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

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Massachusetts General Hospital
Stanford University
University of Pittsburgh
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Michael A. Matthay, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01775774
First received: January 18, 2013
Last updated: May 2, 2017
Last verified: May 2017
January 18, 2013
May 2, 2017
July 2013
February 2014   (Final data collection date for primary outcome measure)
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
Safety [ Time Frame: 7 days ]
Incidence of pre-specified infusion associated events occurring within 6 hours of administration of hMSCs and of unexpected severe adverse events in ARDS patients treated with hMSCs for 7 days.
Complete list of historical versions of study NCT01775774 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • Duration of Vasopressor Use (Days) [ Time Frame: 28 days ]
    Days on vasopressor to day 28 after study enrollment
  • ICU Free Days to Day 28 [ Time Frame: 28 days after study enrollment ]
  • 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.
  • Mortality at Hospital Discharge [ Time Frame: From study enrollment to Hospital discharge ]
    The number of patients expired at hospital discharge.
Safety [ Time Frame: Up to 12 months ]
Unexpected adverse events up to 12 months
Not Provided
Not Provided
 
Human Mesenchymal Stem Cells For Acute Respiratory Distress Syndrome
A Phase 1 Multi-center Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stem Cells for the Treatment of 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.
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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Respiratory Distress Syndrome
Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
Experimental: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells
A dose-escalation with 3 cohorts with 3 subjects/cohort who receive doses of 1, 5 and 10 million cells/kg predicted body weight (PBW). Proceed from lower dose to next higher dose if no safety concerns for each cohort.
Intervention: Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
February 2015
February 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01775774
ARDS MSC 001
1U01HL108713-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
Michael A. Matthay, University of California, San Francisco
Michael A. Matthay
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Massachusetts General Hospital
  • Stanford University
  • University of Pittsburgh
  • University of Minnesota - Clinical and Translational Science Institute
Not Provided
University of California, San Francisco
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP