The effect of COVID-19 on the UK cannot be underestimated. It has had ramifications far beyond those anyone could have predicted early in the outbreak. Across the UK, in all walks of life, businesses have needed to rapidly adapt; the same is true across the ATTC network. There have been significant contributions from partners across the network to help respond to the pandemic as well as the work hospitals have gone through to prepare for the introduction of Advanced Therapy Medicinal Products (ATMPs) has significantly benefited the vaccine rollout.
One of the challenges faced by the NHS regarding delivery of ATMP clinical trials or the adoption of licenced ATMPs has been the lack of experience in governing the handling of genetically modified organisms. The ATTC network has been influential in supporting the setup of genetic modification safety committees at hospitals. These committees have been instrumental in the rapid clinical testing of the vaccines for COVID-19. The experience gained from the inclusion of the COVID-19 vaccine trials is also developing an understanding that will support the requirements for gene therapies now coming to hospitals. The visual guide to non-cellular GMOs produced by MW-ATTC along with the MW-ATTC ’Introduction to ATMPs’ slide deck has been used to support delivery of staff training on COVID-19 vaccines in Wales
Training originally developed to support the safe handling and storage of ATMPs can be applied to the Pfizer/BioNTech vaccine; this has become a useful tool to educate staff on the hazards of transporting medicines in ultra-cold temperatures. For NHS staff this can be found on the e-Learning for Healthcare platform, https://www.e-lfh.org.uk/.
In Manchester, a clinical trial being set up to continuously monitor patients, being treated with an ATMP, for any rapid deterioration in their condition, was quickly pivoted to be able to monitor COVID-19 patients. The study uses wireless, wearable sensors, to continuously collect patients’ vital signs until either placed on a ventilator or discharged from hospital. Together with clinical data and observations, Artificial intelligence technology is employed to look for predictive patterns to see if this technology could be used to alert medical staff to a patient’s deterioration. Approximately 10-20% of hospital inpatients with COVID-19 will need intensive care. This trial aims to identify in advance, patients who will deteriorate and predict those who will need intensive care treatment to allow earlier intervention and lead to better chances of recovery. Further details can be found here: https://theattc.wpengine.com/imatch/cosmic-19-innovative-covid-19-clinical-trial-using-artificial-intelligence-opens-in-manchester
As part of the UK response to the pandemic, the Wellcome Trust funded REALIST-COVID clinical trial is assessing a novel allogeneic stromal cell therapy in a Phase 2 trial targeting Acute Respiratory Distress Syndrome (ARDS) caused by COVID19 – as well as non-COVID causes of ARDS. Reports indicate that 80-90% of COVID-19 related deaths are caused by ARDS and ICU patients with moderate-severe ARDS caused by COVID-19 have a 28-day mortality rate of ~35-40%. ORBCEL-C is a stromal cell therapy selected from umbilical cord tissues, developed by Orbsen Therapeutics. For this current REALIST Phase 2 clinical trial, ATTC partner NHSBT have manufactured ORBCEL-C under licence from Orbsen.
Building on their productive collaboration with MW-ATTC consortium, Orbsen are currently manufacturing ORBCEL-C at the University of Birmingham Advanced Therapies Facility for the subsequent Phase 2b/3 REALIST clinical trial initiation in Q4 2021. Further information can be found here: https://theattc.wpengine.com/midlands-wales/first-uk-covid19-patients-treated-with-allogeneic-cell-therapy-developed-by-attc-partner-orbsen-therapeutics
Utilising the networks formed across the country, the Northern Alliance Advanced Therapies Treatment Centre (NA-ATTC) and the Newcastle Advanced Therapies (a partnership between Newcastle University and The Newcastle upon Tyne Hospitals NHS Foundation Trust) supported the rapid set up of the REALIST-COVID trial at City Hospitals Sunderland NHS Foundation Trust.
The Directors of NA-ATTC have made significant contributions to the UK’s rapid vaccination programme, drawing in part on knowledge gained through delivering advanced therapies.
ATTC network partners have responded to the COVID-19 pandemic, applying learnings gained whilst introducing ATMPs into hospitals across the country; these have enabled the acceleration of the pandemic response and, likewise, there will be many learnings arising from this response which will be applicable to the adoption of ATMPs across the UK.
