Healthy Volunteers for Bone Marrow DonationCOMET20dNCT04397471
A Study to Collect Bone Marrow for Process Development and Production of BM-MSC to Treat Severe COVID19 Pneumonitis
An observational study of Healthy Volunteers for Bone Marrow Donation, run by CCTU- Cancer Theme at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers for Bone Marrow Donation
- What is being tested?
- Bone Marrow Harvest
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults aged 18-40 years who are negative for mandatory infectious disease markers including current COVID-19 infection.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
Andrew McCaskie, FRCS, 01223 336976, awm41@cam.ac.uk
Charles Crawley, MD, 01223 596280, charles.crawley@addenbrookes.nhs.uk
About this study
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.
- Being tested
- Bone Marrow Harvest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow HarvestProcedure or surgery
Healthy volunteer bone marrow harvest
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | A one time only 30-80 mL sample of bone marrow will be collected from both posterior superior iliac crests. Receives: Procedure: Bone Marrow Harvest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Successfully opening the next phase of the trial in approx. 2 months
Secondary outcomes (4)
Establishment of a robust process of production
Ability to prepare a dossier acceptable to the MHRA. Success will achieved if the dossier is deemed acceptable.
Measured: 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.
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.
Measured: 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.
Successful manufacturing of products will be subsequently defined by production under MA(IMP) licence, allowing for future production under CTIMP and CTA.
Measured: Successfully opening the next phase of the trial in approx. 2 months
Analysis of cells for understanding production, manufacture and related research.
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.
Measured: Successfully opening the next phase of the trial in approx. 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study startMay 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers for Bone Marrow DonationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CCTU- Cancer Theme
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge Cellular Therapies Laboratory, The Evelyn Trust
- Responsible party
- Sponsor-investigator, CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Andrew McCaskie, FRCS, Principal investigator, University of Cambridge & Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397471
- Sponsor's protocol ID
- COMET20d
- Acronym
- COMET20d
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Collect Bone Marrow for Process Development and Production of Bone Marrow Mesenchymal Stromal Cells to Treat Severe COVID19 Pneumonitis
- ClinicalTrials.gov ID
- NCT04397471
- Acronym / sponsor ID
- COMET20d / COMET20d
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- CCTU- Cancer ThemeUniversity, hospital or other
- Collaborators
- Cambridge Cellular Therapies Laboratory, The Evelyn Trust
- Study start
- May 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | – | Procedure: Bone Marrow HarvestA one time only 30-80 mL sample of bone marrow will be collected from both posterior superior iliac crests. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults aged 18-40 years who are negative for mandatory infectious disease markers including current COVID-19 infection.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow HarvestHealthy volunteer bone marrow harvest | Procedure or surgery | Healthy Volunteer |
Primary outcome
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
4 secondary outcomes
Establishment of a robust process of production
Time frame: 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.
Time frame: 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.
Time frame: Successfully opening the next phase of the trial in approx. 2 months
Analysis of cells for understanding production, manufacture and related research.
Time frame: Successfully opening the next phase of the trial in approx. 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew McCaskie, FRCS principal investigator
University of Cambridge & Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers for Bone Marrow Donation, run by CCTU- Cancer Theme at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Purity Bundi, BSc (01223 348094 ext. 348094, purity.bundi@addenbrookes.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine feasibility of recruiting healthy volunteers in a clinically useful timeframe. (time frame: 3 or more participants recruited in 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.