The overall objective of the study is to evaluate the safety and efficacy of MSC therapy combined with best supportive care in hospitalized patients with COVID-19.
This study is a monocentric prospective phase I/II clinical trial, aiming at evaluating the safety and efficacy of 3 intravenous administrations of BM-MSC in 20 patients with severe to critical COVID-19 pneumonia. After signed informed consent, patients will receive 3 infusions of (1.5)-3.0 x106/kg BM-MSC (from the same donor) at 3-4 days interval, in addition to the standard of care for COVID-19 disease. The trial will be open for inclusion for 2 years after initiation. Each patient will be followed for 90 days after inclusion. The total study duration will thus be 2 years and 90 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Bone marrow collection and MSC expansion cultures will be carried out at the Laboratory of Cell and Gene Therapy (LTCG) at the University of Liège as described in IMPD and its SOPs.
CHU de Liège
Liège, Belgium
RECRUITINGTo evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia
To assess the infusional toxicity
Time frame: Day 28
To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia
To assess the number of Adverse events of special interest : Incidence of infections (bacterial, viral, fungal, parasitic) and thrombo-embolic events.
Time frame: Day 28
To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia
Group A (patients not under mechanical ventilation): to determine the pourcentage of patients requiring mechanical ventilation
Time frame: Day 28
To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia
Group B (patients under mechanical ventilation): to determine the vital status (dead/alive)
Time frame: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the clinical status (on a 7-point WHO ordinal scale)
Time frame: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the duration of oxygen therapy and/or mechanical ventilation
Time frame: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
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To assess the length of stay at the intensive care unit and of hospitalization
Time frame: Day 90
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the number of organ failures
Time frame: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the intensity of the inflammatory response
Time frame: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the evolution of coagulation parameter
Time frame: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the presence of Biomarker of lung lesion, repair and scarring
Time frame: Day 28
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the v iral load over the 28 days after inclusion and seroconversion to COVID-19 over the 90 days after inclusion
Time frame: Day 90
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the pulmonary function
Time frame: Day 90
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)
To assess the number of adverse reactions (ARs), ARs grade \> 3, serious adverse events (SAEs), serious ARs (SARs), suspected expected and unexpected SARs (SESARs and SUSARs).
Time frame: Day 90