Patients with congestive heart failure who have had a previous myocardial infarction.
Conditions
Interventions
Product Name: MyoCell
Pharmaceutical Form: Implant
Current Sponsor code: MyoCell
Other descriptive name: Autologous Skeletal Muscle Myoblasts
Sponsors
Bioheart, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (i) Defined region of myocardial dysfunction related to previous myocardial infarction (between 90 days and 3 years of screening) involving the anterior, lateral, posterior or inferior walls, assessed by the presence of a Q-wave on the ECG and a large area of akinesia in the left ventricle, confirmed by either left ventricular angiography or echocardiography; (ii) New York Heart Association (NYHA) Symptom Class II or III; (iii) Patients on optimal medical drug therapy for at least 2 months prior to study entry - defined as following the most current “ACC/AHA Guidelines for the Evaluation and Management of Chronic Heart Failure in the Adult” ; (iv) Age = 18 and = 75 years old; (v) Need or feasibility for re-vascularization has been ruled out by coronary angiogram or noninvasive stress testing within 30 days of screening, assessed using Dobutamine Stress Echocardiography; (vi) Able to undergo surgical biopsy of the skeletal muscle and successful culture of the harvested myoblasts; (vii) Well demarcated transmural myocardial scar, assessed by either MRI (delayed contrast enhanced scan) or echocardiography. Patients must have a minimum myocardial wall thickness of 5mm; (viii) Left ventricular ejection fraction at screening of : = 20% = 45% (by MUGA scan) for ICD patients = 20% = 45% (by MUGA scan) for non-ICD patients; (ix) Willing and able to give written informed consent; (x) If a female of childbearing potential, serum or urine pregnancy test must be negative within 2 weeks of study treatment; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (i) Myocardial infarction within 90 days or in excess of 3 years of the patient’s screening visit; (ii) New York Heart Association Symptom Class I or IV; (iii) Coronary Artery Bypass Grafting (CABG) within 6 months (180 days) prior to scheduled MyoCell™ implantation; (iv) Percutaneous Coronary Intervention (PCI) within 3 months (90 days) prior to scheduled MyoCell™ implantation; (v) Aortic valve replacement; (vi) Heart failure secondary to valvular disease; (vii) Left ventricular mural thrombus; (viii) Known sensitivity to gentamicin sulfate and/or amphotericin-B; (ix) Previous experimental angiogenic therapy and/or myocardial laser therapy; (x) Previous severe adverse reaction to nonionic radiocontrast agents; (xi) Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in any concurrent study that may confound the results of this study; (xii) Serum creatinine > 2.5 mg/dL or end stage renal disease; (xiii) Active infectious disease and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. If the panel includes antibodies to the HBV-cAg and HBV-sAg, then an expert will be consulted as to patient eligibility based on the patient’s infectious status; (xiv) Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study; (xv) 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; (xvi) Patients on chronic immunosuppressive transplant therapy; (xvii) ICDs implanted less than 6 months prior to cellular implantation procedure. ICD devices reprogrammed during the course of treatment and stable for less than 3 months. Patients fitted with a Bi-V pacer are excluded; (xviii) Patients who, in the opinion of the investigator, are not suitable to participate, following review of the catheter information given in the Instructions for Use - MyoCath Percutaneous MicroImplant Delivery System.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: There is a primary safety objective and a primary efficacy objective. The primary safety objective is that the MyoCell™ implant will be considered safe if the number of serious adverse events at 3 months and 6 months is less than that seen in the control group (receiving standard medical therapy), and falling within levels set in the statistical analysis plan. The primary efficacy objective is to demonstrate the response to MyoCell™ implantation on the change in LVEF at 3 and 6 months by MUGA compared to baseline. ; Secondary Objective: The secondary efficacy objective will be defined in the statistical analysis plan and will include but not be limited to: - Six Minute Walk (6MW) distance, NYHA classification, average Quality of Life (QOL) score, hospitalization, readmissions or the need for medical treatment outside of hospitalizations. - Contrast aided-Dobutamine Stress Echo (using non-ionic contrast) and Tissue Doppler Imaging for all patients to show improvements in: - Global and regional contractility - Wall thickness improvements - Coronary perfusion (ICD patients only) - Cardiac MRI for patients without an ICD to show improvements in: - Coronary perfusion - A further optional objective will be to assess any changes in infarct size seen after 3 and 6 months, compared to baseline. 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 ; Primary end point(s): Safety Endpoints (i) Defined Serious Adverse Events (SAE’s) and the comparison of these between the treatment arm and control arm. Pre-existing and concurrent illnesses will be defined and tabulated separately from cell therapy-related adverse events; (ii) R | — |
Countries
Belgium, United Kingdom
Outcome results
None listed