalist. The interventionalist uses an injection catheter via femoral artery to inject the myoblasts directly into the myocardium.

Connect with a study center

  • Cardiology, P.C.

    Birmingham, Alabama 35211
    United States

    Site Not Available

  • University of Alabama

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Mercy Gilbert Medical Center

    Gilbert, Arizona 85297
    United States

    Site Not Available

  • Arizona Heart Institute

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Mayo Clinic Hospital

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Scripps Green Hospital

    La Jolla, California 92037
    United States

    Site Not Available

  • UCSD Medical Center

    La Jolla, California 92103
    United States

    Site Not Available

  • Jim Moran Heart and Vascular Research Institute

    Fort Lauderdale, Florida 33317
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • University of Florida Shands

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • University of Miami Miller School of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

  • Florida Hospital Center Cardiovascular Center

    Orlando, Florida 32803
    United States

    Site Not Available

  • Emory/Crawford Long

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • St. Joseph's Research Institute/ACRI

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • RUSH University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Ochsner Medical Center

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Minneapolis Heart Institute

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Our Lady of Lourdes Medical Center

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Gagnon Heart Hospital

    Morristown, New Jersey 07962
    United States

    Site Not Available

  • Newark Beth Israel Medical Center

    Newark, New Jersey 07112
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • The Lindner Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University Hospital, Case Western Reserve University

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The Ohio State University Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Stern Cardiology

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Texas Heart Institute

    Houston, Texas 77030
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Site Not Available

  • St. Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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