Human Mesenchymal Stem Cells For Acute Respiratory Distress Syndrome (START)
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|ClinicalTrials.gov Identifier: NCT01775774|
Recruitment Status : Completed
First Posted : January 25, 2013
Results First Posted : August 14, 2017
Last Update Posted : August 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome||Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2015|
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.
Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775774
|United States, California|
|University of California San Francisco Medical Center|
|San Francisco, California, United States, 94143|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|