We participated in the CONCERT-HF trial and the SENECA trials through the Cardiovascular Cell Therapy Research Network, a consortium of 7 centers in the US recognized for their expertise in stem cell research. The SENECA study was a Phase I trial that recruited 60 patients with heart failure after receiving chemotherapy for cancer. Unfortunately the chemotherapy, besides killing cancer cells, also kills heart muscle cells and at times patients survive their cancer but end up with heart failure. SENECA was designed to assess the effects of mesenchymal stem cells injected into the heart muscle of these patients. The study reached completion and the results show that the stem cells improved all 7 measures of heart function and plans are underway for a larger and more definitive Phase II trial.
The CONCERT-HF trial was designed to assess the ability of stem cells in improving heart function in patients with heart failure after a heart attack. In this study patients underwent a biopsy of their heart muscle and also a bone marrow aspiration. Both tissue samples were sent to the University of Miami where stems cells called c-kit positive cells were grown from the heart muscle and mesenchymal stem cells were grown from the bone marrow. Then the cells were sent back to the respective medical center the combination of c-kit and MSCs were injected into the heart muscle. This study has completed enrollment and all follow-up evaluations. We will be meeting in February to review the results of this exciting study.
We are collaborating with Meijing Wang,PhD in cardiothoracic surgery and using our 3D bioprinter to create scaffolds onto which heart cells can be implanted. His “beating” scaffold can then be used to surgically replace parts of the heart that have been damaged from a heart attack.
We are working with Phillip Yang, MD at Stanford University to develop new approaches to treating heart failure. Dr. Yang has shown that induced pluripotent heart muscle cells produce small microvesicles that contain mitochondria. Mitochondria are small organelles that are in every cell and they make ATP, which is the energy source for the cell to survive. When these microvesicles are injected into a pig heart with an infart they are able to rescue injured heart cells. We plan to create microbeads with the Buchi encapsulating device that will be loaded with mitochondria and Dr Yang will inject these into his pig model.
 Adenosine triphosphate (ATP), energy-carrying molecule found in the cells of all living things.