San Diego-based Cytori Therapeutics (NASDAQ: [[ticker:CYTX]]) is announcing encouraging results this morning from two small, placebo-controlled studies of its fat-derived regenerative cell therapy in cardiac patients. The double-blind studies, which were conducted in Europe, should pave the way for a larger test in heart attack patients, the company says.
The first study involved 27 chronic heart disease patients; 18 got cell therapy and 9 received a placebo. After six months, the treatment group showed improvements on key measures of oxygen consumption and aerobic capacity. By contrast, the placebo group’s performance on those key measures declined. The differences between groups are statisically significant, the company says.
Specifically, the treated group showed an average 3.6 percent improvement in maximum oxygen consumption compared to an average 18.4 percent decline in the placebo group. Aerobic capacity in the treated group as measued by metabolic equivalents (METS) rose .2 points compared to a drop of .8 points in the placebo group.
The second study involved 14 heart attack patients; roughly two-thirds received cell therapy within 24 hours after arriving at the emergency room, the remaining patients were in a placebo group. Although the study was too small to demonstrate statistical validity, the treatment group showed a stronger improvement trend.
No serious side effects related to treatment were seen in trials, Cytori CEO Marc Hedrick tells me.
It’s important to note that each study excluded