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A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome (MUST-ARDS)

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.
 
ClinicalTrials.gov Identifier: NCT02611609
Recruitment Status : Completed
First Posted : November 23, 2015
Last Update Posted : November 20, 2019
Sponsor:
Collaborators:
Athersys Limited
Cell Therapy Catapult
Information provided by (Responsible Party):
Athersys, Inc

Study Description
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Brief Summary:
A study to examine the safety (and potential efficacy) of the adult stem cell investigational product, MultiStem, in adults who have Acute Respiratory Distress Syndrome (ARDS). The primary hypothesis is that MultiStem will be safe in ARDS patients.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Biological: MultiStem Biological: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome
Study Start Date : January 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
Low dose MultiStem
 Biological: MultiStem
Experimental: Cohort 2
High dose MultiStem
 Biological: MultiStem
Experimental: Cohort 3
Highest safe MultiStem dose (from Cohorts 1 and 2) or Placebo
 Biological: MultiStem
Biological: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of sustained hypoxemia or hypotension [ Time Frame: 4 hours ]
  2. Suspected Unexpected Serious Adverse Reactions (SUSARs) [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Frequency of adverse events [ Time Frame: Up to 365 days ]
  2. Changes in vital signs [ Time Frame: Up to 7 days ]
  3. Changes in blood safety laboratories [ Time Frame: Up to 7 days ]
  4. Ventilator-free days [ Time Frame: 28 days ]
  5. ICU-free days [ Time Frame: 28 days ]
  6. Total length of hospital stay [ Time Frame: 28 days ]
  7. All-cause mortality [ Time Frame: 28 days ]
  8. Changes in levels of oxygenation [ Time Frame: Up to 28 days ]
  9. Changes in positive end-expiratory airway pressure [ Time Frame: Up to 28 days ]
  10. Changes in respiratory physiologic measures including lung compliance and airway resistance (peak and plateau pressures) [ Time Frame: Up to Day 365 ]
  11. All-cause mortality [ Time Frame: Up to Day 365 ]

Other Outcome Measures:
  1. Changes in exploratory blood inflammatory markers [ Time Frame: Up to 7 days ]
  2. Changes in exploratory blood immune markers [ Time Frame: Up to 7 days ]
  3. Quality of Life (QoL) [ Time Frame: Up to 365 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of moderate to severe ARDS, as defined by the Berlin definition, requiring an endotracheal or tracheal tube
  • Able to receive investigational medicinal product within 96 hours of meeting the last of the ARDS diagnosis criterion

Exclusion Criteria:

  • Concurrent illness that shortens life expectancy to less than 6 months
  • Other serious medical or psychiatric illness
Contacts and Locations
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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): NCT02611609


Locations
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United States, Ohio
University Hospitals - Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
University College London Hospital
London, United Kingdom, NW12BU
St. Georges Hospital
London, United Kingdom, SW17 0QT
Manchester Royal Infirmary
Manchester, United Kingdom, M139WL
Wythenshawe Hospital
Manchester, United Kingdom, M239LT
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Athersys, Inc
Athersys Limited
Cell Therapy Catapult
Investigators
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Principal Investigator: Geoff Bellingan, MD University College London Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Athersys, Inc
ClinicalTrials.gov Identifier: NCT02611609    
Other Study ID Numbers: B04-01
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury