Cell Therapy Trial for Post-Covid-19 Fibrotic Lung Disease a ‘World First’
Guy’s and St Thomas’ Hospital has announced the commencement of a Phase I clinical trial for the Monocytes as an Anti-fibrotic treatment after Covid-19 (MONACO) cell therapy study.
The clinical trial will assess the safety and efficacy of the novel cell therapy in reversing lung fibrosis in five patients who developed the condition following recovery from Covid-19.
“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,” Mr Ashish Patel, Consultant Vascular Surgeon and study lead, commented.
According to a recent release, early estimates have suggested that 2% of all hospitalised and non-hospitalised Covid-19 patients will have developed a degree of fibrotic lung scarring, with a higher percentage in patients admitted to intensive care. This would suggest that ~3.5 million people worldwide are likely to have a degree of post-Covid lung scarring.
Lung scarring can be debilitating, causing a decline in lung function, long term reduction in exercise capacity and general reduced quality of life.
The study’s development has been supported by the NIHR Guy’s and St Thomas’ Biomedical Research Centre (BRC), and the cell therapy has been manufactured within their own facilities with support from the team at NIHR BRC’s Advanced Therapies Manufacturing platform at Guy’s Hospital.
The MONACO study initially began before the pandemic with the aim of delivering these cells into the legs of patients with peripheral vascular disease to prevent amputation. However, as recovering Covid-19 patients increasingly presented with lung scarring, the team was able to re-purpose the therapy.
“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,” Mr Patel concluded.