We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Human Mesenchymal Stem Cells For Acute Respiratory Distress Syndrome (START) (START)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02097641
First Posted: March 27, 2014
Last Update Posted: May 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Massachusetts General Hospital
Stanford University
University of Pittsburgh
University of Minnesota - Clinical and Translational Science Institute
Ohio State University
Information provided by (Responsible Party):
Michael A. Matthay, University of California, San Francisco
  Purpose
This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stem Cells infusion in patients with Acute Respiratory Distress Syndrome (ARDS). This study is the extension of the Phase 1 pilot study (NCT01775774). Patients will be randomized to receive Human Mesenchymal Stem Cells infusion or placebo in a 2:1 allocation. Patients will be followed daily for adverse events through day 28, death or hospital discharge, whichever occurs first. Vital status will be collected at 6 and 12 months after study enrollment.

Condition Intervention Phase
Respiratory Distress Syndrome, Adult Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells Biological: Plasma-Lyte A Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Multi-center Phase 2 Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stem Cells for the Treatment of Acute Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by Michael A. Matthay, University of California, San Francisco:

Primary Outcome Measures:
  • Incidence of pre-specified infusion associated events occurring within 6 hours of study infusion [ Time Frame: 6 hours ]
  • Any cardiac arrest or death within 24 hours of study infusion [ Time Frame: 24 hours ]
  • Any unexpected severe adverse events in two groups [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Respiratory efficacy endpoints which include lung injury score, PaO2/FiO2 ratio and oxygenation index at day 3. [ Time Frame: 28 days ]
  • Systemic efficacy endpoints which include SOFA score, ventilator-free days, organ failure free days, mortality, et al. [ Time Frame: 60 days ]
  • Biological efficacy endpoints which includes serial levels of plasma and urine biomarkers. [ Time Frame: 3 days ]

Enrollment: 60
Actual Study Start Date: March 15, 2014
Estimated Study Completion Date: February 9, 2018
Primary Completion Date: March 9, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Human Mesenchymal Stem Cells
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
Placebo Comparator: Plasma-Lyte A
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Biological: Plasma-Lyte A
Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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:

  1. 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)
  2. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
  3. No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.

Exclusion Criteria:

  1. Age less than 18 years
  2. Greater than 96 hours since first meeting ARDS criteria per the Berlin definition of ARDS
  3. Pregnant or breast-feeding
  4. Prisoner
  5. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years
  6. Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
  7. Moderate to severe liver failure (Childs-Pugh Score > 12)
  8. Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen
  9. 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)
  10. Major trauma in the prior 5 days
  11. Lung transplant patient
  12. No consent/inability to obtain consent
  13. Moribund patient not expected to survive 24 hours
  14. WHO Class III or IV pulmonary hypertension
  15. Documented deep venous thrombosis or pulmonary embolism within past 3 months
  16. No arterial line/no intent to place an arterial line
  17. No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol
  18. Currently receiving extracorporeal life support (ECLS) or high-frequency oscillatory ventilation (HFOV)
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02097641


Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Stanford University
Stanford, California, United States, 94305
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota Medical Center
Saint Paul, Minnesota, United States, 55108
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Michael A. Matthay
National Heart, Lung, and Blood Institute (NHLBI)
Massachusetts General Hospital
Stanford University
University of Pittsburgh
University of Minnesota - Clinical and Translational Science Institute
Ohio State University
Investigators
Principal Investigator: Michael A Matthay, MD University of California, San Francisco
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael A. Matthay, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02097641     History of Changes
Other Study ID Numbers: UCSF-hMSC-ARDS-P2
1U01HL108713-01 ( U.S. NIH Grant/Contract )
First Submitted: March 19, 2014
First Posted: March 27, 2014
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Michael A. Matthay, University of California, San Francisco:
Allogeneic Bone Marrow-derived Human Mesenchymal Stem Cells
Acute Respiratory Distress Syndrome

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions