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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Viona
Rundell
+44 (0)7385 530070
viona.rundell@nhsbt.nhs.uk
Ms
Claire
Rourke
+44 (0)7385 964361
claire.rourke2@nhsbt.nhs.uk
More information about this study, what is involved and how to take part can be found on the study website.
Blood transfusion
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
About 1.5 million red blood cell (RBC) donations are collected by NHS Blood and Transplant and transfused each year, but there are a small number of patients with rare blood group types for whom NHS Blood and Transplant cannot meet the transfusion requirements. New RBCs can be grown from human blood stem cells in the laboratory (manufactured red blood cells, mRBCs). It is hoped that this will provide a novel transfusion product for these patients in the future, some of whom require regular transfusions throughout life (e.g. for thalassemia or sickle cell disease). Researchers want to find out whether mRBCs are safe and last longer in the circulation in the body than standard donated RBCs (sRBCs). The mRBCs are all young whereas in standard donated blood the RBCs will be of varying ages, from young cells to those that are reaching the end of their life span. Studies have shown that younger RBCs stay in the circulation for longer once they have been transfused. If the mRBCs last longer than the sRBCs this could mean that such cells could eventually reduce how often transfusions are needed in patients who are dependent on transfusions.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Current exclusion criteria as of 13/02/2024:Participant Exclusion Criteria (blood donors)Blood donors may not donate for the study if ANY of the following apply:1. Confirmed positive for any microbiological tests performed on blood donors on a sample tested at the time of donation (Hepatitis B (HBV), Hepatitis C (HCV), Hepatitis E (HEV), Human Immunodeficiency Virus (HIV), Human T-cell Lymphotropic Virus (HTLV), syphilis)2. A positive direct antiglobulin test (DAT)3. The presence of Sickle Cell Trait (HbAS), glucose-6-phosphate dehydrogenase (G6PD) deficiency, pseudohyperkalaemia4. Have plans to travel in regions that would justify their deferral as a blood donor at the time of donation5. Within 30 days of participating in another clinical trial, at the CI’s discretion6. Unable to use videoconferencing for study visits, at the CI's discretion
Participant Exclusion Criteria (recipients)Potential participants (recipients) may not enter the study if ANY of the following apply:screening tests.2. Previous splenectomy.3. Participation in another clinical trial within the last 30 days or currently participating in another clinical trial.4. Receipt of radio-isotopes within the last 12 months, unless given as part of the RESTORE trial.5. Past or present occupational exposure to radiation that necessitates or necessitated the wearing of a monitoring badge6. Known allergy to Cr-517. Known allergies warranting the use of adrenaline (EpiPen)8. Positive for clinically significant red cell alloantibodies, as detected by routine serological methods, including 3 cell screen.9. Positive for any other cross-match reactivity on screening.10. Positive pregnancy test11. Females that are breastfeeding12. Surgery planned for the period of study participation unless the CI/screening physician deems the risk of the participant experiencing substantial blood loss during that surgery as very low and unlikely to require a blood transfusion.13. Subject to enhanced COVID-19 restrictions at the time of recruitment, due to clinical status, at the physician’s discretion (e.g. “shielding” or “clinically vulnerable”).14. Unable to use videoconferencing for study visits, at the CI/trial physician’s discretion.
Previous exclusion criteria:Participant Exclusion Criteria (blood donors)Blood donors may not donate for the study if ANY of the following apply:1. Confirmed positive for any microbiological tests performed on blood donors on a sample tested at the time of donation (Hepatitis B (HBV), Hepatitis C (HCV), Hepatitis E (HEV), Human Immunodeficiency Virus (HIV), Human T-cell Lymphotropic Virus (HTLV), syphilis)2. A positive direct antiglobulin test (DAT)3. The presence of Sickle Cell Trait (HbAS), glucose-6-phosphate dehydrogenase (G6PD) deficiency, pseudohyperkalaemia4. Have plans to travel in regions that would justify their deferral as a blood donor at the time of donation5. Within 30 days of participating in another clinical trial, at the CI’s discretion
Participant Exclusion Criteria (recipients)Potential participants (recipients) may not enter the study if ANY of the following apply:1. Any clinically relevant abnormality on history, physical examination or laboratory screening tests2. Previous splenectomy3. Participation in another clinical trial within the last 30 days or currently participating in another clinical trial4. Receipt of radio-isotopes within the last 12 months5. Past or present occupational exposure to radiation that necessitates or necessitated wearing of a monitoring badge6. Known allergy to Cr-517. Known allergies warranting the use of adrenaline (EpiPen)8. Positive for red cell antibodies on screening.9. Positive for any other cross-match reactivity on screening.10. Positive pregnancy test11. Females that are breastfeeding12. Surgery planned for the period of study participation
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Claire
Rourke
+44 (0)7385 964361
claire.rourke2@nhsbt.nhs.uk
Ms
Viona
Rundell
+44 (0)7385 530070
viona.rundell@nhsbt.nhs.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by NHS Blood and Transplant R&D Office and funded by NHS Blood and Transplant; NIHR Central Commissioning Facility (CCF); Grant Codes: BTRU-2015-10032.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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You can print or share the study information with your GP/healthcare provider or contact the research team directly.
