NCT05969275: UC-CISSII

Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock

Recruiting now Phase 2 Last updated 5 December 2024

What this trial tests

Phase 2 trial testing Allogeneic umbilical cord-derived human mesenchymal stromal cells in Septic Shock in 296 participants. Currently enrolling.

Timeline

14 February 2024

Primary endpoint
30 September 2026

31 March 2027

Quick facts

Lead sponsor	Ottawa Hospital Research Institute
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	296
Start date	14 February 2024
Primary completion	30 September 2026
Estimated completion	31 March 2027
Sites	2 locations across Canada

Drugs / interventions tested

• Allogeneic umbilical cord-derived human mesenchymal stromal cells — full drug profile →
• Placebo

Conditions studied

• Septic Shock — all drugs for Septic Shock →
• Sepsis — all drugs for Sepsis →
• Pathologic Processes — all drugs for Pathologic Processes →
• Shock — all drugs for Shock →

Sponsor

Ottawa Hospital Research Institute

Who can join

18 and older, any sex, with Septic Shock or Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunotherapy in the context of sepsis-induced immunological dysregulation.
   Wu Y, Wang L, Li Y, Cao Y, et al · · 2024 · cited 11× · PMID 38835773 · DOI 10.3389/fimmu.2024.1391395
2. Efficacy and Safety of Umbilical Cord-Derived Mesenchymal Stromal Cell Therapy in Preclinical Models of Sepsis: A Systematic Review and Meta-analysis.
   Hum C, Tahir U, Mei SHJ, Champagne J, et al · · 2024 · cited 7× · PMID 38381583 · DOI 10.1093/stcltm/szae003
3. Mesenchymal stem/stromal cells as a therapeutic for sepsis: a review on where do we stand?
   Premer C, Hare JM, Yuan SY, Wilson JW. · · 2025 · cited 3× · PMID 40375314 · DOI 10.1186/s13287-025-04371-w
4. Targeting sepsis through inflammation and oxidative metabolism.
   Jacob S, Jacob SA, Thoppil J. · · 2025 · cited 3× · PMID 40060738 · DOI 10.5492/wjccm.v14.i1.101499
5. Advancing cell-based therapy in sepsis: An anesthesia outlook.
   Ye H, Zou X, Fang X. · · 2024 · cited 2× · PMID 38708689 · DOI 10.1097/cm9.0000000000003097
6. Mesenchymal stem cells and the central nervous system: historical perspectives and future directions.
   Mazurek CY, Kaniuk JK, Ahuja CS. · · 2026 · PMID 41809632 · DOI 10.3389/fnmol.2026.1742864
7. Mesenchymal stem cells in sepsis-induced organ dysfunction: mechanisms and therapeutic potential.
   Yang T, Xu X, An J, Li B, et al · · 2025 · PMID 41194123 · DOI 10.1186/s13287-025-04752-1
8. Sepsis: the evolution of molecular pathogenesis concepts and clinical management
   Feng Z, Wang L, Yang J, Li T, et al · · 2025