In-man trials of manufactured blood within two years
25 June 2015
LAB produced red blood cells are set to be transfused into humans by 2017, NHS Blood and Transplant announces.
The landmark in-man clinical trials of manufactured blood form a key part of the blood and organ service's 2020 Research and Development
Published today (25/6/15) the plan outlines how NHS Blood and Transplant, in partnership with leading universities, will develop transfusion,
transplantation and regenerative medicine over the next five years.
Dr Nick Watkins, NHS Blood and Transplant Assistant Director of Research and Development said: "Scientists across the globe have been
investigating for a number of years how to manufacture red blood cells to offer an alternative to donated blood to treat patients. We are
confident that by 2017 our team will be ready to carry out the first early phase clinical trials in human volunteers.
"These trials will compare manufactured cells with donated blood. The intention is not to replace blood donation but provide specialist
treatment for specific patient groups.
"Research has laid the foundation for current transfusion and transplantation practices. Continued investment in research and development
is critical to our role in saving and improving lives through blood and organ donation. Our five-year research and development plan will ensure
we advance treatment of all who depend upon our products and services.
"The manufactured red cell trials form part of our world-leading work in regenerative medicine and one of eight research goals for 2015-2020
that will bring long-term improvements for patients and donors."
Scientists from NHS Blood and Transplant and the Universities of Bristol, Cambridge and Oxford - led by Prof Dave Anstee and Dr Ashley Toye
- are using stem cells from adult and umbilical cord blood to create alternatives to donated blood. Previous work in this area has been enabled
by Wellcome Trust funding.
A key aim for the team is to create better-matched blood for patients with complex blood-types for whom it is difficult to find compatible
donors. Many of these patients will have blood conditions such as sickle cell anaemia and thalassemia which require treatment with regular
NHS Blood and Transplant has already set ambitious targets for organ and blood donation. The 2020 research and development plan focuses
investment in experimental medicine to support these. The National Institute for Health Research (NIHR) has committed £12.1 million funding
for three NIHR Blood and Transplant Research Units.
To meet patient needs, the service must reverse declining numbers of new blood donors, maintain a safe, sufficient and efficient supply,
and keep the price of blood as low as possible for the NHS.
In organ donation, NHS Blood and Transplant needs to significantly increase the number of lives saved through organ donation. This means by
2020 raising the number of families agreeing to donate a loved ones organs from 60 to 80% and increasing transplant rates by a third to 74 per
To help achieve these targets, research into behaviour change as a means to increase donation and consent rates will form another key strand
of the new five year research strategy.
Pioneering stem cell therapies will also be developed for those with life-limiting conditions. Research will be carried out to maintain
blood and organ safety, to improve evidence as to when blood transfusions should be used, and to assess new technologies to increase the
availability of donor organs for transplant.
George Freeman MP, Minister for Life Sciences said: "These exciting and pioneering developments demonstrate the world leading research being
done by our NHS. We are now working on an ambitious programme to further improve our work with donors and patients. NIHR funding will ensure we
can build on world-class research in transfusion and transplantation for patient benefit."
The NIHR Blood and Transplant Research Units will be embedded within a top university, and, in partnership with NHS Blood and Transplant,
will focus on rapid translation of research findings into routine practice in blood donation and in transplantation of stem cells and organs.
A decision regarding a possible fourth NIHR Blood and Transplant Research Unit is expected soon.
NHS Blood and Transplant Research and Development 2015 to 2020 Plan: Improving Outcomes for Patients and Donors.
- For additional information please contact Maggie Stratton on 01923 367609 email@example.com
- For out of hours enquiries please call the NHS Blood and Transplant Press Office on 0117 969 2444
Notes to editors
- NHS Blood and Transplant (NHSBT) is a joint England and Wales Special Health Authority. Its remit includes the provision of a reliable,
efficient supply of blood and associated services to the NHS in England and North Wales. It is also the organ donor organisation for the
UK and is responsible for matching and allocating donated organs.
- The eight research goals in NHS Blood and Transplant's 2020 Research & Development strategy are:
- Work in partnership with NIHR funded Blood and Transplant Research Units:
Enhance transfusion/transplantation microbiology and virology research to maintain blood, tissue and organ safety:
- Donor Health and Genomics (University of Cambridge) - Addressing blood donor health and strategies to enhance donor
safety while ensuring sustainability of blood supply.
- Organ Donation and Transplantation (University of Cambridge in partnership with Newcastle University) - Improving quality of
organs prior to donation through developing and evaluating novel approaches and technologies that increase the availability of
suitable donor organs for transplantation, while improving graft survival.
- Stem cells and immunotherapies (University College London) - Clinical translation of scientific advances and support
the development of new and improved stem cell-based treatments.
Clinical trials to support patient blood management
- In partnership with Public Health England, focusing on hepatitis E (HEV) and hepatitis B (HBV) and emerging infections
to maintain transfusion and transplant safety.
Regenerative medicine based therapies
- Completion of ongoing studies on appropriate platelet and red cell use in multi-transfused, neonates and patients with
low platelet counts. Clinical trial on patients requiring coagulation replacement.
Behavioural Research to identify interventions to increase donation and consent rates
- First-in-man clinical trial of manufactured red cells to compare the survival of red cells manufactured from stem cells
with that of standard red cells from blood donors. Continued support for pre-clinical science on manufactured red cells and
platelets with cell biology research to understand how stem cells turn into blood cells.
Big data translation to aid service improvement
- Set up of research strategy group across blood, tissues and organs to develop a programme of research in behavioural
Facilities and resources to support an innovative research programme
Workforce development to ensure skills and expertise to deliver R&D programme
- Development of Translational Data Science to utilise big data resources for donor and patient benefit, eg) applying
genomics data to post-treatment effects of transfusions and transplants.
The first NHSBT led clinical trial of manufactured red cells will involve a small group of around 20 volunteers who will receive a
small volume transfusion of between 5 and 10 mls of the lab produced blood.
In the search for ways to grow and create red blood cells, scientists worldwide are looking at stem cells from different sources.
NHS Blood and Transplant works in partnership with the Scottish National Blood Transfusion Service-led Blood Pharma project (funded by the
Wellcome Trust). This approach uses induced pluripotent stem cells (iPSCs) and NHSBT will lead on clinical trials for this project in
NHSBT collects 1.7 million units of blood each year. Hospitals need around 6,000 units a day to treat patients. Volunteer blood donors
remain vital for treating patients. Last year 40% fewer people came forward as new donors compared to a decade ago. NHS Blood and Transplant
has appealed for more new donors to come forward to make sure the nation's blood stocks remain at a safe level for the future - 204,000 new
donors in 2015 alone.
There are currently around 10,000 people in the UK in need of an organ transplant and every day 3 people die in need of a transplant.
One donor can save or transform up to nine lives and many more can be helped through the donation of tissues.
- Including increasing proportion of female group leaders and Principal Investigators, in line with the Athena-SWAN programme for academic centres.
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