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

A Phase 1/2 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Biological: Placebo; Biological: MultiStem

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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: Placebo; Biological: MultiStem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of sustained hypoxemia or hypotension	4 hours
Suspected Unexpected Serious Adverse Reactions (SUSARs)	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of adverse events	Up to 365 days
Changes in vital signs	Up to 7 days
Changes in blood safety laboratories	Up to 7 days
Ventilator-free days	28 days
ICU-free days	28 days
Total length of hospital stay	28 days
All-cause mortality	28 days
Changes in levels of oxygenation	Up to 28 days
Changes in positive end-expiratory airway pressure	Up to 28 days
Changes in respiratory physiologic measures including lung compliance and airway resistance (peak and plateau pressures)	Up to Day 365
All-cause mortality	Up to Day 365

Other Outcome Measures

Outcome Measure	Time Frame
Changes in exploratory blood inflammatory markers	Up to 7 days
Changes in exploratory blood immune markers	Up to 7 days
Quality of Life (QoL)	Up to 365 days

Collaborators and Investigators

• Sponsor: Athersys, Inc
• Collaborators: Athersys Limited; Cell Therapy Catapult
• Investigators: Principal Investigator: Geoff Bellingan, MD, University College London Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 23, 2015

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: B04-01