Joseph C. Wu
This clinical study will utilize a new cell therapy approach (Human embryonic stem cells derived cardiomyocytes or hESC-CMs) to improve survival and cardiac function in patients with chronic left ventricular dysfunction secondary to MI (Myocardial Infarction).
The phase I dose-escalation pilot study is intended as an initial safety assessment to establish the MTD prior to the phase II randomized, double-blinded, placebo-controlled study. An estimated eighteen (18) patients in phase I who are scheduled to undergo cardiac catheterization and have met all inclusion/exclusion criteria will be enrolled.
Inclusion Criteria: * Be ≥ 21 and \< 80 years of age. * Provide written informed consent. * Have a diagnosis of chronic ischemic left ventricular dysfunction secondary to MI as defined by previous myocardial infarction documented by an imaging study demonstrating coronary artery disease with corresponding areas of akinesis, dyskinesis, or severe hypokinesis. * Be a candidate for cardiac catheterization within 5 to 10 weeks of screening. * Have been treated with appropriate maximal medical therapy for heart failure or postinfarction left ventricular dysfunction. For beta-blockade, the patient…
50 million (M) cells delivered in a dose of 5M cells per injection over 10 injections.
150M cells delivered in a dose of 15M cells per injection over 10 injections
300M cells delivered in a dose of 30M per injection over 10 injections
Arctuva estimate
Verify or correct the compensation shown for this listing.