CV-201

Principal Investigator: Craig Selzman
Keywords: Stem Cell , Heart Failure , Ischemic Cardiomyopathy Department: Cardiothoracic Division
IRB Number: 00078953 Co Investigator:  
Specialty: Cardiology, Cardiology, Cardiothoracic Surgery, Cardiothoracic Surgery, Cardiology
Sub Specialties: Heart Failure, Heart Stem Cell Therapy, Heart Failure, Adult Congenital Heart Disease
Recruitment Status: Recruiting

Contact Information

Carlyn Sander
carlyn.sander@hsc.utah.edu
8015875727

Brief Summary

Primary Objective: To investigate the safety and feasibility of endomyocardial injection of VentriGel via the intra ventricular approach at early and late time points following myocardial infarction.

Secondary Objective: To investigate the preliminary efficacy of VentriGel by measuring the changes from baseline to three and six months post procedure of scar size, scar mass and viable mass, left ventricular dimensions and volumes, ejection fraction, cardiac index, regional wall motion scores, serum BNP concentration, exercise tolerance testing, quality of life assessment, New York Heart Association (NYHA) Functional Classification assessment, hospital cardiac readmissions and MACE data.

Inclusion Criteria

  1. The subject is 30-75 years of age

  2. The subject must be able to provide informed consent

  3. At least 60 days and no more than 3 years will have passed since the first ST elevation

    myocardial infarction (Index STEMI) at time of VentriGel administration

  4. The Index STEMI must meet the following criteria:

    1. First time diagnosis of STEMI AND;

    2. Meet the STEMI criteria of the American College of Cardiology (ACC)/American

      Heart Association (AHA) (e.g. ST elevation in at least 2 contiguous leads >0.2 mV in V1, V2 or V3 and/or >0.1mV in at least two other leads), or new left bundle branch block (LBBB)

  5. Evidence of left ventricular remodeling secondary to myocardial infarction using 2-D echocardiography:

    1. the LVEF must be ≥ 25% and ≤ 45% AND;

    2. The left ventricular wall thickness is ≥ 8 mm in target area

  1. Successful percutaneous coronary intervention (PCI) restoring TIMI II of higher flow to infarcted area

  2. Negative pregnancy test [serum human chorionic gonadotropin (βhCG)] in women of childbearing potential within 24 hours prior to dosing) or if less than 2 years postmenopausal agree to use of adequate contraception during the study

  3. Must be ambulatory, willing and able to comply with protocol, including follow-up visits

  4. Subject must be receiving best medical treatment for their post-MI clinical presentation according to the American College of Cardiology (ACC)/American Heart Association

    (AHA) guidelines

  5. For those subjects indicated for heart failure medical therapy, subjects must be on stable

    therapy including beta-blockers and angiotensin converting enzyme inhibitors, if tolerated, for at least 45 days prior to therapy delivery

Exclusion Criteria

  1. Contraindications to cardiac MR

  2. NYHA Functional Classification Class 4 heart failure within the prior 6 months.

  3. Significant coronary artery stenosis that may require percutaneous or surgical

    revascularization within six months of enrollment, as determined by the principal

    investigator

  4. Left ventricular thrombus, left ventricular aneurysm, and subjects with post-infarction

    pericarditis.

  5. Frequent, recurrent, sustained (>30 seconds) ventricular tachycardia in 30 days prior to

    VentriGel administration

  6. ECG or 24 hour Holter Monitor with any of the following findings:

o Bifascicular block (left bundle branch block or right bundle branch block plus left hemi-block)

o Higher grade AV block (i.e. 3rd degree)

o Ventricular tachycardia (>= 5 seconds of VT OR any symptomatic VT)

  1. Atrial fibrillation with heart rate greater than 110 bpm.

  2. Severe valvular disease (e.g. aortic stenosis of moderate or worse severity, valvular

    insufficiency requiring surgical repair) or history of heart valve replacement.

  3. Known allergy to porcine proteins or prior implantation of a porcine derived medical

    product including cardiac valves or other ECM products.

  4. Etiology of heart failure due to any cause (e.g. hypertrophic cardiomyopathies, restrictive

    cardiomyopathies, constrictive pericardial disease, amyloidosis, active myocarditis,

    primary valve disease) other than ischemic cardiomyopathy.

  5. Severe peripheral vascular disease that impairs femoral arterial access.

  6. Less than 3 years, cancer free, since end of treatment for cancer (with exception of basal

    cell carcinoma).

  7. Alcohol or drug dependency within six months prior to enrollment

  8. Cerebrovascular event within the 90 days prior or major surgical procedure or major

    trauma within the 14 days prior to enrollment.

  1. Participation, defined as receiving test article, in an experimental clinical study within 30 days prior to administration of VentriGel (i.e. screen failure from other study does not exclude subject).

  2. Uncontrolled hypertension defined as systolic blood pressure (SBP) > 180 mmHg and/or or diastolic blood pressure (DBP) >110 mmHg.

  3. Abnormal laboratory values as defined below performed at screening:

o Aspartate aminotransferase [AST]/ alanine aminotransferase [ALT] ≥ 3 times

upper limit of normal (ULN)
o Serum creatinine ≥ 2.0 mg/dL
o Platelet count < 50,000/mm3
o Hemoglobin < 9.0 g/dL
o HbA1c > 9.0%
o PT or aPTT with clinically significant elevations relative to local laboratory

norms

  1. Any other cardiac or non-cardiac conditions or illness which, in the opinion of the

    principal investigator, may place subjects at undue risk or compromise the objectives of

    the study.

  2. Institutional interpretation of cMR EF data outside the ≥ 25% and ≤ 45% limits.