NCT02611609

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2016

Typical duration for phase_1

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

2.7 years

First QC Date

November 18, 2015

Last Update Submit

November 15, 2019

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

  • Frequency of sustained hypoxemia or hypotension

    4 hours

  • Suspected Unexpected Serious Adverse Reactions (SUSARs)

    24 hours

Secondary Outcomes (11)

  • Frequency of adverse events

    Up to 365 days

  • 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

  • +6 more secondary outcomes

Other Outcomes (3)

  • 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

Study Arms (3)

Cohort 1

EXPERIMENTAL

Low dose MultiStem

Biological: MultiStem

Cohort 2

EXPERIMENTAL

High dose MultiStem

Biological: MultiStem

Cohort 3

EXPERIMENTAL

Highest safe MultiStem dose (from Cohorts 1 and 2) or Placebo

Biological: MultiStemBiological: Placebo

Interventions

MultiStemBIOLOGICAL
Cohort 1
PlaceboBIOLOGICAL
Cohort 3

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Concurrent illness that shortens life expectancy to less than 6 months
  • Other serious medical or psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University Hospitals - Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

University College London Hospital

London, NW12BU, United Kingdom

Location

St. Georges Hospital

London, SW17 0QT, United Kingdom

Location

Manchester Royal Infirmary

Manchester, M139WL, United Kingdom

Location

Wythenshawe Hospital

Manchester, M239LT, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34811567DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Geoff Bellingan, MD

    University College London Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 23, 2015

Study Start

January 1, 2016

Primary Completion

September 1, 2018

Study Completion

July 1, 2019

Last Updated

November 20, 2019

Record last verified: 2019-11

Locations

US(3)GB(7)