The company plans to administer the treatments to patients within 24 hours of a heart attack. The stem cells will be injected into the heart through a catheter in the coronary artery. An earlier small study of only 14 patients was favorable and found that patients showed significantly less heart muscle damage following treatment compared to those who received standard treatment. Abnormal heart rhythm was also decreased.
So far, neither Europe nor the United States has approved any stem cell therapy for the heart, partly due to ethic concerns surrounding embryonic stem cells. We now know that stem cells can be extracted from fat as well as bone marrow and muscle tissue. Fat has pluripotent stem cells which can grow into any of the 200+ types of cells found in the human body, making fat stores an excellent source for effective stem cell harvesting.
The Celution One device allows for a fast extraction of the stem cells through a complex process by which the protective matrix around cells is broken down. Using differential centrifugation, the device separates out layers within a column, one of which are the stem cells. Those can be taken and used.
It's predicted that it will likely take at least 6 years for any regulatory approval of this treatment.