Australia’s adult stem cell company, Mesoblast Limited has 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.
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.
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.
Over one million new patients with heart attacks are treated annually in the US alone, representing a multi-billion dollar market opportunity. Current therapies do not result in rebuilding of heart muscle, and do not prevent progression of congestive heart failure, poor quality of life, and long-term deterioration.