MONACO: Monocytes as an Anti-fibrotic treatment after Covid-19 [COVID-19]
Research type
Research Study
Full title
Phase I/II MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic treatment after Covid-19
IRAS ID
289624
Contact name
Ashish Patel
Contact email
Sponsor organisation
King's College London
Eudract number
2020-004689-20
Duration of Study in the UK
2 years, 4 months, 2 days
Research summary
Up to a third of patients who recovered from SARS coronavirus (SARS-CoV) had a 20% decline in lung function with a long term reduction in exercise capacity and SF-36 health status a year after infection. Similar outcomes are now being reported in Covid-19 patients, with pulmonary fibrosis and long term lung function decline being a common feature. There are currently no approved treatments for coronavirus-associated pulmonary fibrosis (or, in fact, fibrosis following other severe respiratory viral infections) and effective treatment strategies are needed as it is correlated with the severity and duration of illness. Much of current research pertaining to Covid-19 is focused on immediate outcomes but new treatments aimed at improving medium to longer term outcomes are needed.
This aim of the MONACO study is to test the safety of a novel autologous cell therapy for the treatment of post Covid-19 lung fibrosis. A type of circulating white blood cell, monocyte, is knows to have anti-inflammatory and tissue remodeling properties. Subsets of these monocytes have been shown to ameliorate lung fibrosis in animal models. We have optimised a method to prime monocytes in culture, following isolation from the blood of patients, to modify their properties into tissue remodeling/anti-fibrotic cells.This is a Phase I/II study of 5 patients under the care of the Interstitial Lung Disease Service at King’s Health Partners who have clinical features lung function decline post Covid-19. They will give their blood (the same amount as a blood donation) and their monocytes manufactured in the Cell Therapy Unit at Guy’s & St Thomas NHS Foundation Trust. These cells will be injected intravenously back into the patient. Follow up will involve assessment for early adverse reactions (e.g. fever), blood test, quality of life questionnaires, imaging of their lungs and lung function tests according to their usual clinical follow-up protocol.
REC name
North East - York Research Ethics Committee
REC reference
21/NE/0029
Date of REC Opinion
20 Jan 2021
REC opinion
Further Information Favourable Opinion