Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Bioheart, Inc. |
---|---|
Information provided by: | Bioheart, Inc. |
ClinicalTrials.gov Identifier: | NCT00050765 |
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.
Condition | Intervention | Phase |
---|---|---|
Congestive Heart Failure Coronary Artery Disease Myocardial Infarction |
Drug: MyoCell™ Autologous Myoblasts |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Factorial Assignment, Safety Study |
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 |
Estimated Enrollment: | 15 |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Doug Owens, RN, BSN | (954) 835-1500 ext 100 | dowens@bioheartinc.com |
United States, Florida | |
Bioheart, Inc | |
Ft. Lauderdale, Florida, United States, 33326 | |
United States, Georgia | |
ACRI | |
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 | |
Duke University | |
Durham, North Carolina, United States, 27705 |
Study ID Numbers: | Protocol BMI-US-01-001, Version F |
Study First Received: | December 18, 2002 |
Last Updated: | March 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00050765 |
Health Authority: | United States: Food and Drug Administration |
Myocardial Infarction Heart disease Coronary bypass graft (CABG) surgery Implantable Cardioverter Defibrillator (ICD) |
CABG ICD Heart failure |
Arterial Occlusive Diseases Coronary Disease Necrosis Heart Failure Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Infarction Myocardial Infarction Coronary Artery Disease |
Pathologic Processes Cardiovascular Diseases |