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COVID-19 PneumoniaPhase 2MSV-COVIDNCT04361942

Treatment of Severe COVID-19 Pneumonia With Allogeneic Mesenchymal Stem Cells

A Phase 2 study testing Mesenchymal Stem Cells (MSCs) in people with COVID-19 Pneumonia, run by Red de Terapia Celular at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Novel coronavirus disease COVID-19, produced by SARS-CoV-2, has become a health emergency around the world. Since first patients were detected in Wuhan (China), in December 2019, COVID-19 has spread quickly worldwide, being a severe threat to public health. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19 Pneumonia
What is being tested?
Mesenchymal Stem Cells (MSCs)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteSpain
Study dates
1 May 2020to 28 Oct 2021
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women or men of ≥ 18 years of age
  • SARS-CoV-2 infection confirmed by molecular testing.
  • Admitted to the Intensive Care Unit with pneumonia by COVID-19 infection and intubated in the last 48 hours, that meet at least one of these criteria:
  • Respiratory distress.
  • Respiratory rate (RR) ≥ 30 rpm.
  • Basal oxygen saturation at rest ≤ 93%.
  • Arterial partial pressure of oxygen (PaO2) / inspiratory fraction of oxygen (FiO2) ≤ 300 mmHg.
  • Consent of the patient or his/her legal representative for participation in the study.

Who cannot join

  • Active tumor disease.
  • Pregnancy.
  • Participation in another active clinical trial.
  • Any circumstance that in the researcher's opinion justifies the patient's non-participation in the trial.
  • Not consent to participation.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Rio Hortega

    Valladolid, 47012

Other trials in Spain

About this study

Official title: Double Blind, Placebo-controlled, Phase I/II Clinical Trial to Evaluate Safety and Efficacy of Allogeneic Mesenchymal Stem/Stromal Cells MSV-allo for Treatment of Acute Respiratory Failure in Patients With COVID-19 Pneumonia (MSV-COVID)

Novel coronavirus disease COVID-19, produced by SARS-CoV-2, has become a health emergency around the world. Since first patients were detected in Wuhan (China), in December 2019, COVID-19 has spread quickly worldwide, being a severe threat to public health. Fever, dry cough, shortness of breath and breathing distress are the main characteristics of COVID-19 infection. Some patients develop overwhelming lung inflammation and acute respiratory failure, for which there is no specific therapy. Therefore, safe and effective treatment for COVID-19 pneumonia is utterly necessary, mainly in critical cases. Mesenchymal stem/stromal cells (MSCs) have been widely used in the immune-mediated inflammatory diseases. MSCs can regulate both innate and adaptive immunity by suppressing the proliferation, differentiation and activation of different cells. These immunomodulatory properties of MSCs support performance of the double-blind, placebo-controlled, randomized, phase I/II clinical trial to evaluate safety and efficacy of allogeneic MSCs for treatment of severe COVID-19 pneumonia.

Read the detailed description

Novel coronavirus disease COVID-19, produced by SARS-CoV-2, has spread quickly from Wuhan (China) to worldwide. On April 15, 2020, the World Health Organization (WHO) has reported 1.914.916 confirmed cases and 123.010 deaths globally, being a severe threat to public health.

Some patients develop overwhelming lung inflammation and acute respiratory failure. Several reports demonstrated that SARS-CoV-2 specifically recognize the angiotensin I converting ezyme 2 receptor (ACE2) and ACE2-positive cells are infected by the virus. ACE2 receptor is widely present on the human cells surface such as alveolar type II cells and capillary endothelium, among others. SARS-CoV-2 infects cells and stimulates a terrible cytokine storm in the lung followed by edema, dysfunction of the air exchange and acute respiratory distress which may lead to death. Further, once SARS-CoV-2 enters in blood circulation, it can easily spread to some systems and organs, causing significant damage. Under these circumstances, it is reasonable to believe that the inhibition of inflammatory response is the key to treat COVID-19 pneumonia.

Mesenchymal stem/stromal cells (MSCs) have been widely used in the immune-mediated inflammatory diseases. MSCs can regulate both innate and adaptive immunity by suppressing the proliferation, differentiation and activation of different cells. Some studies have shown that MSCs can significantly reduce acute lung injury in mice caused by H9N2 and H5N1 viruses, reducing proinflammatory cytokines and inflammatory cells into the lungs.

These immunomodulatory properties of MSCs support performance of the placebo-controlled, double-blind (neither the participant nor the investigator will know if active drug or placebo is assigned), randomized (assigned by chance), phase I/II clinical trial in which subjects with severe COVID-19 pneumonia will receive either MSCs (1 million cells/kg) or placebo by intravenous injection. The administration of cells will be done only once.

Being tested
Mesenchymal Stem Cells (MSCs), Placebo
Keywords
COVID-19, Mesenchymal Stromal Cells, Mesenchymal Stem Cells, MSV
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesenchymal Stem Cells (MSCs)Biological

    Also called MSV (GMP-compliant MSCs manufactured by IBGM in Valladolid)

    Intravenous injection of 1 million MSCs (MSV cells)/Kg suspended in 100 ml physiological saline solution.

  • PlaceboOther

    Also called Saline

    Intravenous injection of 100 ml physiological saline solution containing no cells

Study groups in NCT04361942
Study groupRoleWhat they receive
Mesenchymal Stem Cells (MSCs)ExperimentalIntravenous injection of 1 million MSCs (MSV cells)/Kg suspended in 100 ml of physiological saline solution.
Receives: Biological: Mesenchymal Stem Cells (MSCs)
PlaceboPlacebo comparatorIntravenous injection of 100 ml of physiological saline solution containing no cells
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients in whom removal of invasive mechanical ventilation (IMV) has been achieved

    Index of therapy success to preserve Intensive Care Unit (ICU) space.

    Measured: 0-7 days

  2. Overall survival

    To measure global success

    Measured: 0-28 days

Secondary outcomes (4)

  1. Complete clinical response

    Proportion of patients over time that meet the weaning criteria, defined as (i) PaO2/FiO2 ≥ 200 mmHg, (ii) mechanical ventilation with PEEP ≤ 8 (only if BMI<30), (iii) mechanical ventilation with FiO2 ≤ 50% and (iv) no continuous relaxation (cisatracurium) or prone maneuvers in the last 24 hours.

    Measured: 0-Event/Loss to follow-up

  2. Complete radiological response

    Proportion of patients over time that show lung images free from opacities or condensations

    Measured: 0-28 days

  3. Radiological improvement of pulmonary images

    Change in the proportion of lung sections affected by opacities/condensations in chest X-ray images

    Measured: 0-5 days

  4. Removal of invasive mechanical ventilation (IMV)

    Proportion of patients over time that reach the event (removal of IMV)

    Measured: 0-28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start1 May 2020
  3. Primary completion28 Oct 2021
  4. Study completion28 Oct 2021

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04361942
Sponsor's protocol ID
TerCel_007
Other IDs
2020-001682-36
Acronym
MSV-COVID
Status last verified
Jan 2024
First submitted
17 Apr 2020
Last updated
2 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Vega A, Martin-Ferrero MA, Del Canto F, Alberca M, Garcia V, Munar A, Orozco L, Soler R, Fuertes JJ, Huguet M, Sanchez A, Garcia-Sancho J. Treatment of Knee Osteoarthritis With Allogeneic Bone Marrow Mesenchymal Stem Cells: A Randomized Controlled Trial. Transplantation. 2015 Aug;99(8):1681-90. doi: 10.1097/TP.0000000000000678.

    PubMed 25822648

  • Noriega DC, Ardura F, Hernandez-Ramajo R, Martin-Ferrero MA, Sanchez-Lite I, Toribio B, Alberca M, Garcia V, Moraleda JM, Sanchez A, Garcia-Sancho J. Intervertebral Disc Repair by Allogeneic Mesenchymal Bone Marrow Cells: A Randomized Controlled Trial. Transplantation. 2017 Aug;101(8):1945-1951. doi: 10.1097/TP.0000000000001484.

    PubMed 27661661

  • Barbado J, Tabera S, Sanchez A, Garcia-Sancho J. Therapeutic potential of allogeneic mesenchymal stromal cells transplantation for lupus nephritis. Lupus. 2018 Nov;27(13):2161-2165. doi: 10.1177/0961203318804922. Epub 2018 Oct 5.

    PubMed 30290717

  • Leng Z, Zhu R, Hou W, Feng Y, Yang Y, Han Q, Shan G, Meng F, Du D, Wang S, Fan J, Wang W, Deng L, Shi H, Li H, Hu Z, Zhang F, Gao J, Liu H, Li X, Zhao Y, Yin K, He X, Gao Z, Wang Y, Yang B, Jin R, Stambler I, Lim LW, Su H, Moskalev A, Cano A, Chakrabarti S, Min KJ, Ellison-Hughes G, Caruso C, Jin K, Zhao RC. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia. Aging Dis. 2020 Mar 9;11(2):216-228. doi: 10.14336/AD.2020.0228. eCollection 2020 Apr.

    PubMed 32257537

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mesenchymal Stem Cells (MSCs) in people with COVID-19 Pneumonia, run by Red de Terapia Celular at 1 site in Spain.

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 5 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: finished, as of the sponsor's last update on 2 Feb 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 Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients in whom removal of invasive mechanical ventilation (IMV) has been achieved (time frame: 0-7 days). 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?

On the ClinicalTrials.gov record for NCT04361942, which also lists 4 linked publications.

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 2 Feb 2024.

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