Guy’s and St Thomas’ NHS FT have recruited and treated their first patients, in a first in human cell therapy trial for the treatment of post Covid-19 lung scarring.
The Monocytes as an Anti-fibrotic treatment after COVID-19 (MONACO) cell therapy study, is recognised as the world’s first Phase 1 trial for the condition. When looking at early estimates, 2% of all patients who had Covid-19 - including those not hospitalised - will have suffered a degree of fibrotic lung scarring as a result.
For those admitted to intensive care, estimations were even higher. The data also suggests that over 3.5 million people globally may have a degree of post Covid-19 lung scarring.
Lung scarring is known to cause a significant decline in lung function, a long-term debilitating reduction in exercise capacity, and reduced quality of life in these patients.
The trial looks at the safety and effectiveness of using a novel cell therapy treatment to reverse lung fibrosis, through using the body’s own cells (monocytes and macrophages), which are engineered in the laboratory to have anti-fibrotic properties.
Macrophages are a type of white blood cell with the power to remove cellular and excess scar tissue, formed in injured lungs as they heal during acute Covid-19 infection.
The study is led by Ashish Patel, Consultant Vascular Surgeon at Guy’s and St Thomas’, and a clinical senior lecturer within the King’s BHF Centre for Excellence, School of Cardiovascular Medicine and Sciences.
He commented: “I am very proud of how quickly our team has been able to progress this study from concept when the first wave hit, to dosing patients with the cell therapy product.
“Our research is focussed on developing novel advanced therapies and their translation from the laboratory to the bedside, and it has been fantastic being part of a truly translational piece of clinical research.
“Successful delivery of this experimental cell therapy into patients marks an important milestone in establishing its safety, before it is considered for treating larger numbers of patients who are affected by post Covid-19 fibrotic lung disease.
There were five patients with fibrotic lung disease, recovering from Covid-19, who were the first people in the world to receive the experimental cell therapy treatment, within the NIHR Clinical Research Facility (CRF) at Guy’s Hospital.
Mr Patel added: “I would like to extend my gratitude to the five incredible patients who have come through their severe Covid-19 illness and been so willing to participate in this first in human study. We could not have done this without their support.”
The development of the study and production of the treatment was made possible through the high quality infrastructure and facilities at the NIHR Guy’s and St Thomas’ Biomedical Research Centre (BRC).
The novel cell therapy used in the study was manufactured within the facilities, with the support of experts, highly trained, within the NIHR BRC’s Advanced Therapies Manufacturing platform at Guy’s Hospital.
Before the pandemic Mr Patel initially worked alongside vascular surgeon, Professor Bijan Modarai, with targets to deliver these cells into the legs of patients with peripheral vascular disease, to prevent amputation.
But, during the pandemic, as the number of patients who had recovered from Covid-19 with lung scaring increased, the surgeons took the opportunity to re-purpose their therapy to potentially treat this lung scarring.
Mr Patel concluded: “The rapid delivery of this study so far has been made possible by the fantastic infrastructure of the NIHR Guy’s and St Thomas’ BRC, including the very talented team within the BRC’s Advanced Therapies Manufacturing unit, as well as the regulators who have been excellent at closely working with us throughout this journey.
“The tireless efforts of the MONACO team, including Frederica Francia and Lily Benton, our vascular research nurses, has enabled us to set up the study and recruit patients in very quickly.
“As a vascular surgeon, respiratory disease is not my area of expertise and I am extremely grateful to colleagues and collaborators at Guy’s and St Thomas’, especially Dr Alex West, consultant respiratory physician, and lead of the KHP Interstitial Lung Disease Service.”
The trial is now closed for recruitment, but more can be found on current Covid-19 studies on the NIHR website.