Safety and Efficacy Hub
Translating regenerative medicine therapies safely into clinical practice
The Biotechnology and Biological Sciences Research Council (BBSRC), Engineering and Physical Science Research Council (EPSRC) and Medical Research Council (MRC) have established five interdisciplinary and complementary research Hubs as part of a £25M UK Regenerative Medicine Platform (UKRMP).
The emerging field of Regenerative Medicine Therapies (RMTs) has the potential to transform medicine to provide treatments and cures in areas of unmet need that are intractable to current practice. As with all emerging technologies, there are a number of barriers that need to be addressed, one of which is safety. The focus of the Safety Hub’s research programme is to provide a clearer understanding of the potential hazards (and associated risks) with RMTs, so that scientific stakeholders (academics, clinicians, pharmaceutical companies, biotechnology companies, regulatory authorities) are able to accelerate these new medicines into the human population with full confidence.
The Safety Hub consists of 4 collaborating Institutions: The University of Liverpool (lead Partner); The University of Manchester; University College London; and The University of Edinburgh. The hub brings together academics with expertise in the areas of Nanochemistry, Imaging, Biostatistics, Stem Cell Biology, Safety Science, Hepatology and Nephrology.
The main objectives of the Safety Hub are to:
- Identify emerging issues in the assessment of the safety of Regenerative Medicine Therapies.
- Develop and validate cell tracking agents to monitor the biodistribution of transplanted cells.
- Determine cell biodistribution in vivo to determine cell disposition over the short- and long-term and relate this to biological outcome.
- Determine safety and efficacy, identifying any Regenerative Medicine Therapies that cause toxicity.
The Safety Hub will provide a clear framework for the most appropriate label and imaging technology to use for robust safety assessment of RMTs. The benefits will be felt by those involved in the development of novel RMTs, ultimately leading to acceleration of these therapies into a clinical setting.
Read the University of Liverpool news story about the Hub.