two patients from the results because of missing data. The studies are so small, the exclusion of those patients may have affected the results.
Hedrick says he’s pleased with the outcomes, which were being presented today at the 7th International Symposium on Stem Cell Therapy & Cardiovascular Innovation in Madrid. Based on the results, the company is preparing to test the cell therapy in a six-month-long European trial of 150-250 heart attack patients. The company hopes such a study will demonstrate the therapy can mitigate damage to the cardiac muscle and improve the flow of blood through the heart.
Hedrick says Cytori has the funds to conduct the trial.
In today’s studies, patients were treated with cells derived from their own belly fat. Cytori uses liposuction to remove the cells, and injects them in the patient’s coronary artery after processing them in its proprietary equipment at bedside. As we reported last year, the device is approved in Europe, where Cytori also is studying its use in breast reconstruction following partial mastectomy surgery. In the heart studies, Hedrick says the cellular mixture includes blood vessel cells and fat stem cells (which become blood vessel cells, according to Cytori) that help build new vessels to restore the damaged heart. The cellular mixture also contains growth factors that spur recovery.
Cytori is continuing to follow the heart patients. Hedrick says 12-month data on half the participants in the combined trials indicate the effects of the cell therapy persist.