The first group of patients to receive the lowest dose of Revascor, the proprietary "off-the-shelf" adult stem cell product for heart failure, have shown a sustained improvement in their heart muscle function after six months.
Mesoblast, an Australian company specialising in regenerative medicine, announced the interim results of the Phase-2 clinical trial being run in the US. The trial is being conducted by US-based Angioblast Systems, in which Mesoblast has a 34% holding.
The trial aims to compare one of three increasing doses of Revascor against standard of care in up to 60 patients suffering from moderate-severe congestive heart failure, defined as a baseline ejection fraction (EF) 40% or lower by echocardiogram.
Each dose is tested in a group of 20 patients, randomised 3:1 treated to control patients. 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 who received the lowest dose of Revascor received a single injection into damaged heart muscle. They were found to have significantly improved cardiac function at both three and six months compared with baseline.
At six months, a single dose of Revascor was accompanied by a 22% mean increase in EF, whereas controls had an 18% mean decrease in EF over the same time period. There were no cell-related adverse events.
The observed improvement between treated and controlled patients on top of medical standard of care was over two-fold higher than previously reported with existing device therapies.
So far, forty patients have been treated, with the final group of 20 patients evaluating the highest dose of Revascor expected to complete enrolment in early 2010.