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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 : Recruiting
First Posted : April 24, 2020
Last Update Posted : March 10, 2021
Sponsor:
Collaborators:
Citospin
University of Valladolid
Castilla-León Health Service
Hospital del Río Hortega
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Red de Terapia Celular

Brief Summary:
Novel coronavirus COVID-19 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 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 phase I/II, placebo- controlled, randomized MSCs for treatment of severe COVID-19 pneumonia.

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Biological: Mesenchymal Stromal Cells Other: Placebo Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Experimental
Intravenous injection of 1 million MSV cells/Kg in 100 ml of saline
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
Other: Placebo
Intravenous injection of 100 ml saline containing no cells




Primary Outcome Measures :
  1. 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

  2. Rate of mortality [ Time Frame: 28 days ]
    To measure global success


Secondary Outcome Measures :
  1. 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

  2. Proportion of patients who have achieved radiological responses [ Time Frame: 0-28 days ]
    Evaluation of pneumonia changes


Other Outcome Measures:
  1. Blood white cell counts and their subpopulations. [ Time Frame: 0-180 days ]
    Haemogram and cell subpopulations

  2. Cellular markers of inflammation [ Time Frame: 0-180 days ]
    Lymphocyte profiles, CD3, CD19, CD16+CD56, CD4/CD8, Tregs

  3. Cytokines and chemokines in peripheral blood [ Time Frame: 0-180 days ]
    IL-10, IL-6, IP-10, TNF-alpha



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women or men of ≥ 18 years of age
  2. SARS-CoV-2 infection confirmed by molecular testing.
  3. 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:

    1. Respiratory distress.
    2. Respiratory rate (FR) ≥ 30 rpm.
    3. Basal oxygen saturation at rest ≤ 93%.
    4. Arterial partial pressure of oxygen (PaO₂) / inspiratory fraction of oxygen (FiO₂) ≤300mmHg
  4. Consent of the patient or his legal representative for participation in the study.

Exclusion Criteria:

  1. Active tumor disease.
  2. Pregnancy.
  3. Participation in another clinical trial for the same pathology.
  4. Any circumstance that in the researcher's opinion justifies the patient's non-participation in the trial.
  5. Lack of signed consent for participation.

Information from the National Library of Medicine

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


Contacts
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Contact: Julia Barbado, MD,PhD +34 616 73 40 03 jbarbadoa@saludcastillayleon.es
Contact: Rosa Conde, MD, PhD +34 608 21 28 65 rconvi@saludcastillayleon.es

Locations
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Spain
Hospital Universitario Rio Hortega Recruiting
Valladolid, Spain, 47012
Contact: Julia Barbado, MD, PhD    +34 983 420400    jbarbadoa@saludcastillayleon.es   
Contact: Rosa Conde, MD, PhD    +34 983 420400    'Rosa Conde Vicente' <rconvi@saludcastillayleon.es>   
Sponsors and Collaborators
Red de Terapia Celular
Citospin
University of Valladolid
Castilla-León Health Service
Hospital del Río Hortega
Instituto de Salud Carlos III
Investigators
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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
Publications of Results:
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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: March 10, 2021
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Red de Terapia Celular:
COVID-19
Mesenchymal Stromal Cells
MSV
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections