MultiStem® for Trauma-Induced Organ Failure

This study is testing MultiStem®, a biological treatment, or a placebo (an inactive substance) in severely injured trauma patients. You might be able to join if you are 18 or older, have received at least 3 units of blood products before arriving at the Shock Trauma Intensive Care Unit (STICU), and your initial bleeding has been controlled. Doctors also need to believe you will survive at least 24 hours after STICU arrival. The main goal is to see if MultiStem® can help prevent or reduce the severity of acute kidney injury (kidney damage) within 30 days after treatment. The current status of this study is unclear.

Study design
This is a Phase 2, single-center study that will randomly assign participants to receive either MultiStem® or a placebo. It is double-blind, meaning neither you nor your doctors will know which treatment you are receiving. The study plans to enroll 156 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Day 30, suggesting follow-up for at least this duration.

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NCT04533464

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

UNKNOWN
PHASE2Ages 18+InterventionalTreatment
Healios K.K.
~156 participants
Updated 2024-05-24 on ClinicalTrials.gov
What's tested:MultiStemPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
A composite of the highest Acute Kidney Injury stage (based on KDIGO guidelines)
Measured over Day 30
Trauma
Adult Stem Cells
1 sites across 1 states
Texas1
  • Charles Cox, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

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  • A composite of the highest Acute Kidney Injury stage (based on KDIGO guidelines)Day 30