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

Acute Respiratory Distress Syndrome Clinical Trial

— MUST-ARDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02611609
• Other study ID #: B04-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2016
• Est. completion date: July 2019

Study information

• Verified date: November 2019
• Source: Athersys, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Biological:
• MultiStem

• MultiStem

• Placebo

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	St. Georges Hospital	London
United Kingdom	University College London Hospital	London
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	Wythenshawe Hospital	Manchester
United Kingdom	John Radcliffe Hospital	Oxford
United States	University Hospitals - Cleveland Medical Center	Cleveland	Ohio
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Athersys, Inc	Athersys Limited, Cell Therapy Catapult

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in exploratory blood inflammatory markers		Up to 7 days
Other	Changes in exploratory blood immune markers		Up to 7 days
Other	Quality of Life (QoL)		Up to 365 days
Primary	Frequency of sustained hypoxemia or hypotension		4 hours
Primary	Suspected Unexpected Serious Adverse Reactions (SUSARs)		24 hours
Secondary	Frequency of adverse events		Up to 365 days
Secondary	Changes in vital signs		Up to 7 days
Secondary	Changes in blood safety laboratories		Up to 7 days
Secondary	Ventilator-free days		28 days
Secondary	ICU-free days		28 days
Secondary	Total length of hospital stay		28 days
Secondary	All-cause mortality		28 days
Secondary	Changes in levels of oxygenation		Up to 28 days
Secondary	Changes in positive end-expiratory airway pressure		Up to 28 days
Secondary	Changes in respiratory physiologic measures including lung compliance and airway resistance (peak and plateau pressures)		Up to Day 365
Secondary	All-cause mortality		Up to Day 365