Published: 07 November 2022
A world-first clinical trial funded and supported by NIHR has started giving lab-grown red blood cells to people. If proved safe and effective, the technology could revolutionise treatments for people with rare blood types, blood disorders such as sickle cell, or people who aren’t able to have normal blood transfusions.
The RESTORE clinical trial (REcovery and survival of STem cell Originated REd cells) was initiated by the NIHR Blood and Transplant Research Unit in Red Blood Cell Products. Stem cells in the blood, which can generate new blood cells, are separated out from donated blood and are then grown to produce red blood cells in the laboratory. The researchers are studying the lifespan of the lab-grown cells, compared with normal blood cells from the same donor. The lab-grown blood cells are all fresh, so the trial team expects them to perform better than a similar transfusion of standard donated red cells, which contains cells of varying ages.
The manufactured cells are labelled with a tracer element so the researchers can detect the cells in blood samples and work out how long they last. If manufactured cells last longer in the body, patients who regularly need blood may not need transfusions as often. That would reduce serious complications that can be caused by having transfusions regularly.
The people taking part in the trial are healthy volunteers who were recruited from the National Institute for Health and Care Research (NIHR) BioResource. Two people have so far been given the lab grown red cells at the NIHR Cambridge Clinical Research Facility. They were closely monitored and no untoward side effects were reported. They are well and healthy. 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.
The trial is the first step towards making lab-grown red blood cells more widely available. However, for the foreseeable future, manufactured cells could only be used for a very small number of patients with very complex transfusion needs.
Further trials are needed before the lab-grown cells can be used on a larger scale, but this research marks a significant step in using lab-grown blood to improve treatment for patients. 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.
Professor Lucy Chappell, Chief Executive of the NIHR said:
"These NIHR-supported researchers have made it possible to grow blood in the lab, turning what sounds like science fiction into a ground-breaking reality. Giving lab-grown blood could offer crucial treatments to people who aren't suitable for normal blood transfusions. This is really exciting progress that is another example of the world-leading life sciences opportunities that the UK has to offer."
Professor Ashley Toye, Professor of Cell Biology at the University of Bristol and Director of the NIHR Blood and Transplant Unit in red cell products, said: “This challenging and exciting trial is a huge stepping stone for manufacturing blood from stem cells.”
Dr Farrukh Shah, Medical Director of Transfusion for NHS Blood and Transplant, said: “Patients who need regular or intermittent blood transfusions may develop antibodies against minor blood groups which makes it harder to find donor blood which can be transfused without the risk of a potentially life-threatening reaction. This world leading research lays the groundwork for the manufacture of red blood cells that can safely be used to transfuse people with disorders like sickle cell. The need for normal blood donations to provide the vast majority of blood will remain. But the potential for this work to benefit hard to transfuse patients is very significant.”
Neil O’Brien, Minister of State for Health, said: “This research, backed by government investment, represents a breakthrough for patients and means treatment could be transformed for those with diseases including sickle cell. Once again this shows the UK is leading the world when it comes to scientific innovation and collaboration while delivering high quality care to those who need it the most.”