A Phase II, Open-label, Randomized, Multicenter Study to Assess the Safety and Cardiovascular Effects of MyoCell™ Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction(s) - SEISMIC

Phase 1

• Conditions: Patients with congestive heart failure who have had a previous myocardial infarction.

• Registration Number: EUCTR2004-001922-26-GB
• Lead Sponsor: Bioheart, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 46

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

(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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified