Cell Therapy Catapult brings manufacturing, regulatory & market access expertise
The Cell Therapy Catapult, which is focused on the development of the UK cell therapy industry to increase the nation’s health and wealth, is delighted to be part of the BloodPharma consortium to which the Wellcome Trust has given a £5m Strategic Award1. The team, led by the Scottish National Blood Service, is working on the generation from stem cells of red blood cells, providing a new source which is expected to avoid many of the drawbacks associated with donated blood transfusions. Clinical trials to assess the safety of this new approach are expected to start at the end of 2016.
The research funded by the award involves multiplying and converting pluripotent stem cells into red blood cells for use in humans, with aim of making the process scalable for manufacture on a commercial scale. The Cell Therapy Catapult will be using its expertise to help deliver a robust manufacturing process, to develop the nonclinical and clinical studies, and provide guidance on data requirements for market access optimisation.
Keith Thompson, CEO of the Cell Therapy Catapult, said, ‘Blood transfusions play a critical role in current clinical practice, with over 90 million red blood cell transfusions taking place each year world-wide. We are very pleased to be part of this exciting BloodPharma consortium, using our expertise to help convert promising early-stage data into a robust cell therapy to serve this large area of medical need.’
Commenting on the trial plans, Professor Marc Turner, Principal Investigator & Cell Therapy Catapult Board member, 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.’
1 For the Wellcome Trust press release, please click here