Human Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (START)
Condition: Respiratory Distress Syndrome, Adult
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Intervention: Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells; Plasma-Lyte A
Intervention description: Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells was administered intravenously over approximately 60-80 minutes.; Plasma-Lyte A placebo was administered intravenously over approximately 60-80 minutes.
Intervention MeSH terms: Plasma-lyte 148
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells; Acute Respiratory Distress Syndrome

Summary:

      This was a Phase 2a, randomized, double-blind, placebo-controlled, multi-center trial to
      assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human
      Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress
      Syndrome (ARDS).
    

Eligibility criteria:

        Inclusion Criteria:

        Patients will be eligible for inclusion if they meet all of the below criteria. Criteria
        1-3 must all be present within a 24-hour time period and at the time of enrollment:

        Acute onset (defined below) of:

          1. A need for positive pressure ventilation by an endotracheal or tracheal tube with a
             PaO2/FiO2 ratio < 200 with at least 8 cm H2O positive end-expiratory airway pressure
             (PEEP)

          2. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph

          3. No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.

        Exclusion Criteria:

          1. Age less than 18 years

          2. Greater than 96 hours since first meeting ARDS criteria per the Berlin definition of
             ARDS

          3. Pregnant or breast-feeding

          4. Prisoner

          5. Presence of any active malignancy (other than non-melanoma skin cancer) that required
             treatment within the last 2 years

          6. Any other irreversible disease or condition for which 6-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 mm Hg 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 5 days

         11. Lung transplant patient

         12. No consent/inability to obtain consent

         13. Moribund patient not expected to survive 24 hours

         14. World Health Organization (WHO) Class III or IV pulmonary hypertension

         15. Documented deep venous thrombosis or pulmonary embolism within past 3 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 (ECLS) or high-frequency oscillatory
             ventilation (HFOV)