Cytori Heartened by Cell Therapy in Two Small Studies of Cardiac Patients

Xconomy San Diego — 

San Diego-based Cytori Therapeutics (NASDAQ: 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 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.

By posting a comment, you agree to our terms and conditions.

Comments are closed.