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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator
Michael A Matthay

Description

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stem Cells infusion in patients with Acute Respiratory Distress Syndrome (ARDS). This study is the extension of the Phase 1 pilot study (NCT01775774). Patients will be randomized to receive Human Mesenchymal Stem Cells infusion or placebo in a 2:1 allocation. Patients will be followed daily for adverse events through day 28, death or hospital discharge, whichever occurs first. Vital status will be collected at 6 and 12 months after study enrollment.

Official Title

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

Keywords

Respiratory Distress Syndrome, Adult Allogeneic Bone Marrow-derived Human Mesenchymal Stem Cells Acute Respiratory Distress Syndrome Plasma-lyte 148

Eligibility

You can join if…

Open to people ages 18 years and up

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.

You CAN'T join if...

  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)

Locations

  • Stanford University accepting new patients
    Stanford, California, 94305, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Michael A. Matthay
ID
NCT02097641
Phase
Phase 2
Lead Scientist
Michael A Matthay
Study Type
Interventional
Last Updated
November 2016
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