Navigating regulations to provide ethically sourced cellular material for research and development: UK perspective

Anthony Nolan is a UK based charity first set up by Shirley Nolan to find a matched hematopoietic stem cell donor for her son, Anthony. To this day our mission remains the same, to save and improve the lives of everyone who needs a hematopoietic cell transplant (HCT). Anthony Nolan has over 45 years’ experience of working with donors via the stem cell registry to provide hematopoietic cells for patients in need of a transplant across the globe. Along our journey in supporting HCT patients, we have evolved to ensure that we continue to do our best for the patient community. Our most recent evolution has resulted in the establishment of our Cell and Gene therapy services. Anthony Nolan is not unique in this transition, the National Marrow Donor Programme a Registry based in the United States of America, launched its Be the Match Biotherapies in 2016 to provide cell sourcing and supply chain management services for allogenic cell therapy development and Gift of Life Marrow Registry also in the United States of America has developed Gift of Life Biologics, an all-in-one solution for cell and gene therapy developers. An important aspect of the Anthony Nolan service is that the biological materials we provide to our clients will always be high quality and ethically sourced from well informed donors, allowing our clients to scale up from early proof of concept research on to the clinical trial stage. In the context of this article the term starting material will cover, mobilized peripheral blood stem cell collection, bone marrow collection, donor lymphocyte collection and whole blood collection as well as umbilical cord blood and tissue. In the field of cell and gene therapy where it is essential to ensure the end-product is safe and clinically effective the quality of all starting materials, including human cells is paramount. Human starting material by nature is complex; we have variability in the quality and content between different people, the global regulatory framework is ambiguous and emerging, it is considered a high-risk material requiring screening and evaluation of donors and their collected material. Most importantly it requires an individual, in our case a donor to consent to undergo a medical procedure to donate the precious cells for use in research, this does not apply to the umbilical cord material. In the UK it is illegal to pay for human body parts, this also applies to Europe, therefore our donors donate purely for altruistic reasons. This last point can sometimes be overlooked and therefore the ethical implications of obtaining this material are not considered as part of the cell therapy development plan.

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