Cellular Immunotherapy for Septic Shock. A Phase I Clinical Trial

Area of Science:

• Regenerative Medicine
• Immunology
• Critical Care Medicine

Background:

• Mesenchymal stem cells (MSCs) demonstrate immunomodulatory and tissue-repairing properties in septic animal models.
• Septic shock remains a leading cause of critical illness with significant mortality.

Purpose of the Study:

• To assess the safety and tolerability of escalating doses of MSCs in patients with septic shock.
• To evaluate potential safety signals and cytokine profiles associated with MSC administration.

Main Methods:

• A phase I, dose-escalation trial involving nine participants with septic shock receiving MSCs.
• Three dose cohorts (0.3, 1.0, 3.0 × 10^6 cells/kg) were administered intravenously.
• A control cohort of 21 participants was used for comparison of adverse events and cytokine levels.

Main Results:

• No MSC infusion-associated or serious unexpected adverse events were reported.
• No significant safety concerns or efficacy signals were observed in adverse events or cytokine levels compared to the control group.
• The highest dose tested was 3 × 10^6 cells/kg (250 million cells).

Conclusions:

• Intravenous infusion of allogeneic bone marrow-derived MSCs appears safe in patients with septic shock.
• The study supports further investigation into MSCs as a potential therapy for septic shock.