Funding by the Medical Research Council (MRC) Prosperity partnerships, the initiative leverages a unique collaboration between leading academic experts and industry leaders.
Advanced therapies, particularly those derived from human pluripotent stem cells (hPSCs), hold significant promise for treating a wide range of currently incurable diseases, from Parkinson's disease and macular degeneration to spinal cord injuries. These therapies take advantage of the unique ability of hPSCs to generate diverse, clinically relevant cell types. Clinical trials involving hPSC-derived cells are already underway globally, with many more on the horizon.
However, a potential problem to their widespread adoption has been the tendency for genetic changes in hPSCs during their production. Currently, identifying which of these genetic changes pose a genuine risk remains a challenge, and existing safety tests are often slow, costly, and may not accurately predict human responses.
This new project led by Professor Ivana Barbaric from the University of Sheffield and David Kuninger from ThermoFisher Scientific, is set to change this. Its aim is to mitigate these risks by developing reliable pre-clinical models for evaluating the safety of these therapies and finding new ways to minimise the occurrence of genetically altered cells during their development.
This pioneering partnership translates academic discoveries into practical, robust tools, fundamentally changing how we assess risk and ensuring that the life-changing advanced therapies reach patients faster and with the highest level of safety assurance.
Professor Ivana Barbaric
iSTAT begins in March 2026 uniting cross-disciplinary investigators from academia with substantial involvement and financial investment from industry leaders. Partners include Professor Nissim Benvenisty from the Hebrew University of Jerusalem, and industry group leaders from ThermoFisher Scientific, F. Hoffman-La Roche, STEMCELL Technologies, Roslin Cell Therapies, Smartcella Holding, The Centre for Commercialisation of Regenerative Medicine (CCRM), Rinri Therapeutics, BlueRock Therapeutics and Northern Health Science Alliance.
Dr Glenn Wells, MRC Deputy Executive Chair, said:
“This project is part of a £9 million public sector investment through MRC’s first Prosperity Partnerships. With matched funding from industry and close collaboration with key regulatory bodies, we are addressing the safety and toxicity of advanced therapies. This research is critical to improving how gene, cell-based, and nucleic acid-dependent therapies are developed for conditions such as cancers and rare genetic disorders, so we can make meaningful improvements to patient outcomes.”
This collaborative effort is a significant step forward in making advanced cell therapies safer, more accessible, and truly transformative for patients worldwide.