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

NCT04533464 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2024-05-24

No results posted yet for this 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

Interventions

BIOLOGICAL

MultiStem

Intravenous Infusion

BIOLOGICAL

Placebo

Intravenous Infusion

Sponsors & Collaborators

  • Memorial Hermann Hospital

    collaborator OTHER
  • United States Department of Defense

    collaborator FED
  • Healios K.K.

    lead INDUSTRY

Principal Investigators

  • Charles Cox, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04533464 on ClinicalTrials.gov