A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome
NCT ID: NCT02611609
Last Updated: 2019-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2016-01-31
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1
Low dose MultiStem
MultiStem
Cohort 2
High dose MultiStem
MultiStem
Cohort 3
Highest safe MultiStem dose (from Cohorts 1 and 2) or Placebo
MultiStem
Placebo
Interventions
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MultiStem
MultiStem
Placebo
Eligibility Criteria
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Inclusion Criteria
* Able to receive investigational medicinal product within 96 hours of meeting the last of the ARDS diagnosis criterion
Exclusion Criteria
* Other serious medical or psychiatric illness
18 Years
90 Years
ALL
No
Sponsors
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Athersys Limited
INDUSTRY
Cell Therapy Catapult
OTHER
Healios K.K.
INDUSTRY
Responsible Party
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Principal Investigators
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Geoff Bellingan, MD
Role: PRINCIPAL_INVESTIGATOR
University College London Hospital
Locations
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University Hospitals - Cleveland Medical Center
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
University College London Hospital
London, , United Kingdom
St. Georges Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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References
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Bellingan G, Jacono F, Bannard-Smith J, Brealey D, Meyer N, Thickett D, Young D, Bentley A, McVerry BJ, Wunderink RG, Doerschug KC, Summers C, Rojas M, Ting A, Jenkins ED. Safety and efficacy of multipotent adult progenitor cells in acute respiratory distress syndrome (MUST-ARDS): a multicentre, randomised, double-blind, placebo-controlled phase 1/2 trial. Intensive Care Med. 2022 Jan;48(1):36-44. doi: 10.1007/s00134-021-06570-4. Epub 2021 Nov 23.
Other Identifiers
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B04-01
Identifier Type: -
Identifier Source: org_study_id
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