First volunteers to receive blood cultured from stem cells in 2016
Red blood cells cultured in a laboratory will be trialled in human volunteers for the first time within the next three years, as part of a long-term research programme funded by the Wellcome Trust.
The £5 million Strategic Award was granted to a consortium led by the Scottish National Blood Transfusion Service (SNBTS), and will follow on from previous research that proved that red blood cells could be generated from stem cells.
The consortium includes the University of Glasgow, the University of Edinburgh, Loughborough University, NHS Blood and Transplant, the Irish Blood Transfusion Service, Roslin Cells Ltd and the Cell Therapy Catapult, in collaboration with Bristol University and the University of Cambridge.
The consortium will be using pluripotent stem cells, which are able to form any other cell in the body. The team will guide these cells in the lab to multiply and become fresh red blood cells for use in humans, with the hope of making the process scalable for manufacture on a commercial scale. The team hopes to start the first-in-man trial by late 2016.
Blood transfusions play a critical role in current clinical practice, with over 90m red blood cell transfusions taking place each year worldwide. Transfusions are currently made possible by blood donation programmes, but supplies are insufficient in many countries globally. Blood donations also bring a range of challenges with them, including the risk of transmitting infections, the potential for incompatibility with the recipient's immune system and the possibility of iron overload. The use of cultured red blood cells in transfusions could avoid these risks and provide fresh, younger cells that may have a clinical advantage by surviving longer and performing better.
Professor Marc Turner, Principal Investigator, said: "Producing a cellular therapy which is of the scale, quality and safety required for human clinical trials is a very significant challenge, but if we can achieve success with this first-in-man clinical study it will be an important step forward to enable populations all over the world to benefit from blood transfusions. These developments will also provide information of value to other researchers working on the development of cellular therapies."
Dr Ted Bianco, Director of Technology Transfer at the Wellcome Trust, said: "Harnessing the power of stem cell biology to contribute to healthcare is one of the most exciting opportunities we can expect to see reach fruition in the coming years. But one should not underestimate the challenge of translating the science into routine procedures for the clinic. Nowhere is this more apparent than in the challenge Professor Turner and colleagues have set out to address, which is to replace the human blood donor as the source of supply for life-saving transfusions, knowing that each unit of blood contains no less than a trillion red cells."
Before clinical trials can begin the cultured cells will have to be manufactured to a very high standard and be approved by UK regulatory authorities.