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CompletedNCT02611609MUST-ARDSUpdated Nov 20, 2019

A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome

A Phase 1/2 interventional study of MultiStem and MultiStem in Acute Respiratory Distress Syndrome, sponsored by Healios K.K.. Completed at 10 sites in 2 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-11-20.

Sponsored by Healios K.K. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Respiratory Distress Syndrome
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Concurrent illness that shortens life expectancy to less than 6 months
  • Other serious medical or psychiatric illness
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • 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

Interventions

  • BiologicalMultiStem
  • BiologicalMultiStem
  • BiologicalPlacebo
05

What researchers measure

Primary outcomes

  1. Frequency of sustained hypoxemia or hypotension

    Time frame: 4 hours

  2. Suspected Unexpected Serious Adverse Reactions (SUSARs)

    Time frame: 24 hours

Secondary outcomes

  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 outcomes

  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

06

Study locations

10 sites
  • University Hospitals - Cleveland Medical Center
    Cleveland, Ohio 44106, United States
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
  • Queen Elizabeth Hospital
    Birmingham, B15 2TH, United Kingdom
  • Addenbrooke's Hospital
    Cambridge, CB2 0QQ, United Kingdom
  • University College London Hospital
    London, NW12BU, United Kingdom
  • St. Georges Hospital
    London, SW17 0QT, United Kingdom
  • Manchester Royal Infirmary
    Manchester, M139WL, United Kingdom
  • Wythenshawe Hospital
    Manchester, M239LT, United Kingdom
  • John Radcliffe Hospital
    Oxford, OX3 9DU, United Kingdom
07

References and documents

Publications

  • 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. PubMed 34811567 ↗
08

Registry details

Key details

Study ID
NCT02611609
Lead sponsor
Healios K.K.
Collaborators
Athersys Limited, Cell Therapy Catapult
Responsible party
Sponsor
First posted
Nov 23, 2015
Start date
Jan 2016
Primary completion
Sep 2018
Completion
Jul 2019
Last update
Nov 20, 2019

Study contacts

Geoff Bellingan, MD
principal investigator · University College London Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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