Clinical Trials : A Large Scale Preservation 1 Trial Essay

838 Words Dec 5th, 2016 4 Pages
As noted above, alginate was the first biomaterial evaluated in clinical trials. IK-5001, an alginate hydrogel (1% sodium alginate plus 0.3% calcium gluconate) developed by Leor et al. and BioLineRX (Jerusalem, Israel) was shown to have therapeutic benefit in terms of reduced LV enlargement and increased scar thickness in a preclinical (porcine) infarction/reperfusion model in 2009 and soon entered a phase I clinical trial (NCT00557531) [9, 10]. In the first-in-man study, 27 patients with moderate-to-large ST-segment-elevation MI and successful revascularization were enrolled and had IK-5001 injected within 7 d after infarction through the infarct-related coronary artery using an infusion catheter with percutaneous radial artery access [11]. In the earlier porcine model, IK-5001 was shown to diffuse through the vasculature and gel in the infarcted myocardium [10]. Six months follow up showed the safety of the intracoronary hydrogel injection approach [11].
Following the phase I trial, a larger scale PRESERVATION-1 trial (NCT01226563) investigating the effectiveness of IK-5001 for prevention of ventricular remodeling and congestive heart failure was initiated [12-14]. The long-term results were recently reported with the conclusion that intracoronary injection of IK-5001 prevented neither LV remodeling compared to saline control nor the occurrence of heart failure [15]. 303 patients with large ST-elevation myocardial infarction (STEMI) were enrolled and randomized 2:1 to…

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