Biologic ventricular assist tissue (BioVAT) is formulated from engineered heart muscle composed of cardiomyocytes and stromal cells derived from allogeneic induced pluripotent stem cells for cardia...

In a first-of-its-kind human trial, researchers transplanted iPS-cell-derived dopaminergic progenitors into patients with Parkinson’s disease and observed promising motor improvements with no serious ...

Korea establishes first clinical-grade iPSC bank to boost cell therapy R&D

Regenerative medicines are headed for people with Parkinson’s disease or severe heart failure — but researchers are concerned about minimal clinical-trial data.

The 5th iPSC Drug Development Summit is the longest-standing and most comprehensive meeting focused exclusively on iPSC-derived therapies

FT819 is currently being evaluated in a multicenter phase 1 clinical trial.

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Kenai Therapeutics, a clinical-stage biotechnology company pioneering next generation approaches to cure neurological conditions, today announced the completion of enrollment for the REPLACE™ Phase…

Japan's Ministry of Health, Labor and Welfare has granted conditional approval to two innovative regenerative medicine products derived from induced pluripotent stem (iPS) cells, marking the world's first authorizations of their kind. Announced on March 6, 2026, this milestone coincides with the 20th anniversary of Shinya Yamanaka's pioneering creation of mouse iPS cells at Kyoto University. iPS cells are reprogrammed adult cells that can differentiate into any cell type, offering immense potential for regenerative medicine without the ethical issues of embryonic stem cells. The first approved product is ReHeart by Qualipse, consisting of cardiomyocyte sheets grown from donor iPS cells. Intended for patients with severe heart failure from ischemic cardiomyopathy, the treatment involves attaching three cell sheets to the heart surface during surgery. These cells secrete signaling proteins that enhance blood flow and promote tissue repair. Early clinical data from a multicenter study showed promising improvements in peak oxygen consumption for some patients. The second product, Amusepri (laguneprocell) developed by Sumitomo Pharma and Racthera, features progenitor cells that develop into dopamine-producing neurons. Aimed at Parkinson's disease patients unresponsive to standard drugs like levodopa, it is implanted directly into the brain through small skull holes using minimally invasive techniques. Physician-led trials at Kyoto University demonstrated motor symptom improvements and confirmed cell viability at the transplant site. Manufacturing will occur at SMaRT, the world's first commercial facility for donor iPS cell-derived therapies in Osaka Prefecture. The iPS cells originate from Kyoto University's stock, supported by extensive industry-academia collaborations. These conditional approvals require ongoing post-marketing studies for safety and efficacy verification, a Japanese regulatory feature that accelerates access in complex fields like regenerative medicine. This development highlights Japan's integrated ecosystem, from basic research to production and policy support. While treatments will initially be limited and insurance coverage is pending, experts view this as the start of broader applications for iPS technology in medicine. Yamanaka and other researchers emphasize proceeding with scientific caution to ensure long-term success.