An Osaka University team said Monday it has carried out the world's first transplant of cardiac muscle cells created from iPS cells in a physician-initiated clinical trial.

In the clinical project to verify the safety and efficacy of the therapy using induced pluripotent stem cells, Yoshiki Sawa, professor at the university's cardiovascular surgery unit, and colleagues aim to transplant heart muscle cell sheets into a total of 10 patients suffering from serious heart malfunction caused by ischemic cardiomyopathy.

The cells on the degradable sheets attached to the surface of the patients' hearts are expected to grow to secrete a protein that can regenerate blood vessels and improve cardiac function. The iPS cells have already been derived from healthy donors' blood cells and stored.

The researchers said they decided to conduct a clinical trial instead of clinical study to more stringently evaluate risks, particularly cancer possibilities, and efficacy of the transplant of some 100 million cells per patient that may include tumor cells, hoping to obtain approval of the health ministry for clinical application as soon as possible.

This is the second iPS cell-based clinical trial in Japan, after one on eye disease patients conducted, in a world first, by a group led by Riken, a government-affiliated research institute.

JIJI Press