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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-10-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19 Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Both experimental and placebo groups will receive a similar endovenous injection with either cells or placebo, respectively. Blind to participant, investigator and care providers.

Study Groups

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Mesenchymal Stem Cells (MSCs)

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

Group Type EXPERIMENTAL

Mesenchymal Stem Cells (MSCs)

Intervention Type BIOLOGICAL

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

Placebo

Intravenous injection of 100 ml of physiological saline solution containing no cells

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Intravenous injection of 100 ml physiological saline solution containing no cells

Interventions

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Mesenchymal Stem Cells (MSCs)

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

Intervention Type BIOLOGICAL

Placebo

Intravenous injection of 100 ml physiological saline solution containing no cells

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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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 and intubated in the last 48 hours, that meet at least one of these criteria:

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No