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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 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.

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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

Sponsor

Healios K.K.

6 total trials

What the Registry Record Tells You About NCT02611609

The ClinicalTrials.gov registry entry for NCT02611609 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 366-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (90% lower). The listed sponsor is Healios K.K., which has 6 total studies on file at ClinicalTrials.gov.

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 reports 10 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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