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
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Condition or disease | Intervention/treatment | Phase |
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Acute Respiratory Distress Syndrome | Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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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.
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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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Michael A. Matthay, Prinicpal Investigator, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01775774 |
Other Study ID Numbers: |
ARDS MSC 001 1U01HL108713-01 ( U.S. NIH Grant/Contract ) |
First Posted: | January 25, 2013 Key Record Dates |
Results First Posted: | August 14, 2017 |
Last Update Posted: | August 14, 2017 |
Last Verified: | May 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Acute Respiratory Distress Syndrome Acute Lung Injury Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells |
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome Disease Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |