Bhaskar
05-05-2007, 04:55 AM
FDA Clearance Received for Heart Attack Stem Cell Clinical Trial
Platform stem cell technology now in two major US-based trials
MELBOURNE, Australia, May 02, 2007 /PRNewswire- FirstCall/ -- Australia's adult stem cell company, Mesoblast Limited , today announced that the United States Food and Drug Administration (US FDA) has cleared the Investigational New Drug Submission (IND) of its US-based sister company, Angioblast Systems Inc., to commence a Phase 2 clinical trial of its allogeneic, or 'off-the-shelf' , adult stem cells for patients with heart attacks.
"FDA clearance is a significant step towards commercialising our stem cell products in the US, the world's largest market for cardiovascular diseases," said founder and Chief Scientific Adviser, Professor Silviu Itescu. "Importantly FDA clearance was obtained within 30 days of the submission of the IND," he said.
The Phase 2 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 IND submission. These 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. .......
More : http://www.pharmalive.com/News/index.cfm?articleid=437972&categoryid=21
Platform stem cell technology now in two major US-based trials
MELBOURNE, Australia, May 02, 2007 /PRNewswire- FirstCall/ -- Australia's adult stem cell company, Mesoblast Limited , today announced that the United States Food and Drug Administration (US FDA) has cleared the Investigational New Drug Submission (IND) of its US-based sister company, Angioblast Systems Inc., to commence a Phase 2 clinical trial of its allogeneic, or 'off-the-shelf' , adult stem cells for patients with heart attacks.
"FDA clearance is a significant step towards commercialising our stem cell products in the US, the world's largest market for cardiovascular diseases," said founder and Chief Scientific Adviser, Professor Silviu Itescu. "Importantly FDA clearance was obtained within 30 days of the submission of the IND," he said.
The Phase 2 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 IND submission. These 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. .......
More : http://www.pharmalive.com/News/index.cfm?articleid=437972&categoryid=21