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

This study is currently recruiting participants.
Verified January 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: January 4, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Acute Respiratory Distress Syndrome
Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Multi-center 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:
  • 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 ]

Estimated Enrollment: 9
Study Start Date: July 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.

Detailed Description:

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.

  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.

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775774

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 Medical Center Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Michael A Matthay, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Rosemary Vojnik, BS    (650) 723-7409    rvojnik@stanford.edu   
Principal Investigator: Joseph Eric Levitt, 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         
United States, Pennsylvania
University of Pittsburgh Medical Center Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Michael A. Matthay
Massachusetts General Hospital
Stanford University
University of Pittsburgh
University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Michael A. Matthay, Prinicpal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01775774     History of Changes
Other Study ID Numbers: ARDS MSC 001, 1U01HL108713-01
Study First Received: January 18, 2013
Last Updated: January 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Data and Safety Monitoring Board
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on April 23, 2014