What’s New?

4 December 2008

WARNING ON UNPROVEN
STEM CELL TREATMENTS

The Department of Health is aware of international, web-based schemes which purport to offer patients "stem cell treatments", "stem cell therapies" or participation in "stem cell trials". These claim to involve treatments for a variety of diseases, including Multiple Sclerosis, HIV infection, Parkinson's Disease and Cerebral Palsy. The schemes promise to treat UK patients overseas "for free." However, it is clear that there are, in fact, significant hidden costs and risks for potential patients. Some such schemes have already been shut-down by the local regulatory agencies, but others remain in operation. For patients who are considering involvement in such "stem cell trials", we strongly recommend that you:

1. Discuss participation in such schemes with your GP or Consultant.
2. Read "The Patient Handbook on Stem Cell Therapies" just issued by the International Society for Stem Cell Research (ISSCR). http://www.isscr.org/clinical_trans/pdfs/ISSCRPatientHandbook.pdf.
3. Check with the Department of Health whether a stem cell treatment has been approved by the appropriate regulatory agencies in the UK, by emailing any information to: gtac@dh.gsi.gov.uk.

Please also note that the MS Society has issued a statement on this issue: http://www.mssociety.org.uk/news_events/news/press_releases/ibs_stem_cells.html

October 2008

UKCRC Regulatory and Governance Advice Service

The UKCRC has established a UK-wide Regulatory and Governance (R&G) Advice Service which provides support for those involved in health research (including non-portfolio studies). The R&G Advice Service aims to provide consistent and authoritative advice on a range of regulatory and governance issues.

The R&G Advice Service does this by providing:
" Support for advice providers in NHS and University R&D offices; Medical Research Council employees; Topic-specific and Comprehensive Research Networks staff and Clinical Trial Unit staff without access to local R&D advice.
" A route for handling complex queries (via a web based application) e.g. those involving more than one regulatory issue.
" On-line resources such as Tool Kits, Question & Answers, Consultations, Best Practice guidance, Events and Training and R&G News.
The R&G Advice Service is supported by a network of regulatory and governance bodies (including GTAC), which prioritise queries to the Advice Service in order to provide authoritative and timely responses.

The service is jointly coordinated by the UKCRN R&G Team and the MRC Regulatory Support Centre (RSC).

Further information on the UKCRC R&G Advice Service can be obtained from the following website: www.ukcrc-rgadvice.org.uk.

May 2008

GTAC Now Oversees Both Stem Cell & Gene Therapies

From 1st May 2008, new amendments to the Clinical Trials Regulations have come into force. Included in these are revised arrangements for the way the Gene Therapy Advisory Committee (GTAC) operates. In future, GTAC will transfer gene therapy proposals to other Research Ethics Committees, if the proposal is deemed to be 'low genetic risk.'

This frees up GTAC to fulfil a change in its remit as a result of recommendation 8 of the UK Stem Cell Initiative ('The Pattison Report') to oversee the ethical conduct of stem cell clinical research. as well as gene therapy.