A Study to Collect Bone Marrow for Process Development and Production of BM-MSC to Treat Severe COVID19 Pneumonitis

NCT04397471 | Unknown

• 1 other identifier: COMET20d
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers for Bone Marrow Donation

Outcome Measures

Primary Outcomes (2)

• Determine feasibility of recruiting healthy volunteers in a clinically useful timeframe.

  Successful identification of healthy volunteers in acceptable timeframe (i.e. within days) to donate bone marrow.

  3 or more participants recruited in 1 month

• Manufacture a cell-based product suitable for clinical use

  Successful manufacture of bone marrow-mesenchymal stromal cells suitable for clinical use

  Successfully opening the next phase of the trial in approx. 2 months

Secondary Outcomes (4)

• Establishment of a robust process of production

  Successfully opening the next phase of the trial in approx. 2 months

• Production of stability data to be used in the MHRA dossier for the COMET clinical trial.

  Successfully opening the next phase of the trial in approx. 2 months

• Production of cell-based products to be administered to COVID-19 patients with severe pneumonitis.

  Successfully opening the next phase of the trial in approx. 2 months

• Analysis of cells for understanding production, manufacture and related research.

  Successfully opening the next phase of the trial in approx. 2 months

Study Arms (1)

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

Interventions

Bone Marrow Harvest PROCEDURE

Healthy volunteer bone marrow harvest

Healthy Volunteer

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CCTU- Cancer Theme: lead
• Cambridge Cellular Therapies Laboratory: collaborator
• The Evelyn Trust: collaborator

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

Study Officials

• Andrew McCaskie, FRCS

  University of Cambridge & Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Purity Bundi, BSc

CONTACT

01223 348094; purity.bundi@addenbrookes.nhs.uk

Claire Mather, BSc

CONTACT

01223 348090; claire.mather@addenbrookes.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Andrew McCaskie

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 21, 2020
• Study Start: May 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 21, 2020

Record last verified: 2020-05

Locations

GB (1)