In Rostock very early the safety of intramyocardial stem cell therapy with bone marrow-derived CD133+ stem cells and evidence for a significant improvement of heart function has been shown (2001-2003: Phase I/II-clinical trial; 2003-2005: Phase II-clinical trial). Subsequently to these trials the worldwide first Phase III trial “PERFECT” was started on the initiative of the RTC in 2009. In all three trials autologous stem cells products have been intramyocardially applied in the frame of a bypass surgery to the patients who had a myocardial infarction .
For the conduct of the placebo-controlled multicentric trial PERFECT the RTC has been able to cooperate with several leading university Heart centers in Northern and Eastern Germany in a “Kompetenzliaison kardiale Stammzelltherapie” (Competence-liaison cardiac stem cell therapy): these are the Hannover Medical School, the German Heart Center Berlin, the University Heart Center Hamburg, the Heart Center Leipzig, the Heart and Diabetes Center Bad Oeynhausen, and the University Rostock Medical Center. Manufacturer of the investigational medicinal products as well as sponsor of the study according to GCP is the industry partner Miltenyi Biotec GmbH.
During the last year PERFECT has been subject to a coordinated governmental inspection at the study center of the RTC and at other clinical trial sites. Since no major issues were identified during these inspections the RTC obtained a “GCP- quality label”. In the course of 2014, a partially unblinded interim-analysis is planned from which data regarding the efficacy may be expected. The aim is to apply for the European approval subsequently to a positive completion of the trial and to establish a reference standard for future cardiovascular stem cell therapies.
On the trial PERFECT in the international study register www.clinicaltrials.gov
Study Protocol PERFECT Phase 3 Trial, ClinicalTrials.gov NCT00950274; Miltenyi Biotec GmbH Clinical Study Protocol PERFECT 001 (M-2006-144); EudraCT No.2006-006404-11
PERFECT trial partnership
Trial sites and R&D partners:
Clinic and Policlinic for Heart Surgery of Rostock
University Heart Center Hamburg
German Heart Institute Berlin (DHZB, Prof. R. Hetzer)
Hannover Medical School (MHH, Prof. A. Haverich)
University Heart Center Leipzig
Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen
Partner for biometric design and statistical analysis:
Institut für Medizinische Informatik und Biometrie
Miltenyi Biotec GmbH (Manufacturing and R&D)
Advanced Therapies Partners GmbH (ATP) (Consultant for clinical trial preparation and management)
Seracell Stammzelltechnologie GmbH (Manufacturer for the Investigational Medicinal Product)