ISCT, JSRM launch 5-year collaboration on clinical iPSC therapies

The International Society for Cell & Gene Therapy (ISCT) and the Japanese Society for Regenerative Medicine (JSRM) announced a five-year strategic collaboration aimed at accelerating the clinical development of induced pluripotent stem cell (iPSC) therapies.

The partnership held its inaugural joint session in Kobe, Japan on March 21, 2026. It combines ISCT’s global network for developing translational standards in cell and gene therapy with JSRM’s expertise in iPSC-based regenerative medicine.

The initiative will focus on developing shared frameworks for quality control, potency assays, genomic stability monitoring, and tumorigenicity testing for iPSC-derived cell therapies. The groups also aim to support greater regulatory and manufacturing harmonization as the global clinical pipeline expands.

Japan has played a central role in the development of iPSC technology since Shinya Yamanaka’s Nobel Prize-winning discovery at Kyoto University’s Center for iPS Cell Research and Application (CiRA). Kobe, which hosted the collaboration’s inaugural meeting, is home to the RIKEN Center for Biosystems Dynamics Research, where the first transplant of iPSC-derived retinal pigment epithelium was performed in 2014.

Clinical development of iPSC-derived therapies is accelerating across indications including heart failure, spinal cord injury, macular degeneration, leukemia, and Parkinson’s disease. Most programs remain in Phase I trials. China currently hosts the largest number of active iPSC clinical studies, followed by Japan and the US.

No iPSC-derived therapy has yet received full marketing approval from a major regulator. Japan’s Pharmaceuticals and Medical Devices Agency has established conditional approval pathways for regenerative medicine products, providing a regulatory model other agencies are watching.

By coordinating working groups and joint publications, the ISCT–JSRM collaboration aims to develop global standards that could reduce regulatory and manufacturing barriers across the iPSC field.