Efficacy of Infusions of MSC From Wharton Jelly in the SARS-Cov-2 (COVID-19) Related Acute Respir… (NCT04625738) | Clinical Trial Compass
CompletedPhase 2
Efficacy of Infusions of MSC From Wharton Jelly in the SARS-Cov-2 (COVID-19) Related Acute Respiratory Distress Syndrome
France30 participantsStarted 2020-11-06
Plain-language summary
Mesenchymal stem cells (MSCs) are of potential help in acute respiratory distress syndrome (ARDS), due to their anti-inflammatory properties.
The investigators will analyze the effect of 3 iterative infusions of ex vivo expanded Wharton's Jelly MSCs (total dose 2.10\^6/kg) in patients with ARDS due to COVID19, who require mechanical ventilation.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Man or woman 18 years of age or older
✓. Patient with a biologically confirmed SARS-CoV-2 infection (by positive RT-PCR on a nasopharyngeal sample or any other sample)
✓. Patient with moderate to severe ARDS according to the BERLIN definition defined by a PaO2 / FiO2 ratio \<200 and with endotracheal intubation and under invasive mechanical ventilation
✓. Patient hospitalized in the intensive care unit
✓. Provision of a written informed consent to participate to the study or for whom the consent of a family member or support person has been obtained (if the patient is unable to give consent) or inclusion in an immediate vital emergency if applicable
✓. Any woman of childbearing age with a negative Beta HCG test
✓. Social Security affiliation
Exclusion criteria
✕. Patient under invasive mechanical ventilation for more than 48 hours
✕. Patient with a chronic respiratory disease under oxygen therapy
✕. Patients with a history of Class III or IV pulmonary arterial hypertension (WHO classification)