An Osaka University team said 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, a professor in the university’s cardiovascular surgery unit, and colleagues aim to transplant heart muscle cell sheets over the course of three years into 10 patients suffering from serious heart malfunction caused by ischemic cardiomyopathy.
As part of its first step in the project, the team conducted an operation on a patient this month, which was a success. The patient has since moved to the general ward at a hospital.
The cells on the degradable sheets attached to the surface of the patients’ hearts are expected to grow and 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.
Each sheet is around 4 to 5 centimeters wide and 0.1 millimeter thick.
The team will continue to monitor the patient over the next year.
“I hope that (the transplant) will become a medical technology that will save as many people as possible, as I’ve seen many lives that I couldn’t save,” Sawa said at a news conference.
The researchers said Monday they decided to conduct a clinical trial instead of a clinical study in hopes of obtaining approval from the health ministry for clinical applications as soon as possible.
The trial involves stringently evaluating risks, particularly cancer probabilities, and the efficacy of transplanting some 100 million cells per patient that may include tumor cells.
This is the second iPS cell-based clinical trial in Japan. The first was conducted on eye disease patients by the Riken research institute.