Heart Disease and Cellular Therapy: Start of Phase III Clinical Trial “PERFECT” Using Autologous CD133+ Bone Marrow Stem Cells

BERGISCH GLADBACH, Germany, October 29 /PRNewswire/ — 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 uweh@miltenyibiotec.de

http://www.miltenyibiotec.com

SOURCE Miltenyi Biotec GmbH