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

Healios K.K.1 site in 1 country156 target enrollmentNovember 9, 2020

ConditionsTrauma Adult Stem Cells

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Trauma
Sponsor: Healios K.K.
Enrollment: 156
Locations: 1
Primary Endpoint: A composite of the highest Acute Kidney Injury stage (based on KDIGO guidelines)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 9, 2020

End Date

December 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Healios K.K.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 years of age or older AND
•Received at least 3 units of any blood product in any hour before Shock Trauma Intensive Care Unit (STICU) arrival AND
•Survived to initial ICU arrival AND
•Initial hemostasis has been achieved, in the opinion of the attending surgeon AND
•Predicted to survive at least 24 hours after STICU arrival by the attending physician AND
•Ability to start and complete investigational product infusion within 24 hours after known or estimated time of injury.

Exclusion Criteria

•Prisoners, defined as those who have been directly admitted from a correctional facility.
•Prisoners are excluded because of their vulnerable population status. A free-living individual who is under police observation as a suspect will remain in the study until discharge or incarcerated.
•Pregnant and lactating females. It is unknown how stem cells affect a developing fetus or if they can be found in milk. To protect the safety of developing fetuses and breastfeeding children, pregnant and lactating women will be excluded.
•Have a head injury deemed non-survivable by the trauma or neurosurgery attending. The attending physician may determine futility from a range of injuries/physiological responses. These may include non-survivable TBI (malignant ICP elevation despite maximal therapy with findings of uncal herniation and/or brain dead exam; atlantooccipital dissociation), cardio-pulmonary failure refractory to resuscitation and those patients with an advanced directive that declines resuscitative or organ support therapies.
•Hemodynamically unstable or requiring clinically meaningful escalation of vasopressor dose for blood pressure support (to maintain SBP ≥ 90 mmHg) during the 30 minute period prior to study product thawing/preparation. Clinically meaningful vasopressor dose adjustment defined as ≥ 5 mcg/min increase in norepinephrine dose; ≥ 50 mcg/min increase in phenylephrine dose; ≥ 5 mcg/kg/min increase in dopamine dose; and ≥ 0.05 mcg/kg/min increase in epinephrine dose. If the patient is on vasopressin, investigators will be instructed not to titrate the vasopressin dose during this 30 minute period.
•Greater than 20% total body surface area burns and/or suspected inhalation injury.
•Subjects with large and severe thermal injuries and inhalation injures require a resuscitation approach that is different from current isolated trauma resuscitation strategies. Additionally, in the absence of concomitant severe blunt trauma, these subjects are unlikely to receive blood products in the early resuscitative phase.
•Preexisting chronic kidney disease, defined by prior documented glomerular filtration rate less than 60 mL/min/1.73m2 for 3 months or more. Patients who are unable to communicate their pre-existing conditions will be excluded by Medical Alert bracelets/IDs, stigmata pathognomonic for chronic kidney disease such as presence of dialysis vascular access devices or shunts/markedly elevated BUN/Creatinine, or abdominal incisions consistent with organ transplantation, etc.
•Preexisting chronic liver disease, evidenced by clinical or laboratory examinations consistent with chronic liver disease/failure (Childs A-C), patient or family report, Medical Alert bracelets/IDs or abdominal incisions consistent with organ transplantation, etc.
•Known condition of single kidney or concurrent use of potentially nephrotoxic medications at doses likely to be nephrotoxic

Outcomes

Primary Outcomes

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

Time Frame: Day 30

Secondary Outcomes

Hospital days(Day 30)
ICU days(Day 30)
Mortality(Day 30, Day 90, Day 365)
Incidence of Acute Kidney Injury adjusted for the competing risk of death(Day 30)
Incidence of sepsis, Acute Respiratory Distress Syndrome, Multiple Organ Failure, and Venous Thromboembolism(Day 30)
ventilator-free days(Day 30)