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World’s First Phase III Clinical Trial of Regenerative Medicine for Heart Failure
The world’s first phase III study of a regenerative medicine product targeting heart failure — the Congestive Heart FAilure Cardiopoietic Regenerative Therapy (CHART-1) trial — has been initiated in Europe. The study is investigating C3BS-CQR-1 (Cardio3 BioSciences), an autologous stem-cell product.
In the phase III prospective, multicenter, randomized, double-blind trial, C3BS-CQR-1 will be compared with sham treatment in a minimum of 240 patients with chronic advanced symptomatic heart failure. The study’s primary endpoint is a composite of mortality, morbidity, quality of life, the 6-minute walk test, and left ventricular structure and function at 9 months post-procedure.
C3BS-CQR-1 therapy involves taking stem cells from a patient’s bone marrow and “reprogramming” those cells through a process called cardiopoiesis so that the marrow cells can develop into new heart cells that behave identically to those lost to heart disease. These so-called cardiopoietic cells are then injected back into the patient’s heart through a minimally invasive procedure using a catheter, with the aim of repairing damaged tissue and improving heart function and patient clinical outcomes.
C3BS-CQR-1 is the result of years of research conducted at the Mayo Clinic in Rochester, Minnesota, and at clinical centers in Belgium. The new phase III trial builds on the results of a phase II study conducted in Europe in 2009 and 2010.
Source: Cardio3 BioSciences; November 22, 2012.