An Open-Label Study to Evaluate the Safety of SDF-1 Gene Therapy Administered by Endomyocardial Injection to Patients with Ischemic Heart Failure

The purpose of this study is to determine the safety and  efficacy of a recombinant DNA gene therapy administered using an experimental cardiac direct-injection catheter for patients with heart failure/cardiomyopathy. Four sites nationwide expect to enroll 16 participants. At Rush University Medical Center, we expect to recruit approximately four patients. The treatment will be open label; there is no placebo treatment.

You may be eligible for this study if you:

• Have NYHA Class III heart failure
• Have ischemic cardiomyopathy
• Area 18 years of age or older
• Have an ejection fraction of 40 percent or less
• Have an implanted, functional AICD

You are not eligible for this study if you:

• Have a history of cancer within the last five years
• Have atrial fibrillation
• Have an AICD recently implanted within 3 months
• Have had a prior organ transplant
• Have a history of liver or kidney disease
• Have aortic stenosis or an artificial aortic valve

This is a partial list of eligibility and exclusion criteria. To inquire whether you are eligible for this study, please call the contact number provided. If you choose to inquire via e-mail, please refer to the study title in your correspondence.