The Trust works in close partnership with Imperial College London (ICL) as part of an Academic Health Science Centre (AHSC) and contributes to translational and clinical research programmes relevant to advanced therapies.

The Trust has an established Research & Innovation function, supporting both commercial and non-commercial clinical research, delivered in partnership with ICL. Clinical research governance, contracting and study setup are supported through the Imperial Joint Research Office (JRO), which covers studies hosted at Imperial College Healthcare NHS Trust. The Trust participates in National Institute for Health and Care Research (NIHR) supported research activity through its academic partnership and the NIHR Imperial Biomedical Research Centre (BRC), one of the NIHR’s major translational research investments in the UK.

Key infrastructure hosted by the Trust includes:

• The NIHR Imperial Clinical Research Facility (CRF) — dedicated space and expertise for early-stage and complex clinical trials, including an inpatient gene therapy suite for the preparation and delivery of Class I and II in-vivo and ex-vivo gene therapy products.
• Imperial Clinical Trials Unit (ICTU) — A UK Cancer Research Centre (UKCRC) registered, research-led, collaborative clinical trials unit.
• Specialised research facilities such as the Clinical Imaging Facility, Children’s Clinical Research Facility, Respiratory Research Unit, HIV Clinical Trials Unit, Hepatology Clinical Trials Unit, and tissue banks.
• Specialist pharmacy expertise and infrastructure to deliver Advanced Therapy Investigational Medicinal Products (ATIMP) clinical trials and licensed ATMP product; including in-vivo and ex-vivo gene therapies, somatic cell therapies and RNA “vaccine” therapies. The pharmacy team have an on-site aseptic unit and collaborate closely with the two Clinical Research facilities, the on-site stem cell lab (John Goldman Centre for Cellular Therapies), Haematology and the various specialised research units to enable safe delivery of novel and complex trials.
• Apheresis Unit – a specialist clinical service providing therapeutic apheresis procedures and stem cell collection across a range of conditions. It forms part of the Trust’s wider haematology and transplant services based mainly at Hammersmith Hospital (adult) and St Mary’s Hospital (paediatric). The range of therapeutic apheresis services include:
  • Therapeutic Apheresis: Treats adults and children.
  • Collection Apheresis: Autologous and donor Peripheral Blood Stem Cell Harvest (PBSH)/ donor lymphocyte collection.
  • Red Blood Cell Exchange (RBE): For haematology/neurology conditions, including sickle cell disease.
  • Therapeutic Plasma Exchange (TPE): For various haematology conditions.
  • White Cell and Platelet Depletions: Also performed in the unit.
• It is regulated by Care Quality Commission (CQC), Human Tissue Authority (HTA) and (JACIE) Joint Accreditation Committee of ISCT & EBMT standards.
• The John Goldman Centre for Cellular Therapy (JGCCT) – associated with cellular therapy and transplant-related activities. It supports commercial ATMPs and clinical trials for Haematology patients and ATMPs and clinical trials with cellular therapies for non-Haematology patients within the Trust. It has the capacity to work with GMO level 2 material (CT2). The JGCCT holds the following regulatory status:
  • Medicines and Healthcare Products Regulatory Agency (MHRA). Under our MHRA Specials licence, we also manufacture a range of advanced therapies for both our own patients and for Trusts across the UK. These include mesenchymal stromal cell (MSC) therapy for the management of steroid refractory graft versus host disease (GVHD), as well as virus specific T cells (CTLs) for the treatment of viral reactivation following allogeneic stem cell transplantation. These services form a key part of our broader commitment to providing timely, bespoke, cell-based interventions for complex transplant related complications.
  • Licence to conduct Good Manufacturing Practice (GMP) manufacturing and import authorisation (MIA) and Investigational Medicinal Products (IMPs)
  • Special licence for the manufacture and supply of advanced Medicinal Therapeutic Products
  • Human Tissue Authority (HTA)
    • Licence for procurement, testing, processing, storage, distribution and/or export of tissues and cells for human use
    • The HTA licence also authorises the holding of cells for research purposes
  • JACIE Accreditation
    • International Standards for Cellular Therapy and Immune Effector Cell (IEC) Collection, Processing and Administration

The Trust has expertise in ATMP delivery across a wide range of investigational and licensed products. Clinical expertise in ATIMP therapy pathways, including patient selection, apheresis coordination, administration and follow-up. With a strong multi-disciplinary delivery team and on-site adult and paediatric intensive care units plus a tertiary neurology service, we provide the highest levels of patient care throughout their ATMP journey and are able to offer inpatient, outpatient and ambulatory delivery. Multidisciplinary clinical teams spanning haematology, oncology, pharmacy, nursing, apheresis, laboratory services, clinical biosafety and research governance support ATMP delivery.