Phase I Clinical Trial of Autologous Stem Cell-Sheet Transplantation Therapy for Treating Cardiomyopathy [Cardiovascular Surgery]

BackgroundWhen transplanted into failing heart, autologous somatic tissue–derived cells yield functional recovery via paracrine effects that enhance native regeneration. However, the therapeutic effects are modest. We developed a method in which scaffold‐free cell sheets are attached to the epicardial surface to maximize paracrine effects. This Phase I clinical trial tested whether transplanting autologous cell–sheets derived from skeletal muscle is feasible, safe, and effective for treating severe congestive heart failure.Methods and ResultsFifteen ischemic cardiomyopathy patients and 12 patients with dilated cardiomyopathy, who were in New York Heart Association functional class II or III and had been treated with the maximum medical and/or interventional therapies available, were enrolled. Scaffold‐free cell sheets of 3 to 9×108 cells derived from autologous muscle were transplanted over the LV free wall via left thoracotomy, without additional interventional treatments. There were no procedure‐related major complications during follow‐up. The majority of the ischemic cardiomyopathy patients showed marked symptomatic improvement in New York Heart Association classification (pre: 2.9±0.5 versus 6 months: 2.1±0.4, P

Source: JAHA:Journal of the American Heart Association - April 5, 2017 Category: Cardiology Authors: Miyagawa, S., Domae, K., Yoshikawa, Y., Fukushima, S., Nakamura, T., Saito, A., Sakata, Y., Hamada, S., Toda, K., Pak, K., Takeuchi, M., Sawa, Y. Tags: Cardiomyopathy, Cardiovascular Surgery Original Research Source Type: research