On Monday, 27 January 2020, researchers from Osaka University in Japan have announced the first-ever successful physician-initiated clinical trial whereby heart muscles grown using induced pluripotent stem cells (iPSC) have been transplanted into a human patient.
Induced pluripotent stem cells – derived from the blood cells of healthy adult donors – were first reprogrammed back into their embryonic-like (pluripotent) state, then guided to mature into heart cells and were eventually placed on degradable sheets (each was 4-5 centimetres wide and 0.1 millimetre thick).
Ischaemic cardiomyopathy – the condition suffered by the subject of the pioneering procedure – usually requires a heart transplant if the case is particularly severe, yet the authors of the trial hope that the muscle cells on the sheet will secrete a protein which helps regenerate blood vessels, eventually leading to a marked improvement.
The surgery was performed earlier this month and the patient was since moved to the general ward of Osaka University’s hospital where he will be closely monitored for the rest of 2020 to make sure the procedure was effective and did not cause any unforeseen damage.
According to the research team led by Professor Yoshiki Sawa, the decision to conduct a clinical trial instead of a clinical study was made in order to increase the chances of convincing the national health ministry to approve clinical applications as soon as possible.
To achieve the above goal, the trial was designed to involve stringent evaluation of efficacy and risks, given that each participant will receive approximately 100 million cells, some of which may turn out to be malignant.
In addition to the patient who had already received a transplant, Sawa and colleagues plan to repeat the procedure on nine other people with the same condition within the upcoming three years.
If proven clinically, the procedure could actually replace heart transplants as sourcing iPSC is much easier than finding suitable heart donors and cardiac muscle grown in this manner is much more likely to be tolerated by the recipients’ immune systems.
“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 which took place in Suita, Osaka Prefecture in Japan.