Snapshot: FDA approves heart stem cell clinical trial for heart failure

Volume 10, Issue 1
Photograph of Dr. Andre Terzic explaining heart stem cells

Dr. Andre Terzic explains how heart stem cells were developed.

Photo of Christian Homsy, M.D., president of Cardio3, speaking at a news conference

Christian Homsy, M.D., president of Cardio3, shares his perspective on the heart stem cell clinical trial.

The Food and Drug Administration (FDA) has cleared the way for the Belgian company and Mayo Clinic collaborator Cardio3 BioSciences to launch a phase III clinical trial of its stem cell therapy based on Mayo Clinic regenerative medicine research.

The heart stem cell clinical trial will test the use of cardiopoietic (cardiogenically instructed) stem cells designed to improve heart health in people with heart failure.

These modified stem cells, which researchers describe as cardio-smart cells, have been produced according to the technique developed by Andre Terzic, M.D., Ph.D., director of the Mayo Clinic Center for Regenerative Medicine in Rochester, Minn., and his colleagues.

The multisite U.S. trial, called Chronic Heart Failure Analysis and Registry in the Tohoku District 2 (CHART-2 Study), hopes to recruit 240 patients with chronic advanced symptomatic heart failure.

Cardio3 BioSciences is a bioscience company based in Mont-Saint-Guibert, Belgium. Previous trials with the heart stem cells were held in Belgium, Serbia and Switzerland. A version of the phase III trial is now beginning in Europe.