Coronary Artery Disease Clinical Trial
Official title:
A Phase I Multi-Center Study to Assess the Safety and Cardiovascular Effects of MyoCell™ Implantation in Patients With a Previous MI and Placement of an ICD Requiring De Novo Coronary Artery Bypass Graft Therapy
MyoCell™ implantation by epicardial injection during CABG surgery has the potential to add a new dimension to the management of post-infarct deterioration of cardiac function. Based on existing non-clinical studies and clinical reports, implantation of autologous skeletal myoblasts appears to lead to the replacement of non-functioning myocardial scar with functioning muscle and appears to improve myocardial performance relative to case without myoblast implantation. In a few investigational patients, myoblast implantation can be, and has been, done in conjunction with CABG and appears to have the potential to provide for additive treatment during surgery. The present study is being conducted to evaluate more fully the safety of MyoCell™ implantation via epicardial injection during CABG surgery and its effect on regional myocardial function.
MyoCell™ mediated cellular cardiomyoplasty is a novel therapeutic approach to the management
of progressive heart failure in patients who have damaged myocardial tissue resulting from a
myocardial infarct. MyoCell™ consists of patient autologous skeletal myoblasts which are
expanded ex vivo and supplied as a cell suspension in a buffered salts solution for
injection into the area of damaged, akinetic myocardium with the goal of having the
myoblasts populate the implant area and generate elastic, contractile skeletal muscle-like
tissue within the damaged myocardium. Because the physiological goal is to replace
inelastic, fibrous myocardial scar tissue with skeletal muscle-like tissue, originating from
the cellular implants, this therapeutic approach is termed "cellular cardiomyoplasty" or
"CCM".
The purpose of this trial is to assess the safety of MyoCell™(expanded autologous skeletal
myoblasts) using a dose escalation methodology following epicardial injection into
myocardial scar tissue in patients who have experienced anterior, lateral, posterior or
inferior wall myocardial infarction, require coronary artery bypass graft (CABG) surgery and
who have an implantable cardioverter defibrillator (ICD) in place (ICD can be implanted
during the CABG procedure or 3 to 4 days post CABG procedure). Safety endpoints will be the
evaluation of the nature and frequency of Adverse Events during the 12-month period
following MyoCell™ treatment.
If a patient meets the baseline enrollment criteria, a 5-10 gram skeletal muscle biopsy will
be obtained for myoblast isolation and expansion in vitro at Bioheart's designated facility
for MyoCell™ production. Biopsy will occur 3 - 4 weeks prior to the anticipated implantation
of the MyoCell™ product. At the time of the patient's CABG surgery MyoCell™ will be injected
into the akinetic myocardial scar in the region of a previous infarct utilizing a sterile
hypodermic syringe fitted with a 25 gauge needle.
This will be a dose escalation study with 3 cohort groups consisting of 5 patients each. A
report of the 1 month safety data from each cohort will be presented to the data safety
monitoring board for permission to go to the next higher dosage. In the first cohort of this
dose escalation study; 2 injections will be performed, for the second cohort; 6 injections
and for the third cohort; 18 injections depending on the size of the infarct scar, so as to
inject the entire myocardial infarct scar akinetic area.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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