Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients (AMETHYST)

This is an interventional treatment trial for Septic Shock focused on measuring Sepsis, Bacteria, Septic Shock, Mesenchymal Stromal Cells, Inflammation, Mesenchymal Stem Cells, Infection Read More

Inclusion Criteria:

1. Adult patients age 18 years and older
2. Receipt of appropriate antibiotics for the suspected/confirmed bacterial sepsis as the main diagnosis according to the opinion of the treating critical care staff physician.
3. Refractory hypotension documented within 48 hours prior to enrolment that requires the institution and ongoing use of vasopressor agents (phenylephrine, norepinephrine, vasopressin, epinephrine, or dopamine >5 mcg/kg/min) for at least 3 hours within 24 hours prior to infusion, despite adequate fluid resuscitation in the opinion of the qualified investigator.

4. At least 1 other new organ dysfunction defined by the following:

   1. Renal: Acute kidney injury with creatinine ≥ 150 µmol/L, or ≥ 1.5x the upper limit of normal or the known baseline creatinine, or < 0.5 ml/kg/hr urine output for 6 hours despite adequate fluid resuscitation (patients on chronic hemodialysis or peritoneal dialysis must meet one of the other organ dysfunction criteria)
   2. Respiratory: Need for invasive mechanical ventilation or a P/F ratio < 250
   3. Hematological: Platelets < 100 x10^9/L, or a drop of 50 x10^9/L in the 3 days prior to enrollment
   4. Metabolic Acidosis: Arterial pH < 7.30 in association with base deficit > 5 mmol/L OR a lactate >/= to 3.0 mmol/L

Exclusion Criteria:

1. Pregnant or lactating
2. Currently receiving extracorporeal life support
3. Documented COVID-19 (SARS-CoV2) or influenza infection (confirmed by laboratory testing)
4. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the past year
5. History of severe heart failure with a New York Heart Association Functional Class of III or IV, or severe ischemic heart disease with a Canadian Cardiovascular Society angina class score of III or IV
6. Moderate to severe chronic liver disease (Childs-Pugh Score > 12)
7. Severe chronic respiratory disease with a baseline PaCO2 > 50 mm Hg or the use of home oxygen
8. Documented deep venous thrombosis or pulmonary embolism within the past 3 months
9. Chronic immunosuppression (any chronic immunotherapy including daily oral steroid use >6months)
10. Uncontrolled HIV infection or end stage HIV/AIDS with CD4+ T-cell counts <50 cells/mm^3, history of hepatitis B, untreated hepatitis C, or active tuberculosis
11. Concurrent use of immunomodulatory biologic drugs or TNF-α inhibitors
12. Participation in another interventional study involving an investigational new drug within 30 days prior to enrolment
13. Moribund patient not expected to survive 24 hours
14. Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)