Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock (NCT05969275)
Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock: A Multi-Center, Double Blind, Phase II Randomized Controlled Trial
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: The Ottawa Hospital (General Campus) — Ottawa, Ontario
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- The Ottawa Hospital (General Campus) — Ottawa, Ontario
- The Ottawa Hospital (Civic Campus) — Ottawa, Ontario
📞 Contact the Study Coordinator
Phone: (613) 737-8899
Email: UCCISS@ohri.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Septic Shock
- Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study — Birmingham, Alabama
- Comparison of Angiotensin II to Standard Dose Vasopressors on Change in Arterial Elastance — Cleveland, Ohio
- Blood Purification for the Treatment of Pathogen Associated Shock — Washington D.C., District of Columbia
- Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock — London, Ontario
- Evaluating Dynamic Arterial Elastance in Septic Shock Patients. — Bogotá,
- Randomized Control Study in REsuscitation of SEpsis Trial — Bogotá, Bogota D.C.
Explore by condition: All Septic Shock clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.