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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
University of California San Francisco Medical Center
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Incidence of Pre-specified Infusion Associated Adverse Events
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
Time frame: 24 hours
Incidence of Severe Adverse Events (SAEs)
The number of participants with a severe adverse event during the study was assessed.
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.
Ventilator Free Days at Study 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.
Time frame: time of initiating unassisted breathing to day 28
Duration of Vasopressor Use (Days)
Days on vasopressor to day 28 after study enrollment
Time frame: 28 days
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ICU Free Days to Day 28
Time frame: 28 days after study enrollment
Hospital Survival to Day 60
The number of subjects alive at study day 60. Those subjects discharged home prior to day 60 were counted as alive at day 60.
Time frame: 60 days after randomization
Mortality at Hospital Discharge
The number of patients expired at hospital discharge.
Time frame: From study enrollment to Hospital discharge