Autologous Cultured Myoblasts (BioWhittaker) Transplanted Via Myocardial Injection
Recruitment status was: Not yet recruiting
Congestive Heart Failure
Coronary Artery Disease
Drug: MyoCell™ Autologous Myoblasts
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
|Study Start Date:||August 2006|
|Estimated Study Completion Date:||August 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050765
|United States, Florida|
|Ft. Lauderdale, Florida, United States, 33326|
|United States, Georgia|
|Atlanta, Georgia, United States, 30342|
|United States, Illinois|
|Rush-Presbyterian-St. Luke's Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, New York|
|Mt. Sinai Medical Center|
|New York, New York, United States, 10029|
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|