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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

Tracking Information
First Submitted Date  ICMJE November 18, 2015
First Posted Date  ICMJE November 23, 2015
Last Update Posted Date November 20, 2019
Study Start Date  ICMJE January 2016
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
  • Frequency of sustained hypoxemia or hypotension [ Time Frame: 4 hours ]
  • Suspected Unexpected Serious Adverse Reactions (SUSARs) [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
  • Frequency of adverse events [ Time Frame: Up to 365 days ]
  • Changes in vital signs [ Time Frame: Up to 7 days ]
  • Changes in blood safety laboratories [ Time Frame: Up to 7 days ]
  • Ventilator-free days [ Time Frame: 28 days ]
  • ICU-free days [ Time Frame: 28 days ]
  • Total length of hospital stay [ Time Frame: 28 days ]
  • All-cause mortality [ Time Frame: 28 days ]
  • Changes in levels of oxygenation [ Time Frame: Up to 28 days ]
  • Changes in positive end-expiratory airway pressure [ Time Frame: Up to 28 days ]
  • Changes in respiratory physiologic measures including lung compliance and airway resistance (peak and plateau pressures) [ Time Frame: Up to Day 365 ]
  • All-cause mortality [ Time Frame: Up to Day 365 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
  • Frequency of adverse events [ Time Frame: Up to 365 days ]
  • Changes in vital signs [ Time Frame: Up to 7 days ]
  • Changes in blood safety laboratories [ Time Frame: Up to 7 days ]
  • Ventilator-free days [ Time Frame: 28 days ]
  • ICU-free days [ Time Frame: 28 days ]
  • Total length of hospital stay [ Time Frame: 28 days ]
  • All-cause mortality [ Time Frame: 28 days ]
  • Changes in levels of oxygenation [ Time Frame: Up to 7 days ]
  • Changes in positive end-expiratory airway pressure [ Time Frame: Up to 7 days ]
  • Changes in respiratory physiologic measures including lung compliance and airway resistance (peak and plateau pressures) [ Time Frame: Up to Day 365 ]
  • All-cause mortality [ Time Frame: Up to Day 365 ]
Current Other Pre-specified Outcome Measures
 (submitted: November 19, 2015)
  • Changes in exploratory blood inflammatory markers [ Time Frame: Up to 7 days ]
  • Changes in exploratory blood immune markers [ Time Frame: Up to 7 days ]
  • Quality of Life (QoL) [ Time Frame: Up to 365 days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome
Official Title  ICMJE A Phase 1/2 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Respiratory Distress Syndrome
Intervention  ICMJE
  • Biological: MultiStem
  • Biological: Placebo
Study Arms  ICMJE
  • Experimental: Cohort 1
    Low dose MultiStem
    Intervention: Biological: MultiStem
  • Experimental: Cohort 2
    High dose MultiStem
    Intervention: Biological: MultiStem
  • Experimental: Cohort 3
    Highest safe MultiStem dose (from Cohorts 1 and 2) or Placebo
    Interventions:
    • Biological: MultiStem
    • Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2015)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2019
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02611609
Other Study ID Numbers  ICMJE B04-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Athersys, Inc
Study Sponsor  ICMJE Athersys, Inc
Collaborators  ICMJE
  • Athersys Limited
  • Cell Therapy Catapult
Investigators  ICMJE
Principal Investigator: Geoff Bellingan, MD University College London Hospital
PRS Account Athersys, Inc
Verification Date November 2019

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