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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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:
NCT01775774
First received: January 18, 2013
Last updated: August 14, 2014
Last verified: August 2014

January 18, 2013
August 14, 2014
July 2013
February 2016   (final data collection date for primary outcome measure)
Comparison of treatment adverse event rates between the 1, 5 and 10 million cells per kilogram dose cohorts [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Safety [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Incidence of pre-specified infusion associated events occurring within 6 hours of administration of hMSCs and of unexpected severe adverse events in ARDS patients treated with hMSCs for 7 days.
Complete list of historical versions of study NCT01775774 on ClinicalTrials.gov Archive Site
Not Provided
Safety [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
Unexpected adverse events up to 12 months
Not Provided
Not Provided
 
Human Mesenchymal Stem Cells For Acute Respiratory Distress Syndrome
A Phase 1 Multi-center Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stem Cells for the Treatment of Acute Respiratory Distress Syndrome

This is a Phase 1, open label, dose escalation, multi-center clinical trial of Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) for the treatment of Acute Respiratory Distress Syndrome (ARDS). The purpose of this study is to assess the safety of hMSCs in patients with ARDS.

The primary objective of this study is to assess the safety of intravenous infusion of Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) in patients with ARDS.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Respiratory Distress Syndrome
Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
Experimental: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells
This is a dose-escalation Phase 1 clinical trial with 3 cohorts with 3 subjects/cohort who will receive doses of 1 million cells/kg, 5 million cells/kg, and 10 million cells/kg. We will proceed from the lower dose to the next higher dose if there are no safety concerns for each cohort of 3 patients.
Intervention: Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells
Asmussen S, Ito H, Traber DL, Lee JW, Cox RA, Hawkins HK, McAuley DF, McKenna DH, Traber LD, Zhuo H, Wilson J, Herndon DN, Prough DS, Liu KD, Matthay MA, Enkhbaatar P. Human mesenchymal stem cells reduce the severity of acute lung injury in a sheep model of bacterial pneumonia. Thorax. 2014 Sep;69(9):819-25. doi: 10.1136/thoraxjnl-2013-204980. Epub 2014 Jun 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
69
February 2017
February 2016   (final data collection date for primary outcome measure)

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.

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:

  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)
Both
18 Years and older
No
Contact: Michael A Matthay, MD 415-353-1206 michael.matthay@ucsf.edu
Contact: Hanjing Zhuo, MPH 415-502-7434 hanjing.zhuo@ucsf.edu
United States
 
NCT01775774
ARDS MSC 001, 1U01HL108713-01
Yes
Michael A. Matthay, University of California, San Francisco
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
Not Provided
University of California, San Francisco
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP