STAR-Heart Study Presented at the European Society of Cardiology


September 2, 2010

September 2, 2010 - The STAR-heart study, which was presented at the European Society of Cardiology 2010 Congress in August 2010, reported that the intracoronary injection of autologous stem cells derived from bone marrow is associated with improved hemodynamics and long term survival in the treatment of chronic heart failure.

Cardiogenesis Corporation released comments today regarding the STAR-heart study. The study involved 391 patients with chronic heart failure due to ischemic cardiomyopathy. Of these patients, 191 accepted the stem-cell treatment while the other 200, who did not agree to the intervention, acted as controls.

Paul McCormick Executive Chairman for Cardiogenesis said, "The positive results of the STAR-heart study reinforce our plan to initiate in the near future clinical studies in which autologous bone marrow cells will be used in conjunction with transmyocardial revascularization (TMR). Although our clinical studies testing delivery of stem cells with the PHOENIX Combination Delivery System will target different patient populations than the STAR study, the STAR study demonstrated the clinical benefit that can be derived from autologous bone marrow cells in patients with heart disease. The use of autologous bone marrow cells is akin to harnessing the combination of biologics that is naturally produced by the body as part of its regenerative process.

He added, "also relevant to our planned studies was the commentary by the STAR study investigators that pre-conditioning of the target myocardium was a key factor in the success of their implanted stem cells. Pre-conditioning in the STAR trial was accomplished by an ischemia-producing stimulus caused by balloon dilatation during the stem cell infusion, which seems to be important for creating an environment for the stem cells to home into the cardiac tissue and improve cell retention. In our clinical studies, PHOENIX will utilize its TMR System to create an environment to maximize cell retention by first treating the target myocardium with TMR, followed by cell injection. Our clinical studies follow on animal (pig) studies that demonstrated increased early cell survival in infarcted tissue when TMR was used as a pre-treatment to stem cell injection. We are optimistic that the combination of TMR plus concentrated bone marrow cells will have a synergistic effect in reducing angina in humans."

The company recently announced its plan to begin enrollment in a feasibility trial for the PHOENIX Combination Delivery System. The results of that ex-US study will be used in support of its FDA submission to begin a pivotal trial in the US.

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