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Status unknownNCT04445454Updated May 9, 2024

Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection

A Phase 1/2 interventional study of Mesenchymal stromal cells in Coronavirus Infection, sponsored by University of Liege. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by University of Liege · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Coronavirus Infection

Keywords

  • mesenchymal stromal cells
03

In context

Coronavirus Infections

952 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.

This study's planned enrollment of 20 is below the median of 110 across 549 interventional studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

University of Liege is the lead sponsor of 250 studies on the registry; 49 are open to participants now.

Browse University of Liege studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

COVID-19 patients Inclusion criteria

  • Male or female patients aged at least 18 years and up to 70 years
  • Diagnosed with microbiologically or radiologically confirmed COVID-19 pneumonia as defined by:
  • Extensive interstitial pneumonia on CT scan, consistent with viral pneumonia, within 10 days prior to randomization
  • And either positive result of COVID-19 PCR test within 14 days prior to inclusion or positive result of SARS-CoV2 PCR or serology within 14 days after inclusion.

  • Requiring oxygen administration (SpO2 ≤ 93% on room air):

    • Group A: in standard or intensive care unit requiring supplemental oxygen
    • Group B: in intensive care unit under mechanical ventilation administered through a tracheal tube, either:
  • for less than or equal to 7 days
  • for 7 to 14 days, with persisting high inflammation (ferritin > 2,000 µg/L; ferritin > 1,000 µg/L and rising; lymphocytes \< 800 with CRP > 70 mg/L and rising or ferritin > 700 µg/L and rising or LDH > 300 UI/L or D-Dimers > 1000 ng/ml), not explained by superinfection. Rising = compared to previous 24H.
  • Written consent of the patient, or - if impossible (clinical condition precluding capacity to consent) - of his/her legal representative, or - if impossible - of an impartial witness such as a physician from a non-participating department or member of the Ethics Committee. Any consent obtained this way shall be documented and confirmed by way of normal consent procedures at the earliest opportunity when the patient has recovered

Exclusion criteria

  • 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
  • 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

Exclusion criteria

  • Any condition not fulfilling inclusion criteria
  • Known allergy to lidocaine
  • Any risk factor for transmissible infectious diseases, in particular HIV
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    MSC therapy for severe COVID-19 infection

    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.

    Biological: Mesenchymal stromal cells

Interventions

  • BiologicalMesenchymal stromal cells

    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.

    Also known as: MSC

06

What researchers measure

Primary outcomes

  1. To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

    To assess the infusional toxicity

    Time frame: Day 28

  2. 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.

    Time frame: Day 28

  3. 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

    Time frame: Day 28

  4. 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)

    Time frame: Day 28

Secondary outcomes

  1. 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)

    Time frame: Day 28

  2. 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

    Time frame: Day 28

  3. 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

    Time frame: Day 90

  4. 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

    Time frame: Day 28

  5. 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

    Time frame: Day 28

  6. 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

    Time frame: Day 28

  7. 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

    Time frame: Day 28

  8. 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

    Time frame: Day 90

  9. To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

    To assess the pulmonary function

    Time frame: Day 90

  10. 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).

    Time frame: Day 90

Other outcomes

  1. To investigate immune modulation

    To determine the FACS analysis of regulatory T-cell (Treg) levels and Treg and Tconv sub-populations

    Time frame: Day 28

  2. To compare the cytotoxic activity of PBMCs from healthy control and COVID-19 patients (divided in responders / non-responders to MSC therapy) against MSCs in vitro

    To assess the cytotoxic activity by MLR

    Time frame: Day 28

07

Study locations

1 of 1 sites recruiting
  • CHU de Liège
    Liège, 4000, Belgium
    • Yves Beguin, MD,PhD · Contact · yves.beguin@chuliege.be · (0032)43667201
    • Benoit Misset, MD,PhD · Sub investigator
    • Nathalie Layios, MD · Sub investigator
    • Bernard Lambermont, MD,PhD · Sub investigator
    • Michel Moutschen, MD,PhD · Sub investigator
    • Gilles Darcis, MD,PhD · Sub investigator
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2020 (actual). Primary completion is estimated for Sep 2024, 51 months after the start.

Of 30 phase 1/2 interventional studies under Coronavirus Infections, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 27. This study's planned 51 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 19, 2020
First posted
Jun 24, 2020
StartActual
Jun 12, 2020
Primary completionEst.
Sep 30, 2024
CompletionEst.
Sep 30, 2024
Last update
May 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04445454
Lead sponsor
University of Liege
Responsible party
Yves Beguin (MD,PhD, University of Liege) — Principal investigator
First posted
Jun 24, 2020
Start date
Jun 12, 2020
Primary completion
Sep 30, 2024 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
May 9, 2024

Study contacts

Yves Beguin, MD,PhD
Contact
yves.beguin@chuliege.be
(0032)43667201
Audrey Janssen
Contact
audrey.janssen@chuliege.be
(0032)43667470
Yves Beguin, MD,PhD
principal investigator · Centre Hospitalier Universitaire de Liege

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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