The Trust is in the North East of England and is main tertiary care center for North East and North Cumbria. Spanning from east to west, the patient catchment area is 3.2 million people. Population is diverse, representing a wide range of ethnicity and social class, including some of the most deprived regions in the UK. Our well-located Trust sites enable easy access and strengthen recruitment through community services and general practitioners (GP) practices.

Our dedicated research facilities and 350+ staff offer the ability to undertake trials from phase 1/ first in human to phase 4/ post-marketing conducting basic research through to complex advanced therapies at all sites. Our staff oversee around 1.84m patient ‘contacts’ each year, delivering high standards of healthcare across our sites. We have more nationally accredited specialist services than any other group of hospitals in the UK, and work closely with partner organisations, including Newcastle University, commercial life sciences, clinical research organisations, and the National Institute for Health and Care Research (NIHR).

With a strong track record in Advanced Therapy Medicinal Product (ATMP) clinical research, The Newcastle upon Tyne Hospitals NHS Foundation Trust (Newcastle Hospitals) offers suppliers, sponsors and researchers a reliable partnership for the design, production, and delivery of advanced therapy products as trials or licensed medicines. We have JACIE (Joint Accreditation Committee of ISCT & EBMT) certification and licensed (Medicines and Healthcare products Regulatory Agency (MHRA) and Human Tissue Authority (HTA)) Good Manufacturing Practice (GMP) cleanroom facilities across two sites at the Royal Victoria Infirmary (cell, gene and tissue laboratory) and the International Centre for Life (GMP manufacturing facility). Pharmacy aseptic capability is integrated with stem cell processing capability, including comprehensive cold storage facility with robust governance and oversight. Dedicated infrastructure offers operational expertise within our NIHR Clinical Research Facility (CRF), and our patient-focused delivery models within Newcastle Hospitals support accelerated timelines and consistent trial outcomes. By combining specialist clinical expertise with robust governance and operational oversight, we aim to help sponsors bring innovative therapies to patients efficiently and effectively.

Our key strengths are: –

Clinical Expertise

Specialisation in Oncology, Haematology, Rare diseases, Neurology, Diabetes, Metabolic and Endocrine, Ophthalmology, Toxicology & Emergency medicine, Regenerative medicine and Inflammation & Immunology. Our manufacturing facility is experienced in cell culture, isolation, selection, cryopreservation, and aseptic manufacturing. Our multidisciplinary team is one of few UK centres to offer total pancreatectomy islet isolation autologous transplantation as a clinical service. Experience in delivering both cell and gene therapy clinical trials, ability to carry out class 1 & 2 gene therapy studies, 2 Apheresis units (one for adults and one for children) and an NHS England (NHSE) approved centre for provision of licensed chimeric antigen receptor T (CAR- T) cells products.

Specialist care

Newcastle is the largest provider of specialist clinical haematology healthcare for patients in the North of England and we receive referrals from all over the region. We treat approximately 1000 new patients every year and many more patients come to see us regularly for longer term treatments.

Haematology services at Royal Victoria Infirmary (RVI) and Freeman Hospital

The clinical haematology service at the RVI is the base for the Regional Haemophilia Comprehensive Care Centre which looks after patients from all over the Northern region and beyond with haemophilia and other bleeding disorders, as well as the Regional Specialist Haemoglobinopathy Service. The team also liaises with paediatric haematology services based in the Great North Children’s Hospital. The team at the Northern Centre for Cancer Care, Freeman Hospital focuses on the management of malignant haematological disorders. Patients who need to be admitted to hospital are cared for on Wards 33, 34 and 35, here we carry out stem cell collections and provide apheresis, chemotherapy and other supportive infusions. We also have a day unit, Ward 36, where we carry out patient reviews. The department is also home to the Northern Centre for Bone Marrow Transplant – a commissioned centre for CAR-T cell therapy.

The NIHR Clinical Research Facility

Newcastle CRF conducts early phase experimental medicine research trials in adults and children. It has ten inpatient beds and a dedicated paediatric area, and investigates novel treatments including immune-modulating, gene correction, and cell-based therapies.

Operational Group for Advanced Therapies

Serving as a central hub for addressing local barriers, facilitating ATMP trials acceleration.

Significant ‘firsts’

  • First in the world in recruiting to a fully regulated clinical trial of direct stem cell therapy for strokes
  • First in Europe: Newcastle researchers dosed the first patient in Europe in a clinical trial to find treatments for late-onset Pompe disease
  • First in the UK to treat patients with gene therapy for Duchenne muscular dystrophy (DMD).

Oncology, Haematology, Rare diseases, Neurology, Diabetes, Metabolic and Endocrine, Ophthalmology, Toxicology & Emergency medicine, Regenerative medicine and Inflammation & Immunology.

  • The Advanced Therapies Medicinal Product and Genetically Modified Safety Oversight Committee (ATMP Oversight Committee)
  • New Interventional Procedure Committee (NIPC) when the administration of an ATMP used as a treatment involves an interventional process that has not been carried out before in the Newcastle Hospitals Trust.