Trials Using Recombinant Vascular Growth Factor Protein Therapy

Different delivery modalities have been applied in clinical studies using recombinant growth factor therapies (Table 1). In most studies the growth factors have either been injected directly into the myocardium after a thoracotomy, into the coronary artery supplying the ischemic myocardium, administered intravenously systemically, or by a combination of these treatments [10-19]. The goal has been to reach a sufficient stimulation of the ischemic myocardium without any or minimal systemic side effects. 1. Recombinant fibroblast growth factor (FGF) protein therapy In the initial safety and efficacy studies recombinant FGF2 protein was delivered to the myocardium either as direct myocardial injections or as slow-release formulations in microcapsules during CABG in the tissue areas, where it was impossible to perform surgical revascularization (10-12) (Table 1). Schumacher et al. (10) investigated in a double-blind 1:1 placebo controlled design recombinant FGF2 protein treatment in 40 patients with three vessels disease. The patients all had both a proximal left anterior descending artery (LAD) stenosis, which could be bridged by an internal mammary artery graft (IMA) bypass and a distal LAD stenosis, which could not be revascularized. After bypass grafting of all treatable arteries, several injections were given intramyocardially,

Table 1. Treatment with recombinant vascular growth factor proteins for myocardial angiogenesis in chronic ischemic heart disease

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