Treatment of Severe COVID-19 Pneumonia With Allogeneic Mesenchymal Stromal Cells (COVID_MSV) (COVID_MSV)
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ClinicalTrials.gov Identifier: NCT04361942 |
Recruitment Status :
Completed
First Posted : April 24, 2020
Last Update Posted : June 7, 2022
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 Pneumonia | Biological: Mesenchymal Stromal Cells Other: Placebo | Phase 2 |
Novel coronavirus COVID-19 has spread quickly from Wuhan China to worldwide. On 15 April 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 COVID-19 specifically recognized the angiotensin I converting ezyme 2 repector (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. COVID-19 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 COVID-19 enters in blood circulation, it can easy 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 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 virus, reducing proinflammatory cytokines and inflammatory cells into the lungs.
These immunomodulatory properties of MSCs support performance of the Phase I/II, double-blind (neither the participant nor the investigator will know if active drug or placebo is assigned), placebo-controlled, randomized (assigned by chance), in which subjects with severe COVID-19 pneumonia shall be received either MSCs (1 million cells/kg) or placebo by intravenous injection. The administration of cells will be done only once.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Masking Description: | Both experimental and Placebo will receive a similar endovenous injection with either cells or placebo. Blind to participant, investigator ans care providers |
Primary Purpose: | Treatment |
Official Title: | Double Blind, Placebo-controlled, Phase II Trial to Evaluate Safety and Efficacy of Allogenic Mesenchymal Stromal Cells MSV_allo for Treatment of Acute Respiratory Failure in Patients With COVID-19 Pneumonia (COVID_MSV) |
Actual Study Start Date : | May 1, 2020 |
Actual Primary Completion Date : | October 28, 2021 |
Actual Study Completion Date : | October 28, 2021 |

Arm | Intervention/treatment |
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Experimental: Experimental
Intravenous injection of 1 million MSV cells/Kg in 100 ml of saline
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Biological: Mesenchymal Stromal Cells
Intravenous injection of 1 million MSV cells/Kg diluted in 100 ml saline
Other Name: MSV |
Placebo Comparator: Placebo
Intravenous injection of 100 ml of saline containing no cells
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Other: Placebo
Intravenous injection of 100 ml saline containing no cells |
- Proportion of patients who have achieved withdrawal of invasive mechanical ventilation [ Time Frame: 0-7 days ]Index of therapy success to preserve Intensive Care Hospitalization space
- Rate of mortality [ Time Frame: 28 days ]To measure global success
- Proportion of patients who have achieved clinical response [ Time Frame: 0-7days ]Index based in the 4 most relevant symptoms and signs: fever, shortness of bread, %Hemoglobin Saturation and PaO2 / FiO2
- Proportion of patients who have achieved radiological responses [ Time Frame: 0-28 days ]Evaluation of pneumonia changes
- Blood white cell counts and their subpopulations. [ Time Frame: 0-180 days ]Haemogram and cell subpopulations
- Cellular markers of inflammation [ Time Frame: 0-180 days ]Lymphocyte profiles, CD3, CD19, CD16+CD56, CD4/CD8, Tregs
- Cytokines and chemokines in peripheral blood [ Time Frame: 0-180 days ]IL-10, IL-6, IP-10, TNF-alpha

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women or men of ≥ 18 years of age
- SARS-CoV-2 infection confirmed by molecular testing.
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Admitted to the Intensive Care Unit with pneumonia by COVID-19 infection in the last 48 hours, that meet at least one of these criteria:
- Respiratory distress.
- Respiratory rate (FR) ≥ 30 rpm.
- Basal oxygen saturation at rest ≤ 93%.
- Arterial partial pressure of oxygen (PaO₂) / inspiratory fraction of oxygen (FiO₂) ≤300mmHg
- Consent of the patient or his legal representative for participation in the study.
Exclusion Criteria:
- Active tumor disease.
- Pregnancy.
- Participation in another clinical trial for the same pathology.
- Any circumstance that in the researcher's opinion justifies the patient's non-participation in the trial.
- Lack of signed consent for participation.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361942
Spain | |
Hospital Universitario Rio Hortega | |
Valladolid, Spain, 47012 |
Study Chair: | Julia Barbado, MD, PhD | University Hospital Río Hortega, Valladolid, Spain | |
Study Director: | Rosa Conde, MD, PhD | University Hospital Río Hortega, Valladolid, Spain | |
Principal Investigator: | Margarita González-Vallinas, PhD | University of Valladolid |
Responsible Party: | Red de Terapia Celular |
ClinicalTrials.gov Identifier: | NCT04361942 |
Other Study ID Numbers: |
TerCel_007 2020-001682-36 ( EudraCT Number ) |
First Posted: | April 24, 2020 Key Record Dates |
Last Update Posted: | June 7, 2022 |
Last Verified: | June 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Mesenchymal Stromal Cells MSV |
COVID-19 Pneumonia Respiratory Tract Infections Infections Pneumonia, Viral Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |