San Diego-based Cytori Therapeutics touted mid-stage results from a small trial of its experimental adult stem cell therapy for heart damage this morning. Researchers for the company zeroed in on three biomarkers for heart function, saying that they were able to divine statistically significant indicators that the stem cells improved the condition of patients who had either experienced a heart attack or were suffering from advanced coronary artery disease.
Only 27 patients were recruited for the European dose-escalating study. The group receiving the cell therapy demonstrated an improvement in the infarct size in the left ventricle while the control group reflected a worsening of their condition. There were also improvements in aerobic capacity and maximum oxygen consumption, or MVO2--indications of efficacy.
Cytori uses the Celution System to extract stem cells from a patient's fat tissue, enriches them and then infuses them back into the heart. While used in Europe for breast reconstruction and enhancement, the FDA earlier this year declined to allow its use in the U.S. until larger studies had demonstrated its utility. Based on that standard, Cytori still has a long way to go before it satisfies regulators.
Cytori faced some significant skepticism going into today's announcement. At TheStreet, Adam Feuerstein questioned whether the study had enrolled enough patients to actually demonstrate efficacy. And he cited bleeding complications that occurred for two subjects in a separate safety study. But Cytori stayed focused on the positive.
"We showed the Celution-based procedure is safe and feasible in severely compromised patients and improved various measures, which are suggestive of efficacy," said Dr. Emerson C. Perin, a co-principal investigator. "MVO2 in particular is one of the most widely accepted predictors of clinical outcomes, including mortality and the requirement for a heart transplant."
- here's Cytori's press release
- check out the story from TheStreet