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Trial record 4 of 18 for:    Stem cells | ARDS

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
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

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
Enrollment 9
Recruitment Details 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  
Arm/Group Title 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
Hide Arm/Group Description Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Period Title: Overall Study
Started 3 3 3
Completed 3 3 3
Not Completed 0 0 0
Arm/Group Title 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
Hide Arm/Group Description Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts. Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 9 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, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 3 participants 9 participants
58.0
(29 to 86)
58.3
(46 to 67)
48.3
(38 to 55)
54.9
(29 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 9 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 9 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 9 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 3 participants 9 participants
3 3 3 9
APACHE III Score   [1] 
Mean (Full Range)
Unit of measure:  Scores on a scale
Number Analyzed 3 participants 3 participants 3 participants 9 participants
91.7
(62 to 111)
89.7
(64 to 115)
88.3
(54 to 108)
89.9
(54 to 115)
[1]
Measure Description: 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 9 participants
Pneumonia 1 1 2 4
Aspiration 1 2 0 3
Sepsis 0 0 1 1
Pre-eclampsia 1 0 0 1
1.Primary Outcome
Title Incidence of Pre-specified Infusion Associated Adverse Events
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW
Hide Arm/Group Description:
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Overall Number of Participants Analyzed 3 3 3
Measure Type: Number
Unit of Measure: participants
0 0 0
2.Secondary Outcome
Title Incidence of Severe Adverse Events (SAEs)
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW
Hide Arm/Group Description:
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Overall Number of Participants Analyzed 3 3 3
Measure Type: Number
Unit of Measure: participants
2 1 0
3.Secondary Outcome
Title Ventilator Free Days at Study Day 28
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW
Hide Arm/Group Description:
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Overall Number of Participants Analyzed 3 3 3
Median (Full Range)
Unit of Measure: day
18
(0 to 24)
22
(0 to 27)
20
(12 to 26)
4.Secondary Outcome
Title Duration of Vasopressor Use (Days)
Hide Description Days on vasopressor to day 28 after study enrollment
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW
Hide Arm/Group Description:
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Overall Number of Participants Analyzed 3 3 3
Median (Full Range)
Unit of Measure: day
4
(0 to 10)
2
(0 to 3)
0
(0 to 0)
5.Secondary Outcome
Title ICU Free Days to Day 28
Hide Description [Not Specified]
Time Frame 28 days after study enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW
Hide Arm/Group Description:
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Overall Number of Participants Analyzed 3 3 3
Median (Full Range)
Unit of Measure: day
14
(0 to 24)
21
(0 to 26)
18
(9 to 22)
6.Secondary Outcome
Title Hospital Survival to Day 60
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW
Hide Arm/Group Description:
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Overall Number of Participants Analyzed 3 3 3
Measure Type: Number
Unit of Measure: participants
2 2 3
7.Secondary Outcome
Title Mortality at Hospital Discharge
Hide Description The number of patients expired at hospital discharge.
Time Frame From study enrollment to Hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW
Hide Arm/Group Description:
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
Overall Number of Participants Analyzed 3 3 3
Measure Type: Number
Unit of Measure: participants
1 1 0
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 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
Hide Arm/Group Description Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   1/3 (33.33%)   0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Multiorgan failure *  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%) 
Vascular disorders       
Infarcts of kidneys, spleen and brain *  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   1/3 (33.33%)   1/3 (33.33%) 
Hepatobiliary disorders       
Elevated liver function tests *  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism *  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
*
Indicates events were collected by non-systematic assessment
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
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 )
First Submitted: January 18, 2013
First Posted: January 25, 2013
Results First Submitted: December 18, 2015
Results First Posted: August 14, 2017
Last Update Posted: August 14, 2017