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NCT04533464 · ClinicalTrials.gov registry record · Phase 2

MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome

A Phase 2 study of Trauma and Adult Stem Cells, sponsored by Healios K.K..

Recruiting
Registry status
Phase 2
Development phase
156
Enrollment target
1
Study location

NCT04533464 is a Phase 2 study of Trauma and Adult Stem Cells that is actively recruiting participants, run by Healios K.K.. The registered enrollment target is 156 participants, below the 305-participant average among 56 other Trauma trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04533464, a Phase 2 study of Trauma and Adult Stem Cells, is actively recruiting participants, sponsored by Healios K.K..

RECRUITING
Registry status
Phase 2
Development phase
156 participants
Enrollment target
1
Study location

Study Summary

Single center, prospective, randomized, double-blind, pragmatic Phase 2 clinical study in severely injured trauma patients within hours of hospitalization who have survived initial resuscitation.

Conditions Studied

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL MultiStem

Study Locations (1)

Texas

  • Healios Investigational Site - Houston

Trial Details

FieldValue
Enrollment Target 156 participants
Start Date 2020-11-09
Est. Completion 2025-12
Phase Phase 2

Sponsor

Healios K.K.

6 total trials

What the Registry Record Tells You About NCT04533464

The ClinicalTrials.gov registry entry for NCT04533464 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 305-participant average among 56 other Trauma trials with a reported enrollment target (49% lower). The listed sponsor is Healios K.K., which has 6 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Trauma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04533464 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT04533464 about?

NCT04533464 is a clinical study titled "MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome". Single center, prospective, randomized, double-blind, pragmatic Phase 2 clinical study in severely injured trauma patients within hours of hospitalization who have survived initial resuscitation.

What is the current status of trial NCT04533464?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 156 participants. The study started on 2020-11-09. Estimated completion is 2025-12.

What conditions does trial NCT04533464 study?

This clinical trial studies the following conditions: Trauma, Adult Stem Cells.

What interventions are being tested in trial NCT04533464?

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

Who is sponsoring clinical trial NCT04533464?

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

Where is trial NCT04533464 being conducted?

This trial has 1 study location across Texas. 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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