A double-blind, randomized, controlled, multicenter study to assess the safety and cardiovascular effects of skeletal myoblast implantation by catheter delivery in patients with chronic heart failure after myocardial infarction

Bioheart Inc. (USA)0 sites46 target enrollmentMarch 10, 2006

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Bioheart Inc. (USA)
Enrollment: 46
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2011 results in https://www.ncbi.nlm.nih.gov/pubmed/21982657 (added 28/01/2019)

Registry

who.int

Start Date

March 10, 2006

End Date

June 15, 2006

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Bioheart Inc. (USA)

Eligibility Criteria

Inclusion Criteria

•1\. Defined region of myocardial dysfunction related to previous myocardial infarction (most recent myocardial infarction must have occurred at least 90 days prior to muscle biopsy) involving the anterior, lateral, posterior or inferior walls, assessed by the presence of a Q\-wave on the electrocardiogram (ECG) and a large area of akinesia in the left ventricle, confirmed by either left ventricular angiography or echocardiography
•2\. New York Heart Association (NYHA) symptom class II or III
•3\. Patients on optimal medical drug therapy for at least two months prior to study entry \- defined as following the most current American College of Cardiology (ACC) or American Heart Association (AHA) guidelines for the evaluation and management of chronic heart failure in adults
•4\. Age \=18 and \=75 years old
•5\. Need or feasibility for re\-vascularization has been ruled out by coronary angiogram or non\-invasive stress testing within 30 days of screening, assessed using dobutamine stress echocardiography
•6\. Able to undergo surgical biopsy of the skeletal muscle and successful culture of the harvested myoblasts
•7\. Well demarcated transmural myocardial scar, assessed by echocardiography. Patients must have a minimum myocardial wall thickness of 5 mm.
•8\. Must have been fitted with an Implantable Cardioverter Defibrillator (ICD) in place for the duration of the study at least six months prior to muscle biopsy
•9\. Left ventricular ejection fraction at screening of \=20% \=45% (by multi\-acquisition gated \[MUGA] scan)
•10\. Willing and able to give written informed consent

Exclusion Criteria

•1\. Myocardial infarction within 90 days of the patient?s muscle biopsy
•2\. New York Heart Association Symptom Class I or IV
•3\. Coronary Artery Bypass Grafting (CABG) within six months (180 days) prior to scheduled MyoCell™ implantation
•4\. Percutaneous Coronary Intervention (PCI) within three months (90 days) prior to scheduled MyoCell™ implantation
•5\. Aortic valve replacement
•6\. Heart failure secondary to valvular disease
•7\. Left ventricular mural thrombus
•8\. Known sensitivity to gentamicin sulfate and/or amphotericin\-B
•9\. Previous experimental angiogenic therapy and/or myocardial laser therapy
•10\. Previous severe adverse reaction to non\-ionic radiocontrast agents