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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
Sponsor:
Collaborators:
Cambridge Cellular Therapies Laboratory
The Evelyn Trust
Information provided by (Responsible Party):
CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
Healthy Volunteer
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




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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
Bone Marrow harvested from healthy donor volunteers to develop and manufacture cell-based therapy for COVID-19 pneumonitis.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adults aged 18-40 years who are negative for mandatory infectious disease markers including current COVID-19 infection.
Criteria

Inclusion Criteria:

  • Have given written informed consent to participate
  • Be aged between 18 and 40 years old
  • Have Eastern Cooperative Oncology Group (ECOG) performance status 0
  • Be negative for mandatory infectious disease markers (IDM) as per World Marrow Donor Association (WMDA) guidelines
  • Present a negative SARS-CoV2 screen
  • Show absence of clinical symptoms of COVID-19 (Not have been in known COVID-19 contact within the previous 14 days, Adherence to national social distancing guidelines for 14 days)
  • Have a BMI <35kg/m^2
  • Women of childbearing potential need a negative pregnancy test (urine or blood) within 7 days prior to the marrow collection

Exclusion Criteria:

  • Any major disease which would represent a contraindication to bone marrow donation based on WMDA guidelines
  • Presence of any previous or active malignancy (other than non-melanoma skin cancer)
  • Any other concurrent severe and/or uncontrolled medical condition
  • Women who are pregnant or breast-feeding
  • Any acute or chronic back complaint
  • Presence of anaesthetic risk factors

Information from the National Library of Medicine

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


Contacts
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Contact: Purity Bundi, BSc 01223 348094 ext 348094 purity.bundi@addenbrookes.nhs.uk
Contact: Claire Mather, BSc 01223 348090 claire.mather@addenbrookes.nhs.uk

Locations
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United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Andrew McCaskie, FRCS    01223 336976    awm41@cam.ac.uk   
Contact: Charles Crawley, MD    01223 596280    charles.crawley@addenbrookes.nhs.uk   
Principal Investigator: Charles Crawley, MD         
Sponsors and Collaborators
CCTU- Cancer Theme
Cambridge Cellular Therapies Laboratory
The Evelyn Trust
Investigators
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Principal Investigator: Andrew McCaskie, FRCS University of Cambridge & Cambridge University Hospitals NHS Foundation Trust
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Responsible Party: CCTU- Cancer Theme, Dr Andrew McCaskie, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04397471    
Other Study ID Numbers: COMET20d
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections