A Multicenter Study to Assess the Safety and Cardiovascular Effects of Myocell™ Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction(s)

Bioheart, Inc.33 sites in 1 country170 target enrollmentSeptember 2007

ConditionsCongestive Heart Failure

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Congestive Heart Failure
Sponsor: Bioheart, Inc.
Enrollment: 170
Locations: 33
Primary Endpoint: 6-minute walk test
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study injects a person's own stem cells into heart muscle tissue after a person has one or more heart attacks. The purpose of the study is whether the stem cells will improve a patient's heart performance.

Detailed Description

Autologous myoblasts are harvested from a patient's skeletal muscle tissue. The myoblasts are isolated and expanded in culture in a closed system. When a sufficient number of cells are estimated they are taken from culture, packaged in a suspension and sent to the patient's interventionalist. The interventionalist uses an injection catheter via femoral artery to inject the myoblasts directly into the myocardium.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

February 2019

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bioheart, Inc.

Eligibility Criteria

Inclusion Criteria

•Eligible patients must meet ALL of the following inclusion criteria during the screening/enrollment visit #1 and prior to being randomized into the study. Screening/enrollment visit #1 is defined to start the date the ICF is signed by the patient:
•Chronic CHF, New York Heart Association (NYHA) Class II-IV;
•Stable and on optimal medical management for greater or equal to 60 days as follows:
•systolic and diastolic hypertension controlled in accordance with contemporary guidelines;
•patient stabilized on maximum tolerated dose of beta blockers;
•patient stabilized on maximum tolerated dose of angiotensin concerting enzyme (ACE) inhibitors;
•patients intolerant of ACE inhibitors should be stabilized on angiotensin receptor blockers (ARB);
•fluid control with diuretics and a salt restricted diet;
•patients with sever symptoms of heart failure (Class III-IV) lacking contraindications to aldosterone antagonism and not on both ACE inhibitors and ARBs have been considered for such therapy.
•Left ventricular ejection fraction (LVEF) at screening of less than or equal to 35 percent by multiple gaited acquisition scan (MUGA);

Exclusion Criteria

•Non-pregnant women who are not postmenopausal, surgically sterile or not practicing an acceptable method of contraception. A female patient of child bearing potential, with a positive serum or urine pregnancy test at screening visit #
•Females refusing to exercise a reliable form of contraception;
•Myocardial wall thickness of \<6 mm (millimeters) in the akinetic myocardial region to be injected (using DSE at screening)
•Inability to undergo a surgical biopsy of the skeletal muscle for culture of myoblasts, including any significant myopathy;
•Patient will require revascularization within six months;
•Patients on continuous or intermittent intravenous drug therapy;
•Not fitted, or fitted within less than 90 days prior to screening visit #1, with an implantable cardioverter defibrillator (ICD);
•Sustained ventricular tachycardia (VT), automatic implantable cardiodefibrillator (AICD) firing, or ventricular fibrillation (VF) within 90 days prior to screening visit #1;
•Inability to perform a 6 minute walk test due to physical limitations other than HF including:
•Severe peripheral vascular disease, including aortic aneurysms, leading to limited claudication;