Alongside the Parkinson’s therapy, in March 2026 Japan approved a second product made from iPS cells: ReHeart, from Cuorips, a start-up born at Osaka University. It is intended for people with severe heart failure who no longer respond to conventional treatment.
What is ReHeart?
It consists of very thin sheets of heart muscle cells (cardiomyocytes) grown in the lab from donor iPS cells:
- Each sheet is 4 to 5 cm in diameter and just 0.1 mm thick.
- The sheets are placed on the surface of the heart during surgery.
- The goal is to support muscle repair and improve heart function.
Who is it for?
Patients with ischemic cardiomyopathy: heart muscle damage left by heart attacks or poor blood supply, once the usual treatment options have been exhausted.
What were the results?
In the clinical trial, 8 patients received the transplant and all showed fewer symptoms and better heart function, as reported. It is a small group, so these are early results.
What comes next?
As with the Parkinson’s therapy, this is a conditional, time-limited approval:
- Cuorips must collect more efficacy data over the next 7 years.
- The target is to treat and follow 75 patients with ischemic cardiomyopathy.
- With that information, the ministry will decide on full approval.
Why does it matter?
The heart has very little ability to regenerate on its own: muscle lost in a heart attack usually turns into scar tissue. Being able to add new heart muscle is one of the most ambitious goals of regenerative medicine, and ReHeart is the first approved product to attempt it with iPS cells.
With these two approvals, Japan became the first country to authorize iPS cell-based therapies, almost two decades after their discovery.
- The Medicine Maker. Japan Clears First iPSC Therapies for Clinical Use. March 2026.
- AABB News. Japanese Regulatory Panel Recommends Advancing World’s First iPSC-Based Therapies. February 24, 2026.
- South China Morning Post. Japan approves world’s first regenerative medicines using iPS cells. March 2026.
This content is for informational purposes only and does not replace evaluation by a health professional. It has not been evaluated by the FDA.
