The information requested is not held centrally.

The Department has provided £19 million in additional funding to improve the provision of stem cells through the work of our delivery partners, NHS Blood and Transplant and Anthony Nolan since 2011. This funding has supported a range of developments including the targeted recruitment of young male donors. To date over 75,000 young male donors have been recruited and evidence shows that these donors are approximately six times more likely to be requested to donate.

The total number of registered donors on the Anthony Nolan and NHS Stem Cell Registry continues to expand. In 2010 the total number of registered United Kingdom donors was 770,000 but by the end of 2014 was in excess of one million. Investment by the Department has supported our delivery partners NHS Blood and Transplant and the charity Anthony Nolan to recruit a cohort of young male donors that are approximately six times more likely to be able to donate. Over 19,000 additional donors are planned to be recruited in the current financial year.

Quality is a key issue for the clinical usefulness of cord blood samples. The collection of cord blood is arranged to maximise the proportion of samples with the highest quality. The number of banked cord samples of clinical grade continues to increase with in excess of 15,000 now banked.

International cooperation is an essential element of the provision of stem cells to patients requiring a transplant. Worldwide, 50% of adult stem cell donations and 30% of cord blood donations move across national boundaries.

The Government is committed to ensuring that the provision stem cells through the Department’s delivery partners, NHS Blood and Transplant and the Anthony Nolan, is as effective as possible and this includes adopting innovative practice to maximise the chance that donors will be able to donate.

The ethnic diversity of the United Kingdom is reflected in adult bone marrow donors through the targeted recruitment of donors. The diverse nature of the UK stem cell resources means that they will play an important part of the global network matching donors to patients. The information supplied from the UK unified registry (Anthony Nolan and NHS Stem Cell Registry) to the global registry (Bone Marrow Donors Worldwide) directly increases the chances that patients across the globe have a chance to find a suitable donor.

Since 2012, the Department has provided nearly £19 million to improve the provision of stem cells in the United Kingdom for all people. This funding has enabled the recruitment of over 75,000 young male donors who are more likely to be able to donate bone marrow and we continue to expand the pool of young male donors.

The stem cell improvement programme has directly addressed the difficulty faced by patients from the Black, Asian and Minority Ethnic (BAME) community and those with mixed ethnicity through targeted recruitment. The Department also continues to support the work of the National BAME Transplant Alliance. The programme has also funded the collection of umbilical cord blood samples, which has a specific target to achieve 40% of samples come from BAME and mixed ethnicity births.

The sponsors of the trials have included the following information in the European Union clinical trials register concerning the sites involved in the studies.

1. Systemic amyloidosis

2. Multiple myeloma

Funders of myeloma treatment trials and studies hosted by the National Institute for Health Research (NIHR) clinical research infrastructure include the following organisations:

- All Ireland Co-operative Oncology Research Group;

- Array Biopharma Inc.;

- Bristol Myers Squibb;

- Cancer Research UK;

- Celgene;

- Cell Medica Ltd;

- Centocor Ortho Biotech Services, Inc.;

- Chiron Corporation;

- Chugai Pharma UK;

- Eli Lilly;

- F. Hoffmann-La Roche Ltd;

- Genmab;

- Insightec;

- International Myeloma Foundation;

- Janssen Cilag International NV;

- Kay Kendall Leukaemia Fund;

- Kyowa Hakko Kirin Pharma, Inc;

- Leukaemia and Lymphoma Research;

- Medical Research Council;

- Merck & Co., Inc.;

- Millennium Pharmaceuticals, Inc.;

- MPD Voice;

- Myeloma UK;

- NIHR;

- Novartis

- Onyx Therapeutics, Inc.;

- Schering Health Care Ltd; and

- Wellcome Trust.

The following NIHR biomedical research centres are hosting myeloma treatment trials and studies:

- Cambridge University Hospitals NHS Foundation Trust, in partnership with the University of Cambridge;

- Guy’s and St Thomas NHS Foundation Trust, in partnership with King’s College London;

- Oxford University Hospitals NHS Trust, in partnership with the University of Oxford;

- Royal Marsden NHS Foundation Trust, in partnership with the Institute of Cancer Research; and

- University College London Hospitals NHS Foundation Trust, in partnership with University College London.

The following National Health Service trusts receiving NIHR funding for clinical research facilities for experimental medicine are hosting myeloma treatment trials and studies:

- Brighton and Sussex University Hospitals NHS Trust;

- Cambridge University Hospitals NHS Foundation Trust;

- Central Manchester University Hospitals NHS Foundation Trust;

- The Christie NHS Foundation Trust;

- University Hospital Southampton NHS Foundation Trust; and

- University Hospitals Birmingham NHS Foundation Trust.

Over 100 sites in the NHS are recruiting patients to one or more myeloma trials and studies hosted by the NIHR Clinical Research Network.

The Department of Health is a member of the National Cancer Research Institute (NCRI). NCRI Clinical Studies Groups (CSGs) bring together clinicians, scientists, statisticians and lay representatives to coordinate development of a strategic portfolio of trials within their field. All CSGs interact with clinical research networks, funders (including NIHR) and researchers to develop studies aimed at improving outcomes for patients. The Haematological Oncology CSG has a Myeloma Subgroup and its 2013-14 annual report is available on the NCRI website at:

http://csg.ncri.org.uk/wp-content/uploads/2014/11/NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf

All designated NIHR infrastructure for experimental medicine is contractually required to report annually on progress with agreed research work plans.

The trial opened to patient recruitment in July 2012 and the planned close date is 30 November 2015. Current United Kingdom recruitment is 640 and the planned target is 800. A maximum of 110 trial sites are being sought. The National Institute for Health Research (NIHR) Clinical Research Network Co-ordinating Centre has provided the following list of 89 UK sites currently open to recruitment.

Seven Phase 2 or 3 trials for systemic amyloidosis and 58 Phase 2 or 3 trials for multiple myeloma have been approved in the United Kingdom since 2004. Four trials for systemic amyloidosis and 41 trials for multiple myeloma are currently still ongoing.

The National Institute for Health Research (NIHR) Clinical Research Network is currently setting up a study that will aim to image amyloid deposition in systemic amyloidosis using hybrid positron emission tomography/magnetic resonance imaging, with the future potential to diagnose and monitor treatment response in this condition.

The NIHR Health Technology Assessment programme is funding a £1.9 million trial assessing the benefit of antibiotic prophylaxis and its effect on healthcare associated infections in myeloma patients.

The NIHR is hosting a wide range of commercial and non-commercial myeloma treatment trials and studies through its Clinical Research Network, biomedical research centres, clinical research facilities, and through experimental cancer medicine centres funded jointly with Cancer Research UK.

NHS Blood and Transplant (NHSBT) responsible for the supply of blood, organs, tissues and stem cells and manages the British Bone Marrow Registry (BBMR) and the NHS Cord Blood Bank. NHS BT and provides specialist services related to the provision of stem cells which can turn into blood cells for the treatment of blood cancers. NHSBT recruits stem cell donors to the BBMR exclusively from the pool of active blood donors (aged 17 years and above), and undertakes awareness raising activity.

NHS Blood and Transport (NHSBT) manages the British Bone Marrow Registry (BBMR), the NHS Cord Blood Bank and provides specialist services related to the provision of stem cells which can turn into blood cells for the treatment of blood cancers and is responsible for raising awareness of these issues.

NHSBT recruits stem cell donors to the BBMR exclusively from the pool of active blood donors (aged 17 years and above), however those wishing to join at age 16, can do so through Anthony Nolan.

All registered stem cell donors are in the UK's aligned Register. Anthony Nolan manages this single UK bone marrow register, which is known as the 'Anthony Nolan & NHS Stem Cell Registry', and is aligned with the NHS British Bone Marrow Registry and the Welsh Bone Marrow Donor Registry.

NHSBT has programmes in place to support education about donation and transplantation for children and young adults including Give and Let Live, a national education programme aimed at promoting awareness of bone marrow, blood, tissue, cord blood and organ donation amongst 14-16 year old pupils.

Within the UK strategy ‘Taking Organ Transplantation to 2020’ (published in July 2013 and available at www.nhsbt.nhs.uk/to2020/), the UK Government Health Departments have agreed to explore with Education Departments the possibility of incorporating donation and transplantation into schools’ curricula.

No estimate has been made as this information is not held centrally.

NHS England has published service specifications for both child and adult haematopoietic stem cell transplantation which sets out that a clearly defined programme of after care should be developed with the patient following treatment. The specifications are important in clearly defining what NHS England expects to be in place for providers to offer evidence-based, safe and effective services. They ensure equity of access to a nationally consistent, high quality service for patients.

NHS England is supporting a two year programme of work in collaboration with Macmillan Cancer Support to develop and implement evidence based findings from the National Cancer Survivorship Initiative. There are four agreed priorities:

implementation of the four components of the Recovery Package;

promoting the benefits of physical activity as part of treatment and follow up care;

implementation of risk stratified pathways supported by evidence based surveillance; and

improved knowledge and management of consequences of treatment.

Improvement in knowledge of the late effects of cancer treatment, including haematological cancers to inform commissioning of services, is one of four priority work areas for the next two years. There are already examples of services being commissioned directly by NHS England to meet complex and rare late effects of cancer treatment. If the emerging evidence indicates the need for additional services which fulfil the criteria for NHS England prescribed services, then this would be the advice provided by the National Cancer Survivorship Initiative to the NHS England Board.

This information is not held centrally.

This information is not held centrally.

The information is not available in the format requested. Such information as is available is in the following table.

NHS England has advised that the British Society of Blood and Marrow Transplantation reported in 2013 that for all patients treated in United Kingdom centres, five year survival of patients who have received a bone marrow transplant between 2005 and 2010 was 55% for adults and 64% in children.

Note:

This survival data may include deaths that are unrelated to the bone marrow transplant.

NHS England has service specifications to support its work around transplantation and to ensure the equitable and consistent commissioning of specialised care. NHS England is committed to working with other commissioners involved in the pathway of care for bone marrow transplantation patients.

NHS England has signalled the importance of access to late effects services, for people recovering from bone marrow transplants, through their inclusion in the service specifications in place to ensure equitable and consistent commissioning of specialised care. The Blood and Marrow Transplant Clinical Reference Group (BMT CRG) are continuing to review the service specification and any significant changes will be consulted upon further.

Helping people to recover from episodes of ill-health or following injury is one of the NHS Outcomes Domains relevant to bone marrow transplantation. The CRG will consider this and other outcome measures as part of the next review of the service specification. Through its direct commissioning function, NHS England aims to deliver improvements for populations and individuals as set out in the Outcomes Framework. While the priority of BMT is to prevent people from dying prematurely, enhancing the quality of life of patient's post-transplant is also very important.

NHS England recognises that BMT is a complex treatment for a range of complex conditions which affect not only the patient, but their families too. The BMT CRG includes the voices of carers to ensure

policy that is developed reflects these issues. NHS England will work with other commissioners, through the CRG and other partnerships, to continue to support the availability of appropriate family support services.