Apheresis procedures for the treatment of patients and for the collection of cellular therapy products

Since the publication of the previous BSH apheresis guideline in 2015,¹ there have been a number of changes affecting workload and clinical practice for most apheresis services. First, there has been a steady increase in the use of ATMP such as chimeric antigen receptor T (CAR-T) cells,² which require apheresis for the procurement of autologous or allogeneic lymphocytes as starting material for manufacture, with most services experiencing increased clinical and regulatory burdens as a consequence. Second, there has been a change in referral patterns for plasma exchange. Autoimmune encephalitides have now emerged as one of the top 10 indications based on steadily increasing evidence for efficacy.³ In contrast, patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (one of the top 10 indications for plasma exchange discussed in the 2015 Guideline) are now less commonly referred. This change is largely due to the results of the PEXIVAS study, which have cast doubts on whether plasma exchange has any impact on overall survival or on renal outcomes in this condition.⁴ However, a recent UK renal medicine consensus statement still makes a weak recommendation for consideration of plasma exchange in a subset of ANCA vasculitis patients.⁵ Finally, there is a clear expectation that gene therapy for sickle cell disease (SCD) and related conditions, which has shown promising results in multiple pre-clinical trials,⁶ will move into routine use in the UK National Health Service (NHS) over the next decade, with a potential increased demand for PBSC collections to provide starting material for manufacture. However, this advancement could come with some associated clinical and logistical challenges such as potential use of single-agent plerixafor for PBSC mobilisation from SCD patients due to the risks of granulocyte-colony stimulating factor (G-CSF)-based PBSC mobilisation in this patient group.⁷

This 2025 revision of the apheresis guidelines updates advice on managing current and anticipated future demand in the UK NHS. As for the 2015 Guideline, the remit of the current guideline covers all plasma exchange regardless of equipment used, all therapeutic procedures undertaken on cell separators, and any autologous or allogeneic donor apheresis for procurement of cellular therapy products (CTPs) such as haematopoietic progenitor cell apheresis (HPC-A), but excludes apheresis performed for procurement of blood components. The primary objective remains to provide healthcare professionals with clear guidance on the use of clinical apheresis.