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Table 2 Inclusion and exclusion criteria for START

From: Design and implementation of the START (STem cells for ARDS Treatment) trial, a phase 1/2 trial of human mesenchymal stem/stromal cells for the treatment of moderate-severe acute respiratory distress syndrome

Inclusion criteria Exclusion criteria
Patients will be eligible for inclusion if they meet all of the below criteria. Criteria 1 to 3 must all be present within a 24-hour time period and at the time of enrollment: 1. Age younger than 18 years
1. A need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio < 200 with at least 8 cmH2O positive end-expiratory airway pressure (PEEP) 2. Greater than 96 hours since first meeting ARDS criteria per the Berlin definition [19]
2. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph, and 3. Pregnant or breast-feeding
No clinical evidence of left atrial hypertension, or if measured, a Pulmonary Arterial Occlusion Pressure (PAOP) less than or equal to 18 mmHg 4. Prisoner
  5. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last two years
  6. Any other irreversible disease or condition for which six-month mortality is estimated to be greater than 50%
  7. Moderate to severe liver failure (Childs-Pugh Score > 12)
  8. Severe chronic respiratory disease with a PaCO2 > 50 mmHg or the use of home oxygen
  9. Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest).
  10. Major trauma in the prior five days
  11. Lung transplant patient
  12. No consent/inability to obtain consent
  13. Moribund patient not expected to survive 24 hours
  14. WHO Class III or IV pulmonary hypertension [27]
  15. Documented deep venous thrombosis or pulmonary embolism within past three months
  16. No arterial line/no intent to place an arterial line
  17. No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol
  18. Currently receiving extracorporeal life support or high-frequency oscillatory ventilation