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Standards and accreditation for innovative cellular therapies

by Eoin McGrath

Since early 2018, the JACIE standards have been extended to include administration of Immune Effector Cells (IEC), a group of cellular therapy products which includes Chimeric Antigen Receptor T-cell (CAR-T) therapies.

Given the novel and complex nature of these innovative therapies, the main focus of the standards is on patient management and care in the clinical setting. Aside from general requirements for all cellular therapies, the standards set out more specific requirements for staff training and experience, interactions with other specialities including cell collection and storage, intensive care, nursing, neurology and pharmacy services, follow-up of patients including data reporting to registries and management of adverse events.

While largely a voluntary scheme, JACIE is a requirement for centres performing stem cell transplantation in countries such as Belgium, France, The Netherlands, Switzerland and the United Kingdom. In 2018, the national health service of England (NHS England), before designating service providers for CAR-T, further required that applicant centres underwent a JACIE technical assessment of their readiness.

The EBMT considers that the JACIE model offers a practical solution in establishing the required levels of readiness in units preparing to offer CAR-T cell therapy and provides an indicator of high quality practice to patients, healthcare professionals, regulators and payers. The standards closely follow developments in the field and preparations for the 8th edition, due to be released in March 2021, will commence this summer.