The Cell Therapy Manufacturing Facility at the Ottawa Hospital Research Institute is designed to manufacture state-of-the-art stem and progenitor cell-based therapies for the treatment of acutely or chronically ill patients at The Ottawa Hospital. The facility is a founding member of CellCAN, the Canadian-wide network of cell manufacturing facilities. Through CellCAN, facility members actively participate in the design and execution of multi-center cell-therapy trials as well as the dissemination and implementation of Canadian regulatory guidelines.
The facility is currently the primary manufacturing site for three Health Canada authorized clinical trials:
- Enhanced Angiogenic Cell Therapy – Acute Myocardial Infarction (ENACT-AMI) trial is a phase IIb, double-blind, randomized placebo-controlled trial of genetically transfected autologous endothelial progenitor cells in patients who have experienced a myocardial infarction.
- Cellular Immunotherapy for Septic Shock (CISS) is a phase I dose escalation safety trial of allogeneic mesenchymal stem cell (MSC) obtained from healthy bone marrow donors for the treatment of septic shock
- Mesenchymal Stem Cell Therapy for Canadian Multiple Sclerosis Patients (MESCAMS) is a phase I/II "proof-of-principle" study to examine the feasibility, safety and potential benefit of autologous MSC therapy for inflammatory forms of multiple sclerosis (MS). This is a randomized, double-blind, sham-controlled crossover trial using autologous MSCs to treat MS.
To facilitate the clinical trials, two suites, each with two processing rooms, have been designed and built for cGMP processing which incorporates uniquely designed isolator technology to speed work-flow, limit costs, and increase product safety. The cell manufacturing facilities is operated under the auspices of a qualified director, with personnel trained in aseptic technique.