A joint research initiative by NHS Blood and Transplant (NHSBT) and the University of Bristol is the first step towards making lab grown red blood cells available as a future clinical product.
Some patients require regular blood transfusions throughout their lives because of blood disorders such sickle cell and thalassaemia. However, it can be difficult to find enough well-matched donated blood for some people with these disorders.
New red blood cells can be manufactured in the laboratory from stem cells from donors. 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.
The world first RESTORE trial is a single centre randomised, controlled phase I cross-over trial in healthy volunteers. It is a joint research initiative by NHSBT and the University of Bristol, working with the University of Cambridge, Guy’s and St Thomas’ NHS Foundation Trust, National Institute for Health and Care Research (NIHR) Cambridge Clinical Research Facility, and Cambridge University Hospitals NHS Foundation Trust. It is part-funded by a NIHR grant.
The RESTORE trial is studying the lifespan of the lab grown cells compared with infusions of standard red blood cells from the same donor. The lab-grown blood cells are all fresh, so the trial team expect them to perform better than a similar transfusion of standard donated red cells, which contains cells of varying ages.
Additionally, 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. NHSBT continues to rely on the generosity of blood donors.
Donors were recruited from NHSBT’s blood donor base. They donated blood to the trial and stem cells were separated out from their blood. These stem cells were then grown to produce red blood cells in a laboratory at NHSBT’s Advanced Therapies Unit in Bristol. The recipients of the blood were recruited from healthy members of the NIHR BioResource.
During the trial a minimum of 10 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 they can be used clinically, 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.