Heart Failure Patients Successfully Implanted with Angioblast Systems’ “Off-the-Shelf” Adult Stem Cells
News Oct 20, 2008
Angioblast Systems Inc. announced successful initial safety results following commencement of the world’s first clinical trial to use allogeneic adult stem cells obtained from an unrelated, universal donor to treat patients with congestive heart failure.
The multi-center Phase 2 trial is examining the safety and effectiveness of three different doses of the company’s proprietary allogeneic, “off-the-shelf,” universal donor Mesenchymal Precursor Cells (MPCs) injected by catheter into damaged heart muscle of patients with congestive heart failure.
Safety data from the first seven patients enrolled in the trial by Angioblast at medical centers in Arizona, California, and Minnesota were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington D.C.
Dr. Nabil Dib, Director of Cardiovascular Research for Chandler Regional and Mercy Gilbert Medical Centers in Arizona, reported that no adverse events had occurred in any of the first seven patients following the catheter procedure.
The placebo-controlled trial of Angioblast’s Revascor™ MPC cell therapy will randomize up to 60 patients suffering from congestive heart failure, including those with non-ischemic cardiomyopathy, to either implantation with allogeneic adult stem cells or standard of care in a 3:1 ratio.
Angioblast’s Revascor™ adult stem cells are delivered to damaged areas of the heart by a minimally invasive cardiac catheterization procedure performed under local anesthesia while the patient is awake. Patients undergoing the procedure are released from the hospital within 24 hours.
Dr. Dib said: “We hope that the stem cells will increase the potential for myocardial repair and restoration of heart function. Angioblast’s Revascor™ cells are a well characterized, pure population of MPCs. These cells, obtained from a healthy young adult donor, are isolated, expanded and cultured to produce treatments potentially for thousands of patients.”
According to company founder, Professor Silviu Itescu, “Heart failure remains a major cause of hospital admissions and patient deaths. Based on studies to date, our Revascor™ MPCs have the potential to make a significant impact in patients with heart failure and to address this major clinical need.
“This Phase 2 clinical trial is an important step toward our entry into this vital and growing market,” Professor Itescu said.