MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome
Healios K.K.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 18 years of age or older AND 2. Received at least 3 units of any blood product in any hour before Shock Trauma Intensive Care Unit (STICU) arrival AND 3. Survived to initial ICU arrival AND 4. Initial hemostasis has been achieved, in the opinion of the attending surgeon AND 5. Predicted to survive at least 24 hours after STICU arrival by the attending physician AND 6. Ability to start and complete investigational product infusion within 24 hours after known or estimated time of injury. Exclusion Criteria: 1. Prisoners, defined as those who have been directly admitted…
Interventions
- BiologicalMultiStem
Intravenous Infusion
- BiologicalPlacebo
Intravenous Infusion
Location
- Healios Investigational SiteHouston, Texas