Adult Stem Cell Clinical Findings Presented at European Conference

Reuters, September 1, 2009

This week in Barcelona, at the 10th annual congress of the European Society of Cardiology, the U.S. company TCA Celluar Therapy is presenting its latest clinical findings on its own proprietary adult stem cell therapies in the treatment of two particular diseases, namely, critical limb ischemia (CLI) and refractory coronary ischemia (CI). TCA has already evaluated its therapies for both conditions in U.S. FDA-approved clinical trials.

According to Gabriel Lasala, M.D., president, co-founder and medical director of TCA, TCA is the only company in the world currently utilizing two different types of adult stem cells to treat both cardiac and vascular conditions. Most recently, Dr. Lasala and the company's scientific director, Dr. Jose Minguell, have together treated 33 patients for CLI in both Phase I and Phase II clinical trials in which patients were treated with a combination of autologous endothelial progenitor cells and mesenchymal stem cells harvested via bone marrow aspiration. The combined cells were then infused directly into areas of ischemic tissue and blood vessel damage, from which new, mature and stable vessels were observed to form via the natural angiogenic properties of these particular adult stem cells. No adverse side effects were observed in any of the patients, all of whom experienced "a progressive improvement in all clinical parameters which are still persisting a year after treatment," according to the researchers.

Similarly, in CI clinical trials, Drs. Lasala and Minguell completed a Phase I protocol last year and are currently conducting Phase II trials in which 60 patients have been enrolled. Thus far all patients have exhibited "a significant improvement in the quality of life", according to the doctors, with the results suggesting that "recruitment of new capillaries could be a leading event involved in the improvement of CI," as the researchers explain. According to Drs. Lasala and Minguell, this is the first safety and feasibility study that tests the infusion of this particular combination of adult stem cells.

As Dr. Lasala further describes, "All patients experienced improvement in their walking tests, ankle brachial pressure index, oxygen pressure, angiography and quality of life. The similarity in the recovery of our patients is promising. We find that the stem cells, once re-injected, go about forming new blood vessels, thus increasing circulation dramatically. These findings, coupled with increase of blood flow in collateral vessels, suggest that the therapy is both safe and effective."

Headquartered in Covington, Louisiana, TCA Cellular Therapy is currently participating in a number of FDA-approved clinical trials, all of which are testing novel adult stem cell therapies.