Autologous Cultured Myoblasts (BioWhittaker) Transplanted Via Myocardial Injection

Status unconfirmed · Phase 1

Conditions studied: Congestive Heart Failure, Coronary Artery Disease, Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT00050765

Run by

Bioheart, Inc.

People needed

15

Starts

2006-08-01

Expected to finish

2006-08-01

Last updated by the study team

2006-03-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• Patient with valvular disease greater than mild in degree which is considered the primary cause of their heart failure
• Patient in New York Heart Association Symptom Class 1 or 4
• Patient with serum creatinine > 2.5
• No informed consent or unable to provide informed consent

Where it is running

• Bioheart, Inc — Fort Lauderdale, Florida, United States
• ACRI — Atlanta, Georgia, United States
• Rush-Presbyterian-St. Luke's Medical Center — Chicago, Illinois, United States
• Mt. Sinai Medical Center — New York, New York, United States
• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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