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
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
- Trauma
- Adult Stem Cells
Interventions
- BIOLOGICAL
-
MultiStem
Intravenous Infusion
- BIOLOGICAL
-
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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