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Completed

NCT Number: NCT01775774

Human Mesenchymal Stem Cells For Acute Respiratory Distress Syndrome

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Acute Lung Injury Lung Diseases Lung Injury Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California San Francisco Medical Center, San Francisco, California, United States

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About this study

The primary objective of this study is to assess the safety of intravenous infusion of Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) in patients with ARDS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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)
  • Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
  • 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

  • Age less than 18 years
  • Greater than 96 hours since first meeting ARDS criteria per the Berlin definition of ARDS
  • Pregnant or breast-feeding
  • Prisoner
  • Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years
  • Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
  • Moderate to severe liver failure (Childs-Pugh Score > 12)
  • Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen
  • 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).
  • Major trauma in the prior 5 days
  • Lung transplant patient
  • No consent/inability to obtain consent
  • Moribund patient not expected to survive 24 hours
  • WHO Class III or IV pulmonary hypertension
  • Documented deep venous thrombosis or pulmonary embolism within past 3 months
  • No arterial line/no intent to place an arterial line
  • No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol
  • Currently receiving extracorporeal life support (ECLS) or high-frequency oscillatory ventilation (HFOV)

Treatment and study plan

Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells

Biological

Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.

Primary outcomes

  1. Incidence of Pre-specified Infusion Associated Adverse Events

    Time frame: 24 hours

    Any of the following occurring within 6 h of mesenchymal stem-cell infusion:

    • Addition of a third vasopressor or an increase in vasopressor dose greater than or equal to the following:
    • Norepinephrine: 10 μg per min
    • Phenylephrine: 100 μg per min
    • Dopamine: 10 μg/kg per min
    • Epinephrine: 0·1 μg/kg per min
    • Hypoxaemia requiring an increase in the fraction of inspired oxygen of ≥0·2 and increase in positive end-expiratory airway pressure level of 5 cm H2O or more to maintain transcutaneous oxygen saturations in the target range of 88-95%
    • New cardiac arrhythmia requiring cardioversion
    • New ventricular tachycardia, ventricular fi brillation, or asystole
    • A clinical scenario consistent with transfusion incompatibility or transfusion-related infection
    • Cardiac arrest or death within 24 h of mesenchymal stem-cell infusion

Secondary outcomes

  1. Incidence of Severe Adverse Events (SAEs)

    Time frame: Investigators conducted daily assessments for the presence of adverse events (AE) from enrollment through study day 28 or hospital discharge, whichever occurred first.

    The number of participants with a severe adverse event during the study was assessed.

  2. Ventilator Free Days at Study Day 28

    Time frame: time of initiating unassisted breathing to day 28

    Ventilator Free Days (VFDs) to day 28 were defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a subject received assisted breathing at day 27 or died prior to day 28, a value of zero VFDs was given.

  3. Duration of Vasopressor Use (Days)

    Time frame: 28 days

    Days on vasopressor to day 28 after study enrollment

  4. ICU Free Days to Day 28

    Time frame: 28 days after study enrollment

  5. Hospital Survival to Day 60

    Time frame: 60 days after randomization

    The number of subjects alive at study day 60. Those subjects discharged home prior to day 60 were counted as alive at day 60.

  6. Mortality at Hospital Discharge

    Time frame: From study enrollment to Hospital discharge

    The number of patients expired at hospital discharge.

Sponsors and collaborators

Lead sponsor

Michael A. Matthay

Other

Collaborators

  • Massachusetts General Hospital
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Stanford University
  • University of Minnesota
  • University of Pittsburgh

Registry information

Official study title

A Phase 1 Multi-center Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stem Cells for the Treatment of Acute Respiratory Distress Syndrome

Acronym: START

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 25, 2013
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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