A Study to Collect Bone Marrow for Process Development and Production of BM-MSC to Treat Severe COVID19 Pneumonitis (COMET20d)
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|ClinicalTrials.gov Identifier: NCT04397471|
Recruitment Status : Not yet recruiting
First Posted : May 21, 2020
Last Update Posted : May 21, 2020
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.
|Condition or disease||Intervention/treatment|
|Healthy Volunteers for Bone Marrow Donation||Procedure: Bone Marrow Harvest|
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||A Study to Collect Bone Marrow for Process Development and Production of Bone Marrow Mesenchymal Stromal Cells to Treat Severe COVID19 Pneumonitis|
|Estimated Study Start Date :||May 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
A one time only 30-80 mL sample of bone marrow will be collected from both posterior superior iliac crests.
Procedure: Bone Marrow Harvest
Healthy volunteer bone marrow harvest
- Determine feasibility of recruiting healthy volunteers in a clinically useful timeframe. [ Time Frame: 3 or more participants recruited in 1 month ]Successful identification of healthy volunteers in acceptable timeframe (i.e. within days) to donate bone marrow.
- Manufacture a cell-based product suitable for clinical use [ Time Frame: Successfully opening the next phase of the trial in approx. 2 months ]Successful manufacture of bone marrow-mesenchymal stromal cells suitable for clinical use
- Establishment of a robust process of production [ Time Frame: Successfully opening the next phase of the trial in approx. 2 months ]Ability to prepare a dossier acceptable to the MHRA. Success will achieved if the dossier is deemed acceptable.
- Production of stability data to be used in the MHRA dossier for the COMET clinical trial. [ Time Frame: Successfully opening the next phase of the trial in approx. 2 months ]Successful manufacturing of products will be defined initially as the award of a Manufacturers Specials Licence to the CCTL to allow the manufacture of Bone Marrow-Mesenchymal Stromal Cells for compassionate use.
- Production of cell-based products to be administered to COVID-19 patients with severe pneumonitis. [ Time Frame: Successfully opening the next phase of the trial in approx. 2 months ]Successful manufacturing of products will be subsequently defined by production under MA(IMP) licence, allowing for future production under CTIMP and CTA.
- Analysis of cells for understanding production, manufacture and related research. [ Time Frame: Successfully opening the next phase of the trial in approx. 2 months ]Successful manufacturing of products, under MA(IMP) licence will be defined as the availability of Bone Marrow-Mesenchymal Stromal Cells to be used in the context of the COMET20 clinical trial.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397471
|Contact: Purity Bundi, BSc||01223 348094 ext firstname.lastname@example.org|
|Contact: Claire Mather, BSc||01223 email@example.com|
|Cambridge University Hospitals NHS Foundation Trust|
|Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ|
|Contact: Andrew McCaskie, FRCS 01223 336976 firstname.lastname@example.org|
|Contact: Charles Crawley, MD 01223 596280 email@example.com|
|Principal Investigator: Charles Crawley, MD|
|Principal Investigator:||Andrew McCaskie, FRCS||University of Cambridge & Cambridge University Hospitals NHS Foundation Trust|