Actively Recruiting
MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome
Led by Healios K.K. · Updated on 2024-05-24
156
Participants Needed
1
Research Sites
264 weeks
Total Duration
On this page
Sponsors
H
Healios K.K.
Lead Sponsor
M
Memorial Hermann Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Received at least 3 units of any blood product in any hour before ICU arrival
- Survived to initial ICU arrival
- Initial hemostasis achieved as confirmed by the attending surgeon
- Predicted to survive at least 24 hours after ICU arrival
- Ability to start and complete investigational product infusion within 24 hours after injury
You will not qualify if you...
- Prisoners admitted directly from a correctional facility
- Pregnant or lactating females
- Head injury deemed non-survivable by trauma or neurosurgery attending
- Hemodynamically unstable or requiring significant increase in vasopressor dose during 30 minutes before study product preparation
- Greater than 20% total body surface area burns and/or suspected inhalation injury
- Preexisting chronic kidney disease with glomerular filtration rate less than 60 mL/min/1.73m2 for 3 months or more
- Preexisting chronic liver disease based on clinical or laboratory evidence
- Known single kidney or use of nephrotoxic medications at likely nephrotoxic doses
- Known immunodeficient conditions or use of immunosuppressive medications at immunosuppressive doses
- Known allergy to MultiStem, dimethyl sulfoxide, or human serum albumin
- No available intravenous access of at least 22-gauge for exclusive use during infusion
- Clinical condition likely to worsen with intravenous administration of 250 ml crystalloid
- Known Do Not Resuscitate (DNR) status prior to randomization
- Enrolled in another ongoing interventional clinical trial
- Known functional asplenia, prior splenectomy, or trauma related splenic injury precluding enrollment as determined by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Healios Investigational Site
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Charles Cox, MD
CONTACT
J
Jeanette Podbielski, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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