AllogeneiC Expanded Human MSC Therapy in Patients Recovering From COVID-19 Acute Respiratory Distress Trial

1. Patient > 18 years and ≤ 80 at age at consent

2. Patient must have:

   • Have a laboratory-confirmed COVID-19 diagnosis (nucleic acid-based assay (e.g., RTPCR) to establish the diagnosis of SARS-CoV-2 infection), who recovered from moderate to severe COVID-19 associated ARDS, as determined by Berlin Criteria and been weaned off the ventilator support."
   • Meet the criteria for mild and moderate COVID-19 as described in COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry (Feb 2021).
   • Recovery from moderate to severe ARDS, diagnosed based on Berlin Criteria, within past 7 days.
3. PaO2/FiO2 > 100 to \<200 mmHg with PEEP>5cm H2O
4. Patient or legally authorized representative (LAR) provides written informed consent, except as noted in 21 CFR 50.23
5. Understands and agrees to comply with planned study procedures
6. Available for clinical follow-up for duration of the treatment and follow-up period
7. Woman of childbearing potential must have a negative pregnancy test at admission or within 24 hours before starting treatment
8. Agree not to become pregnant during treatment and for 1 months after receiving treatment
9. Use at least 2 reliable forms of effective contraception, including 1 barrier method, during treatment and for 1 month after the treatment period

Exclusion Criteria:

1. Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen (chronic obstructive pulmonary disease or pulmonary fibrosis)
2. Be an organ transplant recipient
3. ALT/AST ≥ 5 times the upper limit of normal
4. BMI > 40
5. Stage 4 severe kidney disease or requiring dialysis (i.e. eGFR \<30)
6. Anticipated transfer to another hospital that is not a study site within 72 hours
7. Shock or on ECMO
8. Pregnant or nursing
9. On a ventilator at the time of enrollment
10. Have received high dose corticosteroids at doses >20 mg per day (or prednisone equivalent) administered for ≥14 consecutive days in the month prior to study entry.
11. Have been diagnosed with cancer
12. Demonstrated inability to comply with the study procedures