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The RTC has started this placebo-controlled, prospective and randomised double-blind clinical Phase III study in 2009. This study aims to provide proof of quality, efficacy, and safety of the cardiac stem cell therapy which is developed at Rostock. Three study centers are participating in PERFECT involving the Clinic and Policlinic for Cardiac Surgery of Rostock, the German Heart Institute Berlin and the Hannover Medical School. 142 participating patients are involved in this study. They have to conform to the requirement of a bypass surgery after a myocardial infarction.
Base on random, these patients were divided in two groups, i.e., the control group and the treatment group. The patients of the control group will get sera (placebo) while the patients of the treatment group will receive their own bone-marrow-derived stem cells. For that purpose, a defined cell fraction – CD133+ stem cells – will be isolated from the bone-marrow-derived cells of the patients. This cell fraction will be purified and finally suspended in patients´own sera.
During the bypass surgery the patients will be intramyocardially injected with their own purified bone-marrow-derived stem cells and only sera, respectively. To monitor the treatment efficacy the left ventricular ejection fraction (LVEF) will be measured by means of magnetic resonance tomography (MRT, primary clinical end-points).
The study aims to provide evidence of additional positive functional effects when patients are treated with autologous bone-marrow-derived CD133+ stem cells during a bypass surgery as compared to a bypass surgery without stem cell treatment. Furthermore it aims to prove that injection with CD133+ stem cells does not cause any damaging side effects but improves the patients´ physical fitness, heart function, and life quality.
Phase III Study PERFECT at  www.clinicaltrials.gov
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