Canadian Phase 2 Trial • Health Canada Approved
ABOUT UC-MSCs
Preparing MSCs for HULC-2
How MSCs are prepared, tested, and delivered for the HULC-2 clinical trial.
Where do the cells come from & where are they prepared?
The cells are produced under strict quality standards at the Center for Regenerative Therapies Dresden (CRTD), a licensed facility located at the Technische Universität Dresden University of Technology in Dresden, Germany, using processes compliant with Good Manufacturing Practices (GMP).
Quality Control
Throughout this process, scientists perform quality control checks.
Freezing
The MSCs are frozen at a controlled rate and stored at very low temperatures (below -140°C) in liquid nitrogen vapor.
Cell Culture
MSCs multiply over several days in controlled incubators that mimic the body's natural environment.
Isolation
Mesenchymal stromal cells (MSCs) are isolated from an umbilical cord (UC) at a licensed facility in Dresden, Germany.
Shipping
The frozen MSCs are shipped to Canada, where the final product is prepared at the Ottawa Hospital Research Institute's Biotherapeutics Manufacturing Center (BMC) for use in this clinical trial.
The final MSC product is prepared in Canada at the Ottawa Hospital Research Institute's Biotherapeutics Manufacturing Center (BMC), Canada’s leading Good Manufacturing Practices (GMP) facility for cell- and virus-based therapeutics.
Quality Control
Throughout this process, scientists check the cells’ quality in accordance with strict safety and quality standards set by Health Canada.
Administration
The MSCs are mixed with a saline solution and a fresh product is prepared for IV administration to babies in the
clinical trial.
Cell Culture
Scientists carefully grow and expand the cells for 2 to 5 days.