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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of California, San Francisco
Sponsor:
Collaborators:
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:
NCT02097641
First received: March 19, 2014
Last updated: June 18, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: Yes ]
  • Any cardiac arrest or death within 24 hours of study infusion [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Any unexpected severe adverse events in two groups [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Respiratory efficacy endpoints which include lung injury score, PaO2/FiO2 ratio and oxygenation index at day 3. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Systemic efficacy endpoints which include SOFA score, ventilator-free days, organ failure free days, mortality, et al. [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Biological efficacy endpoints which includes serial levels of plasma and urine biomarkers. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02097641

Contacts
Contact: Michael A Matthay, MD 415-353-1206 michael.matthay@ucsf.edu
Contact: Hanjing Zhuo, MPH 415-502-7434 hanjing.zhuo@ucsf.edu

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Michael A Matthay, MD    415-353-1206    michael.matthay@ucsf.edu   
Contact: Hanjing Zhuo, MPH    415-502-7434    hanjing.zhuo@ucsf.edu   
Principal Investigator: Michael A Matthay, MD         
Sub-Investigator: Kathleen D Liu, MD         
Sub-Investigator: Jenny Wilson, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Rosemary Vojnik    650-723-7409    rvojnik@stanford.edu   
Principal Investigator: Joseph E Levitt, MD         
Sub-Investigator: Angela Rogers, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Katherine Cosgrove, RN    617-726-3498    kcosgrove@partners.org   
Principal Investigator: Taylor B Thompson, MD         
Sub-Investigator: Jeanine Wiener-Kronish, MD         
Sub-Investigator: Ed Bajwa, MD         
United States, Minnesota
University of Minnesota Medical Center Active, not recruiting
Saint Paul, Minnesota, United States, 55108
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Julie Parnish    412-624-7441    parnishja@upmc.edu   
Principal Investigator: Michael Donahoe, MD         
Sub-Investigator: Luis Ortiz, MD         
Sponsors and Collaborators
Michael A. Matthay
Massachusetts General Hospital
Stanford University
University of Pittsburgh
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Michael A Matthay, MD University of California, San Francisco
  More Information

No publications provided by University of California, San Francisco

Additional 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
Study First Received: March 19, 2014
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 30, 2014