Grant: Planning and Dissemination Grant - Institute Community Support

Severe infection with shock (septic shock) in the intensive care unit (ICU) is common accounting for approximately 20% of admissions, of which 20-40% will die. Septic shock is associated with an immensely uncontrolled inflammatory response from the body that is initiated by the infectious organism. Recent studies done in animals with sepsis suggest that the infusion of stem cells balance inflammation, help repair injured organs, clear bacteria and reduce death. Hence, it represents an exciting and promising potential therapy for septic shock. Our team recently completed the first in the World Phase I dose evaluation and safety trial of stem cells (n=9) versus controls (n=21) in 30 patients with septic shock (Cellular Immunotherapy for Septic Shock (CISS Phase I trial)). The CISS Phase I trial results confirmed the optimum dose and that treatment with stem cells is safe. The 1.5 day CISS International Planning Meeting will bring together national and international key stakeholders, including lead septic shock Mesenchymal Stem Cell (MSC) clinical and translational researchers who are planning to conduct MSC sepsis clinical trials, ICU patient partners and public funders. Through structured presentations and facilitated group discussions, the multi-disciplinary group will aim to harmonize MSC sepsis clinical trial protocols and develop consensus on the collection of common endpoints, discuss the design of an individual patient level meta-analysis where study results across the international clinical trials can be pooled together to better look for evidence of significant treatment effects related to MSCs, and identify challenges and solutions to facilitate future Phase III international RCTS of MSCs in septic shock. The outcomes and action items arising from the CISS International Planning Meeting will be published in peer-reviewed journals and presented at major scientific meetings.