Austrialia's regenerative medicine company, Mesoblast Limited, announced successful early safety results in the world's first clinical trial to use allogeneic, or 'off-the-shelf', adult stem cells from an unrelated donor to treat patients with congestive heart failure.

Safety data from the first seven patients enrolled in the phase-2 trial by Mesoblast's Us-based sister company Angioblast System Inc. at medical centres in Arizona, California and Minnesota, were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington D C.

The trial is testing the safety and effectiveness of Revascor, the proprietary mesenchymal Precursor Cell (MPC) product injected by catheter into damaged heart muscle of patients with congestive heart failure.

No cell-related adverse events had occurred in any of the first patients implanted, Dr Nabil Dib, director of Cardiavascular Research, Chandler and Mercy Gilbert Medical Center, Arizona, and Associate Professor of Medicine, University of California at San Diego, reported to the conference.

Revascor is delivered to damaged areas of the heart by a minimally invasive cardiac catheterisation procedure performed under local anaesthesia while the patient is awake. Patients undergoing the procedure are released from the hospital within 24 hours.

The placebo-controlled trial will randomised up to 60 patients suffering from congestive heart failure, including those with non-ischemic cardiomyopathy, to either implantation with allogeneic adult stem cell or standard of care in a 3:1 ratio.

Dr Dib said, "We hope that these stem cells will increase the potential for myocardial repair and restoration of heart function. Revascor contains a well-characterised pure population of MPCs. These cells, obtained from a healthy young adult donor, are isolated, expanded and cultured to produce treatments potentially for thousands of patients."

According to company founder, Professor Silviu Itescu, "Heart failure remains a major cause of hospital admissions and patients deaths. Based on studies to date, Revascor has the potential to make a significant impact in patient with heart failure and to address this major clinical need.

"This phase-2 clinical trial is an important step toward our entry into this vital and growing market," Professor Itescu said.

Mesoblast Limited is committed to the development of novel treatments for orthopaedic conditions, including the rapid commercialisation of a unique adult stem cell technology aimed at the regeneration and repair of bone and cartilage.