Healthy Volunteers for Bone Marrow Donation Clinical Trial
Official title:
A Study to Collect Bone Marrow for Process Development and Production of Bone Marrow Mesenchymal Stromal Cells to Treat Severe COVID19 Pneumonitis
The COVID-19 pandemic, commonly referred to as "coronavirus", first began in the city of
Wuhan, China in December 2019. This virus has since spread globally, with infections reported
in nearly every country. COVID-19 targets the body's respiratory system, where infections can
be found in the nose, throat and lungs. The effect of COVID-19 infection is very variable,
where many people might not know that they have been infected and have recovered from
COVID-19. However, COVID-19 infection can cause people to have difficulty breathing. This can
be severe enough to require hospitalisation and potentially intensive care treatment.
While they are being treated in hospital, COVID-19 infected patients can be found to have
inflamed tissue in their lungs (referred to medically as "pneumonitis"). This inflammation is
thought to be caused by their body's immune systems overacting to the infection rather than
the COVID-19 virus itself. By potentially dampening down this overreaction of their immune
system, it is hoped that COVID-19 patients with inflamed lungs have better and quicker chance
to survive.
Mesenchymal stromal cells (MSCs) have been shown to have anti-inflammatory and healing
properties on injured tissue. MSCs have been trialled in various diseases but have not yet
been tested on patients with COVID-19. In this study, the investigators will obtain bone
marrow from healthy volunteers to develop a cell-based treatment for COVID-19-related
pneumonitis. The investigators will also determine whether it is feasible to recruit bone
marrow donors in a clinically useful timeframe to treat COVID-19 patients. A future trial,
COMET20, will use the bone marrow-derived MSCs (BM-MSCs) manufactured in COMET20d to treat
COVID-19 patients suffering with pneumonitis, to determine whether the BMMSCs can reduce the
likelihood for mechanical ventilation and reduce hospitalisation.
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