Coronavirus InfectionPhase 1/2NCT04445454
Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection
A Phase 1/2 study testing Mesenchymal stromal cells in people with Coronavirus Infection, run by University of Liege at 1 site in Belgium.
Trial summary
The overall objective of the study is to evaluate the safety and efficacy of MSC therapy combined with best supportive care in hospitalized patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- Mesenchymal stromal cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Jun 2020to 30 Sep 2024
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Ongoing pregnancy. Women of childbearing potential (WOCBP, defined as a premenopausal female capable of becoming pregnant) should use an appropriate method of contraception (oral, injectable, or mechanical contraception; women whose partners have been vasectomized or have received or are utilizing mechanical contraceptive devices).
- Extracorporeal membrane oxygenation
- Limitations to intensity of care
- Life expectancy < 24 hours
- Known allergy to IMP component
- Active secondary infection
Show all 21Show fewer
- Any malignancy (except non-melanoma skin carcinoma) within 2 years before inclusion
- Pre-existing thrombo-embolic pathology
- Signs of an active drug or alcohol dependence, serious current illness, mental illness or any factors which, in the opinion of the Investigator, may interfere with subject's ability to understand and comply with study requirements
- Patients with any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator's judgment, precludes the patient's safe participation in and completion of the study.
- Participation in another clinical trial(use of anti-viral/supportive drugs for COVID-19 infection on a compassionate use basis is not an exclusion criterion).
- MSC donors Inclusion criteria
- Unrelated to the patient
- Male or female
- Age > 18 yrs
- No HLA matching required
- Fulfills generally accepted criteria for allogeneic HSC donation
- Informed consent given by donor
- Any condition not fulfilling inclusion criteria
- Known allergy to lidocaine
- Any risk factor for transmissible infectious diseases, in particular HIV
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU de Liège
Liège, 4000
Yves Beguin, MD,PhD, (0032)43667201, yves.beguin@chuliege.be
Benoit Misset, MD,PhD
About this study
The overall objective of the study is to evaluate the safety and efficacy of MSC therapy combined with best supportive care in hospitalized patients with COVID-19.
Read the detailed description
This study is a monocentric prospective phase I/II clinical trial, aiming at evaluating the safety and efficacy of 3 intravenous administrations of BM-MSC in 20 patients with severe to critical COVID-19 pneumonia.
After signed informed consent, patients will receive 3 infusions of (1.5)-3.0 x106/kg BM-MSC (from the same donor) at 3-4 days interval, in addition to the standard of care for COVID-19 disease.
The trial will be open for inclusion for 2 years after initiation. Each patient will be followed for 90 days after inclusion. The total study duration will thus be 2 years and 90 days.
- Conditions
- Coronavirus Infection
- Being tested
- Mesenchymal stromal cells
- Keywords
- mesenchymal stromal cells
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stromal cellsBiological
Also called MSC
Bone marrow collection and MSC expansion cultures will be carried out at the Laboratory of Cell and Gene Therapy (LTCG) at the University of Liège as described in IMPD and its SOPs.
| Study group | Role | What they receive |
|---|---|---|
| MSC therapy for severe COVID-19 infection | Experimental | After signed informed consent, patients will receive 3 infusions of (1.5)-3.0 x106/kg BM-MSC (from the same donor) at 3-4 days interval, in addition to the standard of care for COVID-19 disease. Receives: Biological: Mesenchymal stromal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia
To assess the infusional toxicity
Measured: Day 28
To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia
To assess the number of Adverse events of special interest : Incidence of infections (bacterial, viral, fungal, parasitic) and thrombo-embolic events.
Measured: Day 28
To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia
Group A (patients not under mechanical ventilation): to determine the pourcentage of patients requiring mechanical ventilation
Measured: Day 28
To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia
Group B (patients under mechanical ventilation): to determine the vital status (dead/alive)
Measured: Day 28
Secondary outcomes (10)
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the clinical status (on a 7-point WHO ordinal scale)
Measured: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the duration of oxygen therapy and/or mechanical ventilation
Measured: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the length of stay at the intensive care unit and of hospitalization
Measured: Day 90
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the number of organ failures
Measured: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the intensity of the inflammatory response
Measured: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the evolution of coagulation parameter
Measured: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the presence of Biomarker of lung lesion, repair and scarring
Measured: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the v iral load over the 28 days after inclusion and seroconversion to COVID-19 over the 90 days after inclusion
Measured: Day 90
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the pulmonary function
Measured: Day 90
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the number of adverse reactions (ARs), ARs grade > 3, serious adverse events (SAEs), serious ARs (SARs), suspected expected and unexpected SARs (SESARs and SUSARs).
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start12 Jun 2020
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a monocentric prospective phase I/II clinical trial, aiming at evaluating the safety and efficacy of 3 intravenous administrations of BM-MSC in 20 patients with severe to critical COVID-19 pneumonia.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yves Beguin, University of Liege
- Investigators
- Yves Beguin, MD,PhD, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445454
- Sponsor's protocol ID
- TJT2012
- Status last verified
- May 2024
- First submitted
- 19 Jun 2020
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gregoire C, Layios N, Lambermont B, Lechanteur C, Briquet A, Bettonville V, Baudoux E, Thys M, Dardenne N, Misset B, Beguin Y. Bone Marrow-Derived Mesenchymal Stromal Cell Therapy in Severe COVID-19: Preliminary Results of a Phase I/II Clinical Trial. Front Immunol. 2022 Jul 4;13:932360. doi: 10.3389/fimmu.2022.932360. eCollection 2022.
PubMed 35860245
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection
- ClinicalTrials.gov ID
- NCT04445454
- Acronym / sponsor ID
- TJT2012
- Conditions
- Coronavirus Infection
- Keywords
- mesenchymal stromal cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 24 Jun 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 overall objective of the study is to evaluate the safety and efficacy of MSC therapy combined with best supportive care in hospitalized patients with COVID-19.
Detailed description
This study is a monocentric prospective phase I/II clinical trial, aiming at evaluating the safety and efficacy of 3 intravenous administrations of BM-MSC in 20 patients with severe to critical COVID-19 pneumonia.
After signed informed consent, patients will receive 3 infusions of (1.5)-3.0 x106/kg BM-MSC (from the same donor) at 3-4 days interval, in addition to the standard of care for COVID-19 disease.
The trial will be open for inclusion for 2 years after initiation. Each patient will be followed for 90 days after inclusion. The total study duration will thus be 2 years and 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a monocentric prospective phase I/II clinical trial, aiming at evaluating the safety and efficacy of 3 intravenous administrations of BM-MSC in 20 patients with severe to critical COVID-19 pneumonia.
| Arm | Type | Receives |
|---|---|---|
| MSC therapy for severe COVID-19 infection | Experimental | Biological: Mesenchymal stromal cellsAfter signed informed consent, patients will receive 3 infusions of (1.5)-3.0 x106/kg BM-MSC (from the same donor) at 3-4 days interval, in addition to the standard of care for COVID-19 disease. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- Ongoing pregnancy. Women of childbearing potential (WOCBP, defined as a premenopausal female capable of becoming pregnant) should use an appropriate method of contraception (oral, injectable, or mechanical contraception; women whose partners have been vasectomized or have received or are utilizing mechanical contraceptive devices).
- Extracorporeal membrane oxygenation
- Limitations to intensity of care
- Life expectancy < 24 hours
- Known allergy to IMP component
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 |
|---|---|---|
| Mesenchymal stromal cellsAlso: MSCBone marrow collection and MSC expansion cultures will be carried out at the Laboratory of Cell and Gene Therapy (LTCG) at the University of Liège as described in IMPD and its SOPs. | Biological | MSC therapy for severe COVID-19 infection |
Primary outcome
To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia
Time frame: Day 28
To assess the infusional toxicity
To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia
Time frame: Day 28
To assess the number of Adverse events of special interest : Incidence of infections (bacterial, viral, fungal, parasitic) and thrombo-embolic events.
To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia
Time frame: Day 28
Group A (patients not under mechanical ventilation): to determine the pourcentage of patients requiring mechanical ventilation
To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia
Time frame: Day 28
Group B (patients under mechanical ventilation): to determine the vital status (dead/alive)
10 secondary outcomes
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
Time frame: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
Time frame: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
Time frame: Day 90
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
Time frame: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
Time frame: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
Time frame: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
Time frame: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
Time frame: Day 90
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
Time frame: Day 90
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
Time frame: Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 35860245Gregoire C, Layios N, Lambermont B, Lechanteur C, Briquet A, Bettonville V, Baudoux E, Thys M, Dardenne N, Misset B, Beguin Y. Bone Marrow-Derived Mesenchymal Stromal Cell Therapy in Severe COVID-19: Preliminary Results of a Phase I/II Clinical Trial. Front Immunol. 2022 Jul 4;13:932360. doi: 10.3389/fimmu.2022.932360. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Coronavirus Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
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.
Yves Beguin, MD,PhD principal investigator
Centre Hospitalier Universitaire de Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesenchymal stromal cells in people with Coronavirus Infection, run by University of Liege at 1 site in Belgium.
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 0 inclusion and 21 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 9 May 2024. 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 Belgium. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yves Beguin, MD,PhD ((0032)43667201, yves.beguin@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia (time frame: Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04445454, which also lists 1 linked publication.
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 9 May 2024.