Research using the production of mesenchymal stem cells (MSCs) is expanding—leading to clinically relevant discoveries across therapeutic areas. Led by Dr. David Courtman, Director Biotherapeutics, the Ottawa Hospital Research Institute’s Cell Manufacturing Facility successfully conducted a Phase I clinical trial examining the safety and efficacy of allogeneic bone marrow-derived MSCs as a treatment for patients experiencing septic shock.
In their Phase I trial, freshly cultured allogeneic bone marrow-derived MSCs were dosed into patients with septic shock.1 A single dose was manufactured using the Corning® HYPERFlask® on an as-needed basis. Since dosing was developed on an emergent per-patient basis, researchers were notified of a patient enrollment and had to deliver the dose within 6 hours.
The Challenge? Large-Scale Production of MSCs in a Space-restricted Facility
Larger-phase clinical trials were needed to determine true clinical impact and this required a significant scale-up of MSCs. That is what Courtman and his colleagues tackled next.
Before initiating clinical Phase II studies, the protocol for generating large quantities of MSCs had to be established to reduce end-product variability, minimize production costs, and to ensure sufficient yield to treat multiple patients. Maximizing the yield of viable cells proved challenging in a limited footprint.