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Completed

NCT Number: NCT02611609

A Phase 1/2 Study to Assess MultiStem® Therapy in 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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Queen Elizabeth Hospital, Birmingham, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MultiStem

Biological

Placebo

Biological

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

Sponsors and collaborators

Lead sponsor

Healios K.K.

Industry

Collaborators

  • Athersys Limited
  • Cell Therapy Catapult

Registry information

Official study title

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

Acronym: MUST-ARDS

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Nov 23, 2015
Registry last updated
Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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