Autologous Cultured Myoblasts (BioWhittaker) Transplanted Via Myocardial Injection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00050765|
Recruitment Status : Unknown
Verified March 2006 by Bioheart, Inc..
Recruitment status was: Not yet recruiting
First Posted : December 19, 2002
Last Update Posted : March 8, 2006
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure Coronary Artery Disease Myocardial Infarction||Drug: MyoCell™ Autologous Myoblasts||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||15 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|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|
|Study Completion Date :||August 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050765
|Contact: Doug Owens, RN, BSN||(954) 835-1500 ext email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Warren Sherman, MD|
|United States, Georgia|
|Atlanta, Georgia, United States, 30342|
|United States, Illinois|
|Rush-Presbyterian-St. Luke's Medical Center|
|Chicago, Illinois, United States, 60612|
|Contact: Gary Schaer, MD FACC 312-942-4655 email@example.com|
|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|
|New York, New York, United States, 10029|
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|