Human Mesenchymal Stem Cells For Acute Respiratory Distress Syndrome
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Intervention: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells
Intervention description: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Respiratory Distress Syndrome; Acute Lung Injury; Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells

Summary:

      This is a Phase 1, open label, dose escalation, multi-center clinical trial of Allogeneic
      Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) for the treatment of Acute
      Respiratory Distress Syndrome (ARDS). The purpose of this study is to assess the safety of
      hMSCs in patients with 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.

        In addition to meeting inclusion criteria, enrollment must occur within 96-hours of first
        meeting ARDS criteria per the Berlin definition of ARDS.

        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. 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)