A Research Study Investigating The Use Of CMV-Seronegative Haematopoetic Stem Cell Transplantation in Leukaemia

In this research study, haematopoetic stem cells are recovered from cytomegalovirus (CMV) negative donors and trausfused into CMV negative recipients suffering from leukaemia and following chemotherapy in an attempt to avoid the recipient developing CMV infection post-transplantation.

Because the research establishment will be procuring, storing and using human tissue, from which the stem cells will be isolated, a licence from the Human Tissue Authority (HTA) is required. In addition, Favourable Opinion from a Research Ethics Committee (REC) and approval from the local National Health Service Research and Development (NHS R&D) office are needed for the research to be conducted.

Because the stem cell treatment is a blood product which has not  been substantially manipulated, it is not a Medicinal Product or Investigational Medicinal Product, as defined by Medicines Legislation (See Glossary for definitions). This also means that the clinical research is not regulated under the Clinical Trials Regulations (see Glossary). Instead, the HTA oversee all quality and safety aspects of the study as set out in the Human Tissue (Quality and Safety for Human Application) Regulations 2007. In addition, all Serious Adverse Events (SAEs; See Glossary)) and Serious Adverse Reactions (SARs; See Glossary) that occur in the clinical research should be reported to the HTA.

The Gene Therapy Advisory Committee (GTAC) does not review the ethics of this clinical study because the cell therapy is not derived from a Stem C ell Line (see Glossary). Instead, Favourable Opinion from a REC is required, as is the approval of the local National Health Service Research and Development (NHS R&D) Office, but only if the research is to be conducted on NHS premises.

To see the Regulatory Route Map for this project, click on the route code M-96974. Alternatively, to see a Project View of the Regulatory Route, click on P-96974.