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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MultiStem
MultiStem
Placebo
Sponsored by
Athersys, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals - Cleveland Medical Center
  • Hospital of the University of Pennsylvania
  • University of Pittsburgh Medical Center
  • Queen Elizabeth Hospital
  • Addenbrooke's Hospital
  • University College London Hospital
  • St. Georges Hospital
  • Manchester Royal Infirmary
  • Wythenshawe Hospital
  • John Radcliffe Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

Low dose MultiStem

High dose MultiStem

Highest safe MultiStem dose (from Cohorts 1 and 2) or Placebo

Outcomes

Primary Outcome Measures

Frequency of sustained hypoxemia or hypotension
Suspected Unexpected Serious Adverse Reactions (SUSARs)

Secondary Outcome Measures

Frequency of adverse events
Changes in vital signs
Changes in blood safety laboratories
Ventilator-free days
ICU-free days
Total length of hospital stay
All-cause mortality
Changes in levels of oxygenation
Changes in positive end-expiratory airway pressure
Changes in respiratory physiologic measures including lung compliance and airway resistance (peak and plateau pressures)
All-cause mortality

Full Information

First Posted
November 18, 2015
Last Updated
November 15, 2019
Sponsor
Athersys, Inc
Collaborators
Athersys Limited, Cell Therapy Catapult
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1. Study Identification

Unique Protocol Identification Number
NCT02611609
Brief Title
A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome
Acronym
MUST-ARDS
Official Title
A Phase 1/2 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Athersys, Inc
Collaborators
Athersys Limited, Cell Therapy Catapult

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Low dose MultiStem
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
High dose MultiStem
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Highest safe MultiStem dose (from Cohorts 1 and 2) or Placebo
Intervention Type
Biological
Intervention Name(s)
MultiStem
Intervention Type
Biological
Intervention Name(s)
MultiStem
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Frequency of sustained hypoxemia or hypotension
Time Frame
4 hours
Title
Suspected Unexpected Serious Adverse Reactions (SUSARs)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Frequency of adverse events
Time Frame
Up to 365 days
Title
Changes in vital signs
Time Frame
Up to 7 days
Title
Changes in blood safety laboratories
Time Frame
Up to 7 days
Title
Ventilator-free days
Time Frame
28 days
Title
ICU-free days
Time Frame
28 days
Title
Total length of hospital stay
Time Frame
28 days
Title
All-cause mortality
Time Frame
28 days
Title
Changes in levels of oxygenation
Time Frame
Up to 28 days
Title
Changes in positive end-expiratory airway pressure
Time Frame
Up to 28 days
Title
Changes in respiratory physiologic measures including lung compliance and airway resistance (peak and plateau pressures)
Time Frame
Up to Day 365
Title
All-cause mortality
Time Frame
Up to Day 365
Other Pre-specified Outcome Measures:
Title
Changes in exploratory blood inflammatory markers
Time Frame
Up to 7 days
Title
Changes in exploratory blood immune markers
Time Frame
Up to 7 days
Title
Quality of Life (QoL)
Time Frame
Up to 365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoff Bellingan, MD
Organizational Affiliation
University College London Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals - Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
NW12BU
Country
United Kingdom
Facility Name
St. Georges Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M139WL
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M239LT
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34811567
Citation
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.
Results Reference
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A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome

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