Clinical trial NCT02611609: A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome
Official title: A Phase 1/2 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Healios K.K.
Sponsor class: INDUSTRY
Collaborators: name: Athersys Limited
name: Cell Therapy Catapult
First posted: 2015-11-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Frequency of sustained hypoxemia or hypotension
timeFrame: 4 hours
measure: Suspected Unexpected Serious Adverse Reactions (SUSARs)
timeFrame: 24 hours
Secondary outcomes:
measure: Frequency of adverse events
timeFrame: Up to 365 days
measure: Changes in vital signs
timeFrame: Up to 7 days
measure: Changes in blood safety laboratories
timeFrame: Up to 7 days
measure: Ventilator-free days
timeFrame: 28 days
measure: ICU-free days
timeFrame: 28 days
measure: Total length of hospital stay
timeFrame: 28 days
measure: All-cause mortality
timeFrame: 28 days
measure: Changes in levels of oxygenation
timeFrame: Up to 28 days
measure: Changes in positive end-expiratory airway pressure
timeFrame: Up to 28 days
measure: Changes in respiratory physiologic measures including lung compliance and airway resistance (peak and plateau pressures)
timeFrame: Up to Day 365
measure: All-cause mortality
timeFrame: Up to Day 365
Other outcomes:
measure: Changes in exploratory blood inflammatory markers
timeFrame: Up to 7 days
measure: Changes in exploratory blood immune markers
timeFrame: Up to 7 days
measure: Quality of Life (QoL)
timeFrame: Up to 365 days
Locations:
city: Cleveland
country: United States
facility: University Hospitals - Cleveland Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: London
country: United Kingdom
facility: St. Georges Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: University College London Hospital
name: Geoff Bellingan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bellingan G, Jacono F, Bannard-Smith J, Brealey D, Meyer N, Thickett D, Young D, Bentley A, McVerry BJ, Wunderink RG, Doerschug KC, Summers C, Rojas M, Ting A, Jenkins ED. Safety and efficacy of multipotent adult progenitor cells in acute respiratory distress syndrome (MUST-ARDS): a multicentre, randomised, double-blind, placebo-controlled phase 1/2 trial. Intensive Care Med. 2022 Jan;48(1):36-44. doi: 10.1007/s00134-021-06570-4. Epub 2021 Nov 23.