Acute Respiratory Distress SyndromePhase 1/2MUST-ARDSNCT02611609
A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome
A Phase 1/2 study testing MultiStem in people with Acute Respiratory Distress Syndrome, run by Healios K.K. at 10 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- MultiStem
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jan 2016to Jul 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Concurrent illness that shortens life expectancy to less than 6 months
- Other serious medical or psychiatric illness
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United Kingdom7 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
Addenbrooke's Hospital
Cambridge, CB2 0QQ
University College London Hospital
London, NW12BU
St. Georges Hospital
London, SW17 0QT
Manchester Royal Infirmary
Manchester, M139WL
Wythenshawe Hospital
Manchester, M239LT
John Radcliffe Hospital
Oxford, OX3 9DU
United States3 sites
University Hospitals - Cleveland Medical Center
Cleveland, Ohio, 44106
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Phase 1/2 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome
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.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- MultiStem, Placebo
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultiStemBiological
MultiStemBiological
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Low dose MultiStem Receives: Biological: MultiStem |
| Cohort 2 | Experimental | High dose MultiStem Receives: Biological: MultiStem |
| Cohort 3 | Experimental | Highest safe MultiStem dose (from Cohorts 1 and 2) or Placebo Receives: Biological: MultiStem; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of sustained hypoxemia or hypotension
Measured: 4 hours
Suspected Unexpected Serious Adverse Reactions (SUSARs)
Measured: 24 hours
Secondary outcomes (11)
Frequency of adverse events
Measured: Up to 365 days
Changes in vital signs
Measured: Up to 7 days
Changes in blood safety laboratories
Measured: Up to 7 days
Ventilator-free days
Measured: 28 days
ICU-free days
Measured: 28 days
Total length of hospital stay
Measured: 28 days
All-cause mortality
Measured: 28 days
Changes in levels of oxygenation
Measured: Up to 28 days
Changes in positive end-expiratory airway pressure
Measured: Up to 28 days
Changes in respiratory physiologic measures including lung compliance and airway resistance (peak and plateau pressures)
Measured: Up to Day 365
All-cause mortality
Measured: Up to Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2018
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healios K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Athersys Limited, Cell Therapy Catapult
- Responsible party
- Sponsor
- Investigators
- Geoff Bellingan, MD, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611609
- Sponsor's protocol ID
- B04-01
- Acronym
- MUST-ARDS
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2015
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34811567
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT02611609
- Acronym / sponsor ID
- MUST-ARDS / B04-01
- Conditions
- Acute Respiratory Distress Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Healios K.K.Industry (pharma, biotech, devices)
- Collaborators
- Athersys Limited, Cell Therapy Catapult
- Study start
- Jan 2016
- Primary completion
- Sep 2018 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 23 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: MultiStemLow dose MultiStem |
| Cohort 2 | Experimental | Biological: MultiStemHigh dose MultiStem |
| Cohort 3 | Experimental | Biological: MultiStem, Biological: PlaceboHighest safe MultiStem dose (from Cohorts 1 and 2) or Placebo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Concurrent illness that shortens life expectancy to less than 6 months
- Other serious medical or psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MultiStem | Biological | Cohort 1 |
| MultiStem | Biological | Cohort 2, Cohort 3 |
| Placebo | Biological | Cohort 3 |
Primary outcome
Frequency of sustained hypoxemia or hypotension
Time frame: 4 hours
Suspected Unexpected Serious Adverse Reactions (SUSARs)
Time frame: 24 hours
11 secondary outcomes
Frequency of adverse events
Time frame: Up to 365 days
Changes in vital signs
Time frame: Up to 7 days
Changes in blood safety laboratories
Time frame: Up to 7 days
Ventilator-free days
Time frame: 28 days
ICU-free days
Time frame: 28 days
Total length of hospital stay
Time frame: 28 days
All-cause mortality
Time frame: 28 days
Changes in levels of oxygenation
Time frame: Up to 28 days
Changes in positive end-expiratory airway pressure
Time frame: Up to 28 days
Changes in respiratory physiologic measures including lung compliance and airway resistance (peak and plateau pressures)
Time frame: Up to Day 365
All-cause mortality
Time frame: Up to Day 365
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Derived from this study: PubMed 34811567Bellingan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoff Bellingan, MD principal investigator
University College London Hospitals
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MultiStem in people with Acute Respiratory Distress Syndrome, run by Healios K.K. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of sustained hypoxemia or hypotension (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02611609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.