Mesoblast stem cell trial shows reduced heart failure risk
Thursday, 17 November, 2011
Mesoblast (ASX:MSB) has demonstrated that its adult stem cell therapy product Revascor can reduce the risk of heart failure.
Revascor is an over-the-counter treatment for cardiovascular conditions which is being jointly developed by Mesoblast and partner Israel-based Teva Pharmaceutical Industries.
Read more about Mesoblast and its stem cell therapy.
Patients in a phase II trial of the Mesenchymal Precursor Cell (MPC) treatment also showed no clinically significant signs of adverse immune responses to the donor cells.
The randomised, placebo controlled trial involved 60 patients with moderate to severe congestive heart failure. Of these, 45 patients received a single injection of Revascor, in either a high, medium or low dosage, and 15 were in a control group.
The test data indicates that the treatment can reduce the risk of a Major Adverse Cardiac Effect (MACE) by 78%.
Only one of the patients injected with Revascor died of cardiac causes during the trial, compared to three in the control group.
After 12 months, 40% of treated patients had been upgraded from class II or III New York Heart Association (NYHA) status to class I, compared to 14% of the control group.
At an 18-month follow-up, none of the 15 patients who had received the highest dose had either been hospitalised for heart failure or died, compared to three from the control group and six who had received a lower dose.
The largest dose was also associated with improved functional capacity and evidence of cardiac remodelling, but - unlike the lowest dose - not with improved ejection fraction.
The trial's independent principal investigator, Dr Emerson Perin, said this indicates that the positive effects of the large dose may be due to other mechanisms such as anti-fibrosis.
But according to Perin, who is medical director of the Stem Cell Center of the Texas Heart Institute, the results are a milestone in stem cell research for cardiac conditions.
“These clinical findings are the first using any cell therapy in heart failure patients to show a concordant positive effect on clinical outcomes, cardiac remodelling, and functional capacity - the three key parameters in congestive heart failure,” he said.
Mesoblast (ASX:MSB) shares fell 0.9% in relatively high volume trading on Wednesday, closing at $7.68.
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