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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
Results First Received: December 18, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Acute Respiratory Distress Syndrome
Intervention: Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This dose-escalation Phase 1 clinical trial with 3 cohorts with 3 subjects/cohort was performed in 7 centers in USA between July 2013 to January 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Human Mesenchymal Stem Cells 1 Million Cells/kg PBW Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Human Mesenchymal Stem Cells 5 Million Cells/kg PBW Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Human Mesenchymal Stem Cells 10 Million Cells/kg PBW Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.

Participant Flow:   Overall Study
    Human Mesenchymal Stem Cells 1 Million Cells/kg PBW   Human Mesenchymal Stem Cells 5 Million Cells/kg PBW   Human Mesenchymal Stem Cells 10 Million Cells/kg PBW
STARTED   3   3   3 
COMPLETED   3   3   3 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Human Mesenchymal Stem Cells 1 Million Cells/kg PBW Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Mesenchymal Stem Cells 5 Million Cells/kg PBW Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Mesenchymal Stem Cells 10 Million Cells/kg PBW Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Total Total of all reporting groups

Baseline Measures
   Human Mesenchymal Stem Cells 1 Million Cells/kg PBW   Mesenchymal Stem Cells 5 Million Cells/kg PBW   Mesenchymal Stem Cells 10 Million Cells/kg PBW   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   3   3   9 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      2  66.7%      2  66.7%      3 100.0%      7  77.8% 
>=65 years      1  33.3%      1  33.3%      0   0.0%      2  22.2% 
Age 
[Units: Years]
Mean (Full Range)
 58.0 
 (29 to 86) 
 58.3 
 (46 to 67) 
 48.3 
 (38 to 55) 
 54.9 
 (29 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      3 100.0%      3 100.0%      1  33.3%      7  77.8% 
Male      0   0.0%      0   0.0%      2  66.7%      2  22.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      0   0.0%      2  66.7%      0   0.0%      2  22.2% 
Not Hispanic or Latino      3 100.0%      1  33.3%      3 100.0%      7  77.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1  33.3%      0   0.0%      0   0.0%      1  11.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
White      2  66.7%      3 100.0%      2  66.7%      7  77.8% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      1  33.3%      1  11.1% 
Region of Enrollment 
[Units: Participants]
       
United States   3   3   3   9 
APACHE III Score [1] 
[Units: Scores on a scale]
Mean (Full Range)
 91.7 
 (62 to 111) 
 89.7 
 (64 to 115) 
 88.3 
 (54 to 108) 
 89.9 
 (54 to 115) 
[1] Acute Physiology and Chronic Health Evaluation III score, a severity-of-disease classification system. Higher score predicts worse clinical outcome. The scale of APACHE III is 0 - 299, where 0 = best outcome and 299 = worst outcome.
Primary cause of ARDS 
[Units: Participants]
       
Pneumonia   1   1   2   4 
Aspiration   1   2   0   3 
Sepsis   0   0   1   1 
Pre-eclampsia   1   0   0   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Pre-specified Infusion Associated Adverse Events   [ Time Frame: 24 hours ]

2.  Secondary:   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. ]

3.  Secondary:   Ventilator Free Days at Study Day 28   [ Time Frame: time of initiating unassisted breathing to day 28 ]

4.  Secondary:   Duration of Vasopressor Use (Days)   [ Time Frame: 28 days ]

5.  Secondary:   ICU Free Days to Day 28   [ Time Frame: 28 days after study enrollment ]

6.  Secondary:   Hospital Survival to Day 60   [ Time Frame: 60 days after randomization ]

7.  Secondary:   Mortality at Hospital Discharge   [ Time Frame: From study enrollment to Hospital discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael A. Matthay, MD
Organization: University of California San Francisco
phone: 415-353-1206
e-mail: michael.matthay@ucsf.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael A. Matthay, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01775774     History of Changes
Other Study ID Numbers: ARDS MSC 001
1U01HL108713-01 ( U.S. NIH Grant/Contract )
Study First Received: January 18, 2013
Results First Received: December 18, 2015
Last Updated: May 2, 2017