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

NCT ID: NCT02611609

Last Updated: 2019-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1

Low dose MultiStem

Group Type EXPERIMENTAL

MultiStem

Intervention Type BIOLOGICAL

Cohort 2

High dose MultiStem

Group Type EXPERIMENTAL

MultiStem

Intervention Type BIOLOGICAL

Cohort 3

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

Group Type EXPERIMENTAL

MultiStem

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Interventions

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MultiStem

Intervention Type BIOLOGICAL

MultiStem

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Athersys Limited

INDUSTRY

Sponsor Role collaborator

Cell Therapy Catapult

OTHER

Sponsor Role collaborator

Healios K.K.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geoff Bellingan, MD

Role: PRINCIPAL_INVESTIGATOR

University College London Hospital

Locations

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University Hospitals - Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Queen Elizabeth Hospital

Birmingham, , United Kingdom

Site Status

Addenbrooke's Hospital

Cambridge, , United Kingdom

Site Status

University College London Hospital

London, , United Kingdom

Site Status

St. Georges Hospital

London, , United Kingdom

Site Status

Manchester Royal Infirmary

Manchester, , United Kingdom

Site Status

Wythenshawe Hospital

Manchester, , United Kingdom

Site Status

John Radcliffe Hospital

Oxford, , United Kingdom

Site Status

Countries

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United States United Kingdom

References

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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.

Reference Type DERIVED
PMID: 34811567 (View on PubMed)

Other Identifiers

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B04-01

Identifier Type: -

Identifier Source: org_study_id

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