To investigate the safety and tolerance of a single infusion of ProTrans® in subjects with "severe" respiratory complications associated with pneumonia caused by COVID-19, Influenza A, Metapneumovirus or RSV infection.
The investigators hypothesize that the systemic delivery of WJ-MSCs exerts an anti-inflammatory action and anti-apoptotic effect in the lung of COVID-19, Influenza A, Metapneumovirus or RSV patients. The nature of these cells to immunomodulate both tissue resident and bloodborne immune cells towards a more anti-inflammatory and tolerogenic profile, results in a reduction of tissue-based inflammation within the lung and triggering of repair responses. This clinically culminates in a beneficial action on patients with "severe" respiratory complications associated with pneumonia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Allogeneic Wharton's jelly (WJ) Mesenchymal Stromal Cells
Department of Cardiology, Respiratory medicine and Physiology, Örebro University Hospital
Örebro, Sweden
Safety and tolerance of a single infusion of ProTrans®
Grade 3 or 4 adverse event but not usual in natural course of the disease.
Time frame: 24 months
Effect of ProTrans® -MSC on patient clinical status, including mortality, at day 7
Effect of ProTrans® -MSC on patient clinical status as assessed on the 7-point ordinal scale; 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO) 7. Death.
Time frame: 7 days
Effect of ProTrans® -MSC on patient clinical status, including mortality, at day 15
Effect of ProTrans® -MSC on patient clinical status as assessed on the 7-point ordinal scale; 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death.
Time frame: 15 days
Effect of ProTrans® -MSC on patient clinical status, including mortality, at day 30
Effect of ProTrans® -MSC on patient clinical status as assessed on the 7-point ordinal scale; 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death.
Time frame: 30 days
Time to clinical improvement after ProTrans® - MSC infusion
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Time to clinical improvement of one category from admission on the 7-point ordinal scale after ProTrans® - MSC infusion
Time frame: 30 days
Effect of of ProTrans® -MSC on lung damage
Lung damage examination using imaging techniques (Chest X ray/CT scan /or on doppler ultrasound) when assessed for clinical need up to hospital discharge X ray/CT scan /or on doppler ultrasound) when assessed for clinical need
Time frame: Up to 60 days
Duration of hospitalization and Intensive Care Unit (ICU) stay
Duration of hospitalization and ICU stay
Time frame: Up to 60 days
Kinetics of COVID-19, Influenza A, Metapneumovirus, Respiratory Syncytial Virus (RSV) viral load after ProTrans® -MSC infusion
Quantitative PCR for SARS-CoV, Influenza A, Metapneumovirus, Respiratory Syncytial Virus (RSV) virus in throat swabs (time frame: before MSC infusion on Day 0 and after MSC infusion on day 30)
Time frame: Up to 30 days
Evolution of biological markers of liver, myocardium and inflammation
Evaluation of different biomarker after ProTrans® -MSC infusion
Time frame: Up to 24 months
Tolerance of allogeneic Wharton's jelly (WJ) Mesenchymal Stromal Cells (ProTrans®) for severe COVID-19, Influenza A, Metapneumovirus or RSV respiratory conditions
Investigation of tolerance of Wharton's jelly (WJ) Mesenchymal Stromal Cells (ProTrans®) for treatment of viral respiratory tract infections
Time frame: Up to 24 months