STH has a successful track record in delivering commercial and non-commercial clinical research, working closely with its main partner organisation The University of Sheffield, with active research teams in most therapy areas.

STH Clinical Research & Innovation Office (CRIO) is committed to providing high quality and timely clinical trial set up, contracting and management across all genres of commercial and non-commercial clinical research throughout the Trust including Advanced Therapy Medicinal Products (ATMP) trials.

The National Institute of Health and Care Research (NIHR) Sheffield Clinical Research Facility (CRF) is sited across two hospitals within STH providing purpose-built facilities and dedicated research staff to support the conduct of a wide range of high-quality clinical research, with a focus on supporting early phase, experimental medicine and complex studies. The CRF also provides outreach services for studies dependent on delivering research in their own clinical environment within the Trust.

The STH Cancer Clinical Trials Centre is sited at Weston Park Hospital and has extensive experience in delivering early phase and experimental clinical trials including ATMPs in the fields of somatic cell therapy, oncolytic viral therapy, gene therapy and cancer vaccines.

STH hosts an NHS Blood and Transplant (NHSBT) apheresis collection service (procurement) at the apheresis unit within the Royal Hallamshire Hospital. NHSBT holds an import and export license on behalf of the Trust (distribution). NHSBT stem cell lab and associated ATMP facility in Barnsley provide management and storage of ATMP Chimeric Antigen Receptor- T (CAR-T) cells. This includes receiving, labelling, quality assessing, cryopreserving, storing, importing and exporting, managed through a Service Level Agreement with STH. Production of ATMP is not currently performed but can be introduced as the Barnsley stem cell lab is designed for such production.

STH Haematology unit based at Royal Hallamshire Hospital is a JACIE (Joint Accreditation Committee of ISCT & EBMT) certified, and NHS England (NHSE) commissioned stem- cell transplant and cell therapy unit. This CAR-T therapy team now provide standard of care for patients with acute lymphoblastic leukaemia or lymphoma in specific circumstances. They have adequate provision for up to 14-day inpatient periods on the Haematology wards with robust Immune effector cell-associated neurotoxicity syndrome (ICANS) and Cytokine Release Syndrome (CRS) monitoring. Within the clinical research setting the Haematology unit is building links with CRF and CRIO to support CAR-T and other cellular studies and streamline review and set up processes.

STH Pharmacy has a dedicated ATMP team and a dedicated clinical trials team including a dedicated Principal Pharmacist for ATMPs.

STH hosts the NIHR Sheffield Biomedical Research Centre (BRC), which aims to bridge the gap between new discoveries and the development of improved treatments, diagnostics, medical technologies and policy changes, ultimately improving patient care of people with long term health conditions. The Sheffield BRC has expanded from an initial focus on Neurosciences to also include themes on Cardiovascular Disease, Infection & Immunity and Imaging & Engineering.

STH Advanced Therapy Medicinal Products and Genetic Modification Safety Group provides quality and safety assurances for all aspects of ATMP procurement, storage, management and use within STH for both clinical and research activities and provides advice to the Trust on the contained use of Genetically Modified Organisms (GMOs) within the clinical and research facilities.

STH’s ATMP capabilities include:

• Experience in delivering both cell and gene therapy clinical trials in a variety of disease areas.
• NHSE approved centre for provision of licensed CAR- T products.
• JACIE certification.
• Apheresis unit.
• Class I ATMPs.