Strategies for Developing a Stem Cell Therapy and Lessons learned from an Early Phase Trial of an MSC-based Therapy for Septic Shock Patients
Sponsor
The field of mesenchymal stem/stromal cell (MSC) therapy for critically ill patients has been evolving rapidly since the emergence of preclinical studies on the beneficial effect of MSCs in improving survival and organ functions of septic animal models. Results of a Phase 1, dose-escalation safety trial recently completed by Research scientists from Ottawa Hospital Research Institute (OHRI) suggest that MSCs are safe and well tolerated in patients with septic shock. The OHRI team is now pursuing a Phase II randomized controlled trial to continue the safety evaluation and look for signs of efficacy.
In this webinar, OHRI Investigator Dr. Shirley Mei and Senior Scientist Dr. Lauralyn McIntyre will discuss how their team translated a MSC therapy manufacturing process from the preclinical laboratory to a GMP setting, and what considerations were taken to design a first in human trial to examine MSCs for the treatment of septic shock. Corning Field Applications Scientist Dr. Catherine Siler will present tools and process design strategies for achieving consistent and efficient expansion of therapeutic cells, including scale-up and scale-out options and closed system designs.
- Challenges in developing a cell therapy productfor acutely ill patients
- Trial design consideration for assessing safetyof MSC therapy in septic shock
- Lessons learned from cell therapy products usedin our early phase trial
- Process design for consistent and efficientscale up of therapeutic cells
