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

Healios K.K.10 sites in 2 countries36 target enrollmentJanuary 2016

ConditionsAcute Respiratory Distress Syndrome

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acute Respiratory Distress Syndrome
Sponsor: Healios K.K.
Enrollment: 36
Locations: 10
Primary Endpoint: Frequency of sustained hypoxemia or hypotension
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

July 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Healios K.K.

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Frequency of sustained hypoxemia or hypotension

Time Frame: 4 hours

Suspected Unexpected Serious Adverse Reactions (SUSARs)

Time Frame: 24 hours

Secondary Outcomes

Total length of hospital stay(28 days)
All-cause mortality(Up to Day 365)
Frequency of adverse events(Up to 365 days)
Changes in vital signs(Up to 7 days)
Ventilator-free days(28 days)
ICU-free days(28 days)
Changes in blood safety laboratories(Up to 7 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)