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NCT02611609 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Acute Respiratory Distress Syndrome, sponsored by Healios K.K..

Completed
Registry status
Phase 1
Development phase
36
Enrollment target
10
Study locations

NCT02611609: Completed Phase 1 study of Acute Respiratory Distress Syndrome, sponsored by Healios K.K..

NCT02611609 is a Phase 1 study of Acute Respiratory Distress Syndrome that has completed, run by Healios K.K.. The registered enrollment target is 36 participants, below the 366-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (90% lower). The trial reports 10 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02611609, a Phase 1 study of Acute Respiratory Distress Syndrome, has completed, sponsored by Healios K.K..

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target
10
Study locations

Study 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.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL MultiStem

Study Locations (10)

Other

  • Queen Elizabeth Hospital - Birmingham
  • Addenbrooke's Hospital - Cambridge
  • University College London Hospital - London
  • St. Georges Hospital - London
  • Manchester Royal Infirmary - Manchester
  • Wythenshawe Hospital - Manchester
  • John Radcliffe Hospital - Oxford

Pennsylvania

  • Hospital of the University of Pennsylvania - Philadelphia
  • University of Pittsburgh Medical Center - Pittsburgh

Ohio

  • University Hospitals - Cleveland Medical Center - Cleveland

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2016-01
Est. Completion 2019-07
Phase Phase 1
Healios K.K.

6 total trials

What the finished NCT02611609 record still lists

NCT02611609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 366-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (90% lower).

The record links to 1 condition, with Acute Respiratory Distress Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02611609 lists 10 locations in 3 states (Other, Pennsylvania, Ohio).

Frequently Asked Questions

What is clinical trial NCT02611609 about?

NCT02611609 is a clinical study titled "A Phase 1/2 Study to Assess MultiStem® Therapy in 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.

What is the current status of trial NCT02611609?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2016-01. Estimated completion is 2019-07.

What conditions does trial NCT02611609 study?

This clinical trial studies the following conditions: Acute Respiratory Distress Syndrome.

What interventions are being tested in trial NCT02611609?

The interventions under investigation include: Placebo (BIOLOGICAL), MultiStem (BIOLOGICAL).

Who is sponsoring clinical trial NCT02611609?

This trial is sponsored by Healios K.K., which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02611609 being conducted?

This trial has 10 study locations across Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Acute Respiratory Distress Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02611609's enrollment target sits among peer trials

36 23rd of 31 higher than 9 of 31 other Acute Respiratory Distress Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Respiratory Distress Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02611609, the US trial registry maintained by the National Library of Medicine. NCT02611609 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.