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The Reference- and Translation Center for Cardiac Stem Cell Therapy (RTC) at Rostock University celebrated its one year anniversary in April 2010: time to look back on the first year and to give a future prospect.
The RTC is well on its way to develop new therapies with stem cells in the field of heart diseases. In October 2009 the clinical trial PERFECT has been started: a prospective, randomised double-blinded Phase III study. This multi-centric study aims to prove that injection of selected patient´s own bone-marrow stem cells during bypass surgery improves heart function, quality of life, and physical efficiency. The control group patients receive a placebo. More information about this trial is posted here.
In addition to the trial, the RTC coordinates research programs. Three working groups study the fundamental mechanism and safety of stem cell functioning in heart, and the standardization of the processes. More information about this program is posted here.
As a Reference- and Translation Center, the RTC manages the complex process starting from basic research over clinical development to the point of approval and application of stem cells as standardised and quality-checked therapies. The regenerative medicine (to which the stem cell therapy belongs) is still a very recent field of research. Thus, most of the therapies are still at the level of research or in early clinical development phases. The heart-surgical stem cell therapy developed at Rostock University is the first which is on its way to European-wide approval in the frame of the new legislation regarding Advanced Therapy Medicinal Products. Therefore the RTC team intensively studies the legal requirements and gathers experience in a novel field which will undoubtedly also be useful for follow-up studies.
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