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Study design

The ReGenHeart trial is a randomized, double-blinded, placebo-controlled multicentre phase II study which will be conducted at 6 centres in the EU. The study will evaluate the efficacy and safety of catheter mediated endocardial AdVEGF-D regenerative gene transfer in 180 patients with life-limiting angina pectoris or equivalent symptom despite optimal medical therapy and who are not suitable candidates for coronary revascularization with coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), refractory angina patients.

The patients will be selected for the trial on the basis of medical history, general status and coronary angiogram imaging, only those patients who are not eligible for coronary angioplasty or bypass operation (CCS class 2-3) due to diffuse coronary stenosis, small coronary vessels, repeated revascularisation or too high risk for the operation, will be included.

Patients will be randomised 2:1 to the treatment group and control group. Gene transfer will be performed by using the NOGA™ endocardial injection system. A dose of 1x1011 vpu of AdVEGF-D or matching placebo will be injected into 10 sites of the myocardium (0.2 ml per site). The placebo will be buffer solution with glycerol similar to that which the adenovirus is stored and delivered to the hospital in. The optimal injection site will be defined by using imaging of myocardial perfusion and from the electromechanical NOGA™ mapping system before the gene injection. First generation replication-deficient AdVEGF-D produced by Finvector Vision Therapies Oy, Finland, will be injected into ten sites in the endocardium.

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