Human Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (START)


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Trial ID: NCT02097641


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).

Official Title

Prospective, Randomized, Multi-center Phase 2 Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) for the Treatment of Acute Respiratory Distress Syndrome (ARDS)

Stanford Investigator(s)

Joseph Levitt, MD, MS
Joseph Levitt, MD, MS

Associate Professor of Medicine (Pulmonary and Critical Care Medicine)


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

   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

   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)


biological: Plasma-Lyte A

biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Rosemary Vojnik