A Phase 1/2 interventional study of MultiStem and MultiStem in Acute Respiratory Distress Syndrome, sponsored by Healios K.K.. Completed at 10 sites in 2 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-11-20.
Sponsored by Healios K.K. · Phase 1/2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 47 studies in Respiratory Distress Syndrome with a site in United Kingdom — 10 open to participants now, 13 under way, 3 of them phase 3. Respiratory Distress Syndrome · United Kingdom.
Among the 47 studies in Respiratory Distress Syndrome with a site in United Kingdom, this one is the 24th largest by enrollment of the 31 interventional ones that give a count, is one of 3 that started in 2016, is one of 3 in phase 1/2, and was the 12th registered.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
Browse Respiratory Distress Syndrome studies →10 of the 47 studies in Respiratory Distress Syndrome with a site in United Kingdom are open now. Recruiting first, the newest first:
Guy's and St Thomas' NHS Foundation Trust · Sites in United Kingdom
Ages 18–100
Aerogen Pharma Limited · Sites in United Kingdom, United States, Canada
Ages 1 hrs–24 hrs
BioAegis Therapeutics Inc. · Sites in United Kingdom, United States, Belgium and 10 more countries
Ages 18+
King's College Hospital NHS Trust · Sites in United Kingdom
Ages 34 wk–38 wk
Guy's and St Thomas' NHS Foundation Trust · Sites in United Kingdom
Ages 17+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 194 Respiratory Distress Syndrome studies recruiting now, 118 (61%) set no upper age limit and 48 (25%) stop at 75 or younger; 51 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
47 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 9 · Phase 3 8 · Phase 4 2
First in 2003; this study’s year is marked. 3 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is below the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.
Median enrollment 90 across the 31 interventional studies, 132 across the 15 observational. Of the 27 that completed or were terminated, 6 (22%) have results posted.
This tab as a report to print or save as PDF → With an account.
16 of 47 have an industry lead sponsor. The 10 most frequent:
Healios K.K. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Healios K.K. has 2 studies filed under Respiratory Distress Syndrome — fewer than ten, so there is no comparison to draw.
8 of the studies in Respiratory Distress Syndrome with a site in United Kingdom that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06776783Phase 3Aerogen Pharma LimitedSafety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome | 2027-05 |
| NCT06014138Phase 3Guy's and St Thomas' NHS Foundation TrustVolatile Sedation for Patients With the Acute Respiratory Distress Syndrome | 2027-07-31 |
| NCT05624450Phase 3AstraZenecaEfficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen | 2027-11-04 |
| NCT05388708University of MichiganARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND) | 2027-06-30 |
| NCT07580781Guy's and St Thomas' NHS Foundation TrustFeasibility of Protocolised Analgosedation in ECMO | 2027-08-31 |
Add all 8 to your calendar (.ics) → With an account.
Among the 47 studies in Respiratory Distress Syndrome with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Low dose MultiStem
Biological: MultiStem
High dose MultiStem
Biological: MultiStem
Highest safe MultiStem dose (from Cohorts 1 and 2) or Placebo
Biological: MultiStem · Biological: Placebo
Frequency of sustained hypoxemia or hypotension
Time frame: 4 hours
Suspected Unexpected Serious Adverse Reactions (SUSARs)
Time frame: 24 hours
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
Changes in exploratory blood inflammatory markers
Time frame: Up to 7 days
Changes in exploratory blood immune markers
Time frame: Up to 7 days
Quality of Life (QoL)
Time frame: Up to 365 days
The record gives a start of Jan 2016, a primary completion of Sep 2018 and a completion of Jul 2019. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Invimestrocel
Respiratory Distress Syndrome →
Healios K.K.