Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure Phase 2 Study Myoblast Autologous Grafting in Ischemic Cardiomyopathy (MAGIC) Study - MAGIC
- Conditions
- Ischemic Heart Failure
- Registration Number
- EUCTR2005-004034-41-DK
- Lead Sponsor
- Genzyme Europe B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Patients must meet the following criteria to be enrolled in this study:
1.Patient must be > = 18 and < = 80 years of age.
2.Patient must have a recommendation for a coronary bypass, preferably with cardiopulmonary bypass support. All patients meeting this criterion may be included, including those with target injection areas that may or may not be amenable to revascularization.
3.Patient must have an alteration in left ventricular function, defined as an ejection fraction (EF) of < = 35% and > = 15% (determined by echocardiography and confirmed by the core laboratory).
4.Patient must have significant myocardial dysfunction from a previous myocardial infarction demonstrated by the existence of akinesia affecting more than 2 accessible, contiguous left ventricular segments (out of 16) on a basal state echocardiogram, with no viability after stimulation with low dose dobutamine.
5.The left ventricular myocardial infarction (Q wave or positive enzyme) targeted for study injections must have occurred > = 4 weeks prior to screening.
6.Patient must qualify for insertion of an ICD device. Patient must have an ICD upon enrollment, receive an ICD before CABG surgery and study treatment or receive an ICD prior to discharge from the hospital following CABG surgery.
7.Patient should be a NYHA functional class I-III, who is receiving optimal contemporary medical management (e.g., ACE inhibitors, beta-blockers, diuretics, etc.). In Canada, only patients classified as NYHA Class II or III will be eligible for enrollment.
8.Fertile female patients with negative urine pregnancy test at screening and on the day of treatment prior to autologous skeletal myoblast administration.
9.Fertile female patients who have agreed to follow an approved method of contraception to avoid pregnancy for 60 days after receiving autologous skeletal myoblast administration (or longer if required by concomitant medication (e.g., amiodarone).
10.Patient must be committed to following the protocol requirements for 2 years as evidenced by written informed consent.
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
1.Need for a rapid surgical coronary revascularization (< = 21 days)
2.Need for any other related cardio-surgical measure during coronary surgery (e.g., mitral valve repair or valve replacement)
3.Patient with a left ventricular aneurysm who is a candidate for left ventricular aneurysmectomy or left ventricular reduction surgery
4.Patients receiving left or biventricular (BiV) pacing therapy for heart failure (unless the patient has stabilized after 6 or more months of this therapy)
5.Patient with cardiomyopathy presumed to be of non-ischemic origin (e.g., hypertrophic cardiomyopathy)
6.Patient for whom adequate echocardiography, or other required study procedures, cannot be performed for technical reasons
7.Patient for whom low dose of dobutamine, required for the identification of non-viable, scarred myocardium, is contra-indicated (e.g., recent sustained ventricular tachycardia and ventricular fibrillation)
8.Patient with advanced heart failure (e.g., NYHA IV heart failure symptoms, or in need of a heart transplant) who does not respond to optimal medical therapy and does not improve to at least Class III symptoms 30 days prior to skeletal muscle biopsy
9.Patient infected with the hepatitis C virus; the hepatitis B virus (HBs + antigen); patient who is HIV-1 or HIV-2 positive; HTLV-1 positive; Ag P24 positive (this exclusion criteria refers only to regions where this testing is required (e.g. France)
10.Patient with hemophilia; long-term immunosuppressive treatment, including with corticosteroids; stage III-IV arteriopathy of the lower limbs; significant muscular amyotrophia; peripheral muscular illness; serious intellectual deterioration or neuro-psychiatric disorders that would make follow-up difficult
11.Patient with allergies to gentamicin or other aminoglycosides, allergies to study required medications or imaging agents
12.Female patient who is pregnant, nursing, or fertile and using either no or an inadequate form of contraception
13.Illness other than ischemic heart failure that makes the short-range prognosis for survival questionable
14.Simultaneous participation in another study with an investigational study agent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method