hIPSC - useful links and further information

Knowledge Transfer

A key activity of the core facility is to provide a local hub for stem cell therapies in Cambridge but also to maintain a more extensive, external network of collaborators with complementary expertise in the clinical development of cell therapies. To achieve this the core facility has built working relationships with researchers in the field (both academic & commercial organisations), the Cell therapy Catapultand regulatory bodies. Members of the Core facility also regularly attend and present at conferences to keep this network current.

Useful Documents

The following is a list of documents that will help you understand some of the requirements, considerations and terminology used for clinical translation of stem cell therapies

o          Department for Business, Innovation and Skill (BIS) PAS 83: Developing human cells for clinical applications in the European Union and the United States of America (PDF)

o          MHRA Interim UK Regulatory Route Map for Stem Cell Research and Manufacture(PDF)

o          EMA Reflection paper on stem cell-based medicinal products (PDF)

o          EMA Guideline on human cell-based medicinal products (PDF)

o          EU Tissues and cells directive (3xPDF)

Technical Directive, Donation, Procurement and Testing

Technical Directive, Traceability

The following website from the Department of health is also a useful tool for those planning to conduct human stem cell research in the UK; allowing you to navigate your way through the regulations by responding to a series of key questions and building your own route map. http://www.sc-toolkit.ac.uk/home.cfmA

Useful Links

CTC – Cell Therapy Catapult

UKSCB – UK Stem Cell Bank

HFEA – Human Embryology and Fertilisation Authority

HTA – Human Tissue Authority

MHRA – Medicines and Healthcare products Regulatory Agency

EMA – European Medicines Agency