Ischemic cardiomyopathy (heart failure) Circulatory System Ischemic cardiomyopathy
Conditions
Interventions
Cell delivery via needle injection catheter versus standard medical therapy
Sponsors
Bioheart Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Defined region of myocardial dysfunction related to previous myocardial infarction (most recent myocardial infarction must have occurred at least 90 days prior to muscle biopsy) involving the anterior, lateral, posterior or inferior walls, assessed by the presence of a Q-wave on the electrocardiogram (ECG) and a large area of akinesia in the left ventricle, confirmed by either left ventricular angiography or echocardiography 2. New York Heart Association (NYHA) symptom class II or III 3. Patients on optimal medical drug therapy for at least two months prior to study entry - defined as following the most current American College of Cardiology (ACC) or American Heart Association (AHA) guidelines for the evaluation and management of chronic heart failure in adults 4. Age =18 and =75 years old 5. Need or feasibility for re-vascularization has been ruled out by coronary angiogram or non-invasive stress testing within 30 days of screening, assessed using dobutamine stress echocardiography 6. Able to undergo surgical biopsy of the skeletal muscle and successful culture of the harvested myoblasts 7. Well demarcated transmural myocardial scar, assessed by echocardiography. Patients must have a minimum myocardial wall thickness of 5 mm. 8. Must have been fitted with an Implantable Cardioverter Defibrillator (ICD) in place for the duration of the study at least six months prior to muscle biopsy 9. Left ventricular ejection fraction at screening of =20% =45% (by multi-acquisition gated [MUGA] scan) 10. Willing and able to give written informed consent 11. If a female of childbearing potential, serum or urine pregnancy test must be negative within two weeks of study treatment
Exclusion criteria
Exclusion criteria: 1. Myocardial infarction within 90 days of the patient?s muscle biopsy 2. New York Heart Association Symptom Class I or IV 3. Coronary Artery Bypass Grafting (CABG) within six months (180 days) prior to scheduled MyoCell™ implantation 4. Percutaneous Coronary Intervention (PCI) within three months (90 days) prior to scheduled MyoCell™ implantation 5. Aortic valve replacement 6. Heart failure secondary to valvular disease 7. Left ventricular mural thrombus 8. Known sensitivity to gentamicin sulfate and/or amphotericin-B 9. Previous experimental angiogenic therapy and/or myocardial laser therapy 10. Previous severe adverse reaction to non-ionic radiocontrast agents 11. Exposure to any investigational drug or procedure within one month prior to study entry or enrolled in any concurrent study that may confound the results of this study 12. Serum creatinine >2.5 mg/dl or end stage renal disease 13. Active infectious disease and/or known to have tested positive for Human Immunodeficiency Virus (HIV), Human T-cell Lymphotropic Virus (HTLV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Cytomegalovirus (CMV) (IgM > IgG) and/or syphilis. If the panel includes antibodies to the anti-hepatitis B virus core antigen (HBV-cAg) and anti-hepatitis B virus surface antigen (HBV-sAg), then an expert will be consulted as to patient eligibility based on the patient?s infectious status. 14. Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study 15. Any illness which might affect patient?s survival over the study follow-up period or any illness which, in the investigator?s judgment, will interfere with the patient?s ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results 16. Patients on chronic immunosuppressive transplant therapy 17. ICDs implanted less than six months prior to cellular implantation procedure. ICD devices reprogrammed during the course of treatment and stable for less than three months. Patients fitted with a Bi-V pacer are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety objective defined for this study is as follows: The MyoCell™ implant will be considered safe if the number of serious adverse events at three months and six months is less than that seen in the control group (receiving standard medical therapy), and falling within levels set in the statistical analysis plan. In addition, the number and mean length of stay for hospitalizations will also be captured. Primary MyoCell™ efficacy objective: The primary efficacy objective of SEISMIC is to demonstrate the response to MyoCell™ implantation on the change in Left Ventricular Systolic Function (LVEF) at three and six months by MUGA compared to baseline. Comparisons on LVEF will also be made between the two randomized groups (i.e. MyoCell™ implantation and standard medical therapy). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Objectives: The secondary efficacy objective will be defined in the statistical analysis plan and will include but not be limited to: 1. Six Minute Walk (6MW) distance, NYHA classification, average Quality of Life (QOL) score, hospitalization, readmissions or the need for medical treatment outside of hospitalizations 2. Contrast aided-dobutamine stress echo (using non-ionic contrast) and tissue doppler imaging for all patients to show improvements in: a. Global and regional contractility b. Wall thickness improvements c. Coronary perfusion d. A further optional objective will be to assess any changes in infarct size seen after three and six months, compared to baseline Secondary Safety Objectives: An additional safety objective will be to investigate the safety of the use of the MyoCath™, when used as a means of delivery of MyoCells™ for intracardiac implantation | — |
Countries
Belgium, Germany, Netherlands, Poland, Spain, United Kingdom
Outcome results
None listed