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

Sponsor
Athersys, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT02611609
Collaborator
Athersys Limited (Industry), Cell Therapy Catapult (Other)
36
Enrollment
10
Locations
3
Arms
42
Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: MultiStem
  • Biological: MultiStem
  • Biological: Placebo
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome
Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

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: MultiStem

Biological: Placebo

Outcome Measures

Primary Outcome Measures

  1. Frequency of sustained hypoxemia or hypotension [4 hours]

  2. Suspected Unexpected Serious Adverse Reactions (SUSARs) [24 hours]

Secondary Outcome Measures

  1. Frequency of adverse events [Up to 365 days]

  2. Changes in vital signs [Up to 7 days]

  3. Changes in blood safety laboratories [Up to 7 days]

  4. Ventilator-free days [28 days]

  5. ICU-free days [28 days]

  6. Total length of hospital stay [28 days]

  7. All-cause mortality [28 days]

  8. Changes in levels of oxygenation [Up to 28 days]

  9. Changes in positive end-expiratory airway pressure [Up to 28 days]

  10. Changes in respiratory physiologic measures including lung compliance and airway resistance (peak and plateau pressures) [Up to Day 365]

  11. All-cause mortality [Up to Day 365]

Other Outcome Measures

  1. Changes in exploratory blood inflammatory markers [Up to 7 days]

  2. Changes in exploratory blood immune markers [Up to 7 days]

  3. Quality of Life (QoL) [Up to 365 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
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:

  • Concurrent illness that shortens life expectancy to less than 6 months

  • Other serious medical or psychiatric illness

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals - Cleveland Medical Center Cleveland Ohio United States 44106
2 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
3 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
4 Queen Elizabeth Hospital Birmingham United Kingdom B15 2TH
5 Addenbrooke's Hospital Cambridge United Kingdom CB2 0QQ
6 University College London Hospital London United Kingdom NW12BU
7 St. Georges Hospital London United Kingdom SW17 0QT
8 Manchester Royal Infirmary Manchester United Kingdom M139WL
9 Wythenshawe Hospital Manchester United Kingdom M239LT
10 John Radcliffe Hospital Oxford United Kingdom OX3 9DU

Sponsors and Collaborators

  • Athersys, Inc
  • Athersys Limited
  • Cell Therapy Catapult

Investigators

  • Principal Investigator: Geoff Bellingan, MD, University College London Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Athersys, Inc
ClinicalTrials.gov Identifier:
NCT02611609
Other Study ID Numbers:
  • B04-01
First Posted:
Nov 23, 2015
Last Update Posted:
Nov 20, 2019
Last Verified:
Nov 1, 2019
Additional relevant MeSH terms:
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome

Study Results

No Results Posted as of Nov 20, 2019