Autologous Cultured Myoblasts (BioWhittaker) Transplanted Via Myocardial Injection
Recruitment status was Not yet recruiting
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.
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
|Contact: Doug Owens, RN, BSN||(954) 835-1500 ext firstname.lastname@example.org|
|United States, Florida|
|Ft. Lauderdale, Florida, United States, 33326|
|Contact: Richard Spencer, JD, MBA (954) 835-1500 RSpencer@bioheartinc.com|
|Contact: Doug Owends, RN, BSN, CCRA (954) 835-1500 email@example.com|
|Principal Investigator: Warren Sherman, MD|
|United States, Georgia|
|ACRI||Not yet recruiting|
|Atlanta, Georgia, United States, 30342|
|United States, Illinois|
|Rush-Presbyterian-St. Luke's Medical Center||Not yet recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Gary Schaer, MD FACC 312-942-4655 firstname.lastname@example.org|
|Contact: Carrie Schlaffer, BS, CCRC (312) 942-8901 Carrie_Schlaffer@rush.edu|
|Principal Investigator: Gary L Schaer, MD FACC|
|Sub-Investigator: Robert March, MD|
|United States, New York|
|Mt. Sinai Medical Center||Not yet recruiting|
|New York, New York, United States, 10029|
|United States, North Carolina|
|Duke University||Not yet recruiting|
|Durham, North Carolina, United States, 27705|