hIPSC - Clinical Development

To realise and retain local potential by translating laboratory science into clinically relevant therapies; meeting unmet clinical needs and increasing patient access to cell therapies; establishing Cambridge as a centre of excellence

Introduction

One area of great promise for the application of pluripotent stem cells, particularly IPSC, is in cellular therapy. However, the clinical development of any medicinal product can be extremely challenging, particularly in a nascent field of medicine, such as stem cell therapy, where the routes to clinic are not well trodden. Therefore a keyobjective of the hIPSC Core Facility is to support use of IPSCs in novel clinical applications by providing regulatory expertise in pre-clinical / clinical trial development, GMP processes and access to the GMP clean rooms at Cambridge University Hospitals NHS Foundation Trust (Adddenbrookes hospital). The core facility can provide advice, consultation, managerial and/or practical support for cell based therapy projects.

Therefore, even in its earliest stage, if your stem cell research will or might potentially have clinical application(s)please contact us to see how we can assist you

Early hIPSC how we can help (including but not limited to)

  • Discuss the suitability of your project to clinical translation.
  • Advise what routes to clinic are open to you.
  • Advise, assist or indeed practicallysupport the process of translating laboratory methods to cGMP compatible processes.
  • Advise and/or manage preclinical or clinical testing of your therapy
  • Help build your relationships with the appropriate regulatory authorities (HFEA, HTA, MHRA etc.) or interact with them on your behalf. Including document & submission preparation.
  • Assist / collaborate on funding applications to support the clinical translation process. Including introduction to organisations such as the Cell Therapy Catapult (CTC)

Early hIPSC Core facility involvement

The Core Facility can get involved no matter what stage your research is at. However, by discussing your projects early with Core facility there are many potential advantages. Such as building “Quality by Design” into your research to minimise the need to any repeatfindings during clinical development, which will ultimately save both time & resources.