NCT05969275 Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock
| NCT ID | NCT05969275 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | Septic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 296 participants |
| Start Date | 2024-02-14 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 296 participants in total. It began in 2024-02-14 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Septic shock is associated with substantial burden in terms of both mortality and morbidity for survivors of this illness. Pre-clinical sepsis studies suggest that mesenchymal stem (stromal) cells (MSCs) modulate inflammation, enhance pathogen clearance and tissue repair and reduce death. Our team has completed a Phase I dose escalation and safety clinical trial that evaluated MSCs in patients with septic shock. The Cellular Immunotherapy for Septic Shock Phase I (CISS) trial established that MSCs appear safe and that a randomized controlled trial (RCT) is feasible. Based on these data, the investigators have planned a phase II RCT (UC-CISS II) at several Canadian academic centres which will evaluate intermediate measures of clinical efficacy (primary outcome), as well as biomarkers, safety, clinical outcome measures, and a health economic analysis (secondary outcomes).
Eligibility Criteria
Inclusion Criteria: A participant must meet all the following inclusion criteria at time of randomization to be eligible: 1. At least 18 years of age AND 2. Requirement for admission to the intensive care unit AND 3. Index admission to the intensive care unit AND 4. Cardiovascular organ failure for at least 1 consecutive hour defined by the requirement of at least 5 mcg/min of norepinephrine or 100 mcg/min of phenylephrine or 0.03 U/min vasopressin AND 5. Clinician impression that cardiovascular organ failure is related to infection AND 6. There is at least 1 other acute organ failure according to modified individual Sequential Organ Failure Assessment Scores within 24 hours of meeting Cardiovascular organ failure defined by: 1. Respiratory failure: invasive or non-invasive mechanical ventilation with a positive end expiratory pressure (PEEP) \>/= 5 cm H2O and a partial pressure of oxygen/fractional inspired oxygen concentration (P/F ratio \</= 200), OR high-flow nasal canula oxygen therapy (minimum total flow rate of 30 lpm and 40% FiO2); OR 2. Hematological failure: platelet count of \</= 100 X 10\^9/L OR 3. Acute kidney injury: acute renal insufficiency with a creatinine of \>/= 200 umol/L, or the requirement for new renal replacement therapy, or for participants with known chronic renal failure but not on dialysis, a 50% increase in their baseline creatinine concentration OR 4. Organ hypoperfusion: a lactate \>/= 4 mmol/L Acute organ failures that meet eligibility criteria must not have been present for greater than 48 hours prior to meeting the eligibility criteria. Exclusion Criteria: Patients will be excluded if they have at least one of the following at time of randomization: 1. Another form of shock (cardiogenic, hypovolemic, obstructive) OR 2. History of known chronic pulmonary hypertension with a WHO functional class of IV OR 3. History of severe chronic pulmonary disease requiring home oxygen OR 4. History of severe chronic cardiac disease including congestive heart failure or valvular dysfunction with a New York Heart Association Functional class IV or severe chronic ischemic heart disease with a Canadian Cardiovascular Society angina class score IV OR 5. History of severe chronic liver disease (Child-Pugh Class C or model for end stage liver disease (MELD) Score \>= 15) OR 6. Malignancy in previous 1 year (excluding resolved non-melanoma skin cancer) OR 7. Treating physician impression that death is imminent within the 12 hours after meeting eligibility criteria OR 8. Pregnant or lactating OR 9. Family or patient not committed to aggressive care
Contact & Investigator
Lauralyn McIntyre, MD
PRINCIPAL INVESTIGATOR
Ottawa Hospital Research Institute
Frequently Asked Questions
Who can join the NCT05969275 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05969275 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05969275 currently recruiting?
Yes, NCT05969275 is actively recruiting participants. Contact the research team at UCCISS@ohri.ca for enrollment information.
Where is the NCT05969275 trial being conducted?
This trial is being conducted at Ottawa, Canada, Ottawa, Canada.
Who is sponsoring the NCT05969275 clinical trial?
NCT05969275 is sponsored by Ottawa Hospital Research Institute. The principal investigator is Lauralyn McIntyre, MD at Ottawa Hospital Research Institute. The trial plans to enroll 296 participants.