Autologous Cultured Myoblasts (BioWhittaker) Transplanted Via Myocardial Injection
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
2 other identifiers
interventional
15
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2006
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2002
CompletedFirst Posted
Study publicly available on registry
December 19, 2002
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedMarch 8, 2006
March 1, 2006
December 18, 2002
March 6, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Defined region of myocardial dysfunction related to previous myocardial infarction involving the anterior, lateral, posterior or inferior walls, \> 12 weeks old at the scheduled time of MyoCell™ implantation procedure
- Patients must have an implantable cardioverter defibrillator (ICD) in place or, patients must receive ICD placement during the CABG procedure or 3 to 4 days after the CABG procedure
- Planned CABG procedure for revascularization
- Heart failure patient in New York Heart Association Symptom Class 2 or 3 who is on optimal medical therapy
- Age \> 18 and \< 80 years
- Able to undergo surgical biopsy of the skeletal muscle and successful culture of the harvested myoblasts
- Target region wall thickness \> 6 mm by echocardiography
- Left ventricular ejection fraction \> 20% and \< 40% by radionuclide ventriculography or left ventricular angiography at screening
- If a female of childbearing potential, urine pregnancy test must be negative
- Able to give written informed consent
You may not qualify if:
- Patient medically unable to undergo CABG surgery
- Any patient who has had a documented myocardial infarction (ECG changes or elevated cardiac enzymes consistent with MI) within 30 days of the scheduled surgical revascularization and cellular implantation procedure.
- Known sensitivity to gentamicin sulfate and/or amphotericin-B
- Exposure to any investigational drug or procedure within 4 weeks prior to study entry
- The use or expected use of antineoplastic drugs
- History of skeletal muscle disease, either primary (i.e., myopathy) or secondary (i.e., ischemic) or any underlying myopathy such as myasthenia gravis, muscular dystrophy, etc.) as determined by a board certified pathologist examining sample of patients muscle biopsy
- Previous angiogenic therapy and/or myocardial laser therapy
- History of cancer within 5 years, except for basal cell carcinoma of the skin
- PSA suggestive of carcinoma of the prostate (i.e., \> 4)
- Patient with CEA \>2.5 ng/mL or end stage renal disease
- Patients with active infectious disease and/or who are known to have tested positive for HIV, HTLV, HBV-sAg, HCV, CMV and/or syphilis. If the panel includes antibodies to the HBc and HBV-sAg, then an expert will be consulted.
- Females who are pregnant or nursing. Females of childbearing potential must be using to the investigator's satisfaction, a medically accepted method of birth control (e.g., but not limited to, oral or implanted contraceptive therapy or intrauterine devices) and agree to continue for the duration of the study.
- Any illness which might affect patient's survival over the study follow-up period
- Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.
- Patient with an any previous cardiac surgery
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bioheart, Inc.lead
Study Sites (5)
Bioheart, Inc
Fort Lauderdale, Florida, 33326, United States
ACRI
Atlanta, Georgia, 30342, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612, United States
Mt. Sinai Medical Center
New York, New York, 10029, United States
Duke University
Durham, North Carolina, 27705, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 18, 2002
First Posted
December 19, 2002
Study Start
August 1, 2006
Study Completion
August 1, 2006
Last Updated
March 8, 2006
Record last verified: 2006-03