Heart Disease and Cellular Therapy: Start of Phase III Clinical Trial "PERFECT" Using Autologous CD133+ Bone Marrow Stem Cells
BERGISCH GLADBACH, Germany, October 29 -- Miltenyi Biotec announces the treatment of the first patient in a phase III clinical trial termed PERFECT. The trial aims at determining whether intramyocardial injection of autologous CD133+ bone marrow stem cells improves heart function in addition to coronary artery bypass grafting (CABG) in patients with chronic ischemic heart disease and reduced pumping function.
PERFECT is a randomized, prospective, double-blind, placebo-controlled, multi-center trial, and it is the first phase III trial evaluating the efficacy of a cellular therapy product in cardiac disease. The trial is part of a large joint research project among the Heart Centers in Rostock, Berlin, and Hannover, which is supported by the German Federal Ministry of Education and Research. The first patient has been treated at the Heart Surgery Clinic in Rostock. A total of 142 patients will eventually be enrolled in the trial. All patients will have bone marrow aspirated from their iliac crest and will be randomized at a ratio of 1:1 to receive either CD133+ stem cells isolated from the bone marrow or a placebo injection. Improvement of heart function will be measured 6 months after the procedure. "Cellular therapy could be an important treatment option in patients suffering from a weak heart, and we are looking forward to the results of this investigation using CD133+ cells", states Professor Dr. Gustav Steinhoff, the leading principal investigator.
About Miltenyi Biotec
Miltenyi Biotec is a biotechnology company focused on the development of cellular therapies and biomedical research. The company is working with clinical investigators worldwide to develop cellular therapeutics for unmet medical needs and is committed to delivering the promise of cellular medicine in the fields of organ regeneration, immune modulation, and transplantation.
Contact Prof. Dr. Uwe Heinlein, Corporate Communications, Miltenyi Biotec GmbH Friedrich-Ebert-Str. 68, 51429 Bergisch Gladbach, Germany Phone +49-2204-8306-6590, e-mail firstname.lastname@example.org http://www.miltenyibiotec.com
SOURCE Miltenyi Biotec GmbH