World-first clinical trial sees BioResource volunteers receiving transfusion of laboratory grown red blood cells

Volunteers from our general population cohort matching the specific blood group type of NHS Blood and Transplant (NHSBT) donors were invited to take part in this ground-breaking research that has huge potential for improving efficacy and safety of blood transfusions.

hands in disposable gloves extracting blood from test tube using syringe

World first for red blood cells 

The manufactured blood cells were grown from stem cells from donors. The red cells were then transfused into participating BioResource volunteers in the RESTORE randomised controlled clinical trial. 

Whilst there has been transfusion of lab-grown cells back into the person who donated the stem cells originally, this is the first time in the world that red blood cells that have been grown in a laboratory have been given to another person as part of a trial into blood transfusion.  

If proved safe and effective, manufactured blood cells could in time revolutionise treatments for people with blood disorders such as sickle cell and rare blood types. It can be difficult to find enough well-matched donated blood for some people with these disorders.

 What is the RESTORE trial? 

RESTORE aims at establishing whether cultured red cells have a survival advantage over the standard donated red cells post-transfusion. The RESTORE trial is a joint research initiative by NHS Blood and Transplant and the University of Bristol, working with the University of Cambridge, Guy’s and St Thomas’ NHS Foundation Trust, NIHR Cambridge Clinical Research Facility, and Cambridge University Hospitals NHS Foundation Trust. It is part-funded by a National Institute for Health and Care Research grant. 

The role of the BioResource 

In order to carry out the study, the research team needed to match red cell and stem cell donors with healthy recipients. The red cell matching had to go further than simply ABO and RhD (Rhesus) blood groups and required an additional 12 antigens to match for. The study required identification of a population of highly phenotyped volunteers to match to the donor cohort at NHSBT. 

Professor Cedric Ghevaert, Professor in Transfusion Medicine and Consultant Haematologist the University of Cambridge and NHS Blood and Transplant, said:

"The BioResource provided the necessary infrastructure to enable this development, not only with the phenotypic information of potential participants but because of the access it gave the RESTORE team to contact these volunteers and enable recruitment.

The benefits of lab-grown cells 

If manufactured cells last longer in the body, patients who regularly need blood may not need transfusions as often. That would reduce iron overload from frequent blood transfusions, which can lead to serious complications. 

 The trial is the first step towards making lab grown red blood cells available as a future clinical product. For the foreseeable future, manufactured cells could only be used for a very small number of patients with very complex transfusions needs.   

Two BioResource volunteers have so far been transfused with the lab grown red cells (dosage around one to two teaspoons). They were closely monitored and no untoward side effects were reported. They are well and healthy.  

Professor Ghevaert added:

“We hope our lab grown red blood cells will last longer than those from blood donors. If our trial is successful, it will mean that patients who require regular long-term blood transfusions will need fewer transfusions in future, helping transform their care.”

New trial a significant step   

A minimum of 10 BioResource volunteer participants will receive two mini transfusions at least four months apart, one of standard donated red cells and one of lab grown red cells, to find out if the young red blood cells made in the laboratory last longer than cells made in the body.  

Further trials are needed before clinical use, but this research marks a significant step in using lab grown red blood cells to improve treatment for patients with rare blood types or people with complex transfusion needs. 

John James OBE, Chief Executive of the Sickle Cell Society, said:

"This research offers hope for those difficult to transfuse sickle cell patients who have developed antibodies against most donor blood types.
The NHS still needs 250 blood donations every day to treat people with sickle cell and the figure is rising. We strongly encourage people with African and Caribbean heritage to register as blood donors and start giving blood regularly.”

If you are interested in working with the NIHR BioResource to support your research, please get in touch. If you are interested in volunteering with the BioResource so you can be part of future research we support, we’d love to hear from you. 

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