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news.Mesoblast's US subsidiary Angioblast Systems has been cleared by the FDA to commence a phase II clinical trial of its allogeneic, or 'off-the-shelf,' adult stem cells for patients with heart attacks.
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The phase II clinical trial will be based at the Texas Heart Institute, and will follow a similar protocol to the one used by the same investigators in preclinical studies for the investigational new drug (IND) submission. These studies showed that implantation of the company's proprietary allogeneic stem cells by catheter into damaged heart muscle resulted in significant improvement in heart function and reduction in congestive heart failure.
This clinical trial will be the first to test an allogeneic stem cell product injected by catheter into heart muscle damaged by a recent heart attack. The trial will use the latest generation catheters provided through Angioblast's ongoing relationship with the Johnson & Johnson companies Cordis Corporation and Biosense Webster.
The company's founder and chief scientific adviser, Professor Silviu Itescu, said: “FDA clearance is a significant step towards commercializing our stem cell products in the US, the world's largest market for cardiovascular diseases. Importantly FDA clearance was obtained within 30 days of the submission of the IND.”