Professor Ash Toye discusses what the Restore trial is

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Red blood cells grown from stem cells in a laboratory have been transfused into two individuals, with no untoward side effects, in a world-first UK clinical trial. Should the procedure prove safe and effective, manufactured blood cells have the potential to revolutionise transfusions for people with blood disorders like sickle cell disease and those with rare blood types, for whom sourcing well-matched donated blood can be difficult. The “RESTORE” trial is a joint research initiative between NHS Blood and Transplant and the University of Bristol, in tandem with other partners. As part of the randomised and controlled trial, at least eight more participants will receive two mini blood transfusions — one of standard blood cells and one of their lab-grown counterparts — at least four months apart. The concept will not replace the need for blood donations — and, in fact, it requires stem cells from donated blood. However, it should allow donors to help treat more people.

Study author and cell biologist Professor Ashley Toye of the University of Bristol said: “This challenging and existing trial is a huge stepping stone for manufacturing blood from stem cells.

“This is the first time lab-grown blood from an allogeneic [genetically dissimilar] donor has been transfused and we are excited to see how well the cells perform at the end of the clinical trial.”

A key aim of the RESTORE trial is to compare the lifespan of the manufactured cells with those sourced directly from the blood of the same individuals who donated the stem cells.

To achieve this, the lab-grown cells have been labelled with a tracer element that will allow the team to detect them in the recipients’ blood, which will be assessed over the six-month period following the blood infusion.

Because the lab-grown cells are all “fresh”, the researchers expect them to perform better than their counterparts in a standard transfusion, which would inherently be of varying ages.

The typical lifespan of a single red blood cell is around 120 days, after which the body removes them from the bloodstream and breaks them down in organs like the spleen and liver.

Transfusion specialist Professor Cedric Ghevaery, of the University of Cambridge, said: “We hope our lab grown red blood cells will last longer than those that come from blood donors.

“If our trial, the first such in the world, is successful, it will mean that patients who currently require regular long-term blood transfusions will need fewer transfusions in the future, helping transform their care.”

One advantage of this — alongside the convenience of reducing the total number of procedures needed — is that it reduces the risk of iron overload, or “haemochromatosis”.

Such can lead to serious complications, including arthritis, diabetes, cirrhosis, liver cancer and even heart failure.

Donors for the study were recruited from NHS Blood and Transplant’s blood donor base, with stem cells filtered out of the blood samples taken and then grown into red blood cells.

The recipients of the transfusions — both lab-grown and regular — were all healthy volunteers recruited from the National Institute for Health and Care Research BioResource.

According to the researchers, each subject being given the stem-cell derived red blood cells is receiving around five–ten millilitres, or around one–two teaspoons.

NHS Blood and Transplant’s Head of Component Development, Dr Rebecca Cardigan, said: “It’s really fantastic that we are now able to grow enough red cells to medical-grade to allow this trial to commence.

“We are really looking forward to seeing the results and whether they perform better than standard red cells.”

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According to NHS Blood and Transplant, the RESTORE trial is the first step towards making lab-grown red blood cells available clinically.

For the foreseeable future, however, manufactured cells will likely only be used for a very limited number of patients with “very complex” transfusion needs.

NHS Blood and Transplant’s Medical Director of Transfusion, Dr Farrukh Shah, said: “Patients who need regular or intermittent blood transfusions [can] develop antibodies against minor blood groups, which make 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-transfer patients is very significant.”

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