Novosang has carried out extensive research with regards to generating red blood cells from pluripotent stem cells. We have developed a protocol to produce red blood cells from human embryonic stem cells that meet good manufacturing process guidelines. This means we could produce cells that would be of a quality suitable for clinical use.
We hope to translate our laboratory work into a clinical setting. A first-in-man trial would demonstrate the recovery and survival of cultured red blood cells following transfusion (CTC). All the Blood Services in the UK are associated with our work.
The trial will be run once the appropriate regulatory approval has been obtained from the UK authorities including the Medicines and Healthcare Products Regulatory Authority and the appropriate Ethics and NHS Research and Development Committee approvals
We predict that newly cultured red blood cells would be younger than cells in donated blood – some of which are nearing the end of their 120-day lifespan – and, as a consequence, will survive for longer after transfusion. This could be a significant advantage to patients who require repeated transfusions to treat conditions such as thalassaemia.
Novosang’s culture system is also able to generate red blood cells from induced pluripotent stem cells (iPSCs). The advantage of iPSC lines is that they can be generated from cells taken from donors with specific blood groups – for example skin samples can be programmed to become iPSCs – which can then be differentiated to generate red blood cells matched to that blood group. This would reduce alloimmunisation – a concern in patients undergoing frequent transfusions – that is caused by antibody development against antigens in transfused blood.
We are now working on creating O Rhesus negative red blood cells from human induced pluripotent stem lines. The O Rhesus negative blood group is often referred to as the ‘universal donor' as it can be given to patients with different blood types.
We consider it very important to gauge public opinion about the use of cultured red blood cells derived from pluripotent stem cells and the acceptance of such a source of blood. As such, we are conducting qualitative research with interviews and focus groups. This involves participants including patients, religious organisations and community groups (Catherine Lyle).