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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02611609

Acronym

MUST-ARDS

Enrollment

Registered

2015-11-23

Start date

2016-01-31

Completion date

2019-07-31

Last updated

2019-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

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.

Interventions

BIOLOGICALMultiStem

BIOLOGICALPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Frequency of adverse events	Up to 365 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
Total length of hospital stay	28 days
All-cause mortality	28 days

Other

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

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026