CTSG April 2018 Update - The bi-annual Cell Therapy Stakeholder Group (CTSG) meeting with Health Canada was held on April 24, 2018. The CTSG was previously expanded to include representation from the Regenerative Medicine Alliance of Canada, including the Stem Cell Network (SCN) and the Ontario Institute of Regenerative Medicine (OIRM), in addition to the usual participation from CellCAN, Centre for Commercialization of Regenerative Medicine (CCRM) and the International Society of Cellular Therapy (ISCT).
6 Agenda items were presented and discussed at this meeting. Approved meeting minutes are available in the CTSG page on CellCAN's Website.
- The first agenda item included an update on the revised Terms of Reference which was discussed at the previous stakeholder meeting in December 2017. Health Canada had reviewed the Terms of References and had suggested that a mechanism be included for additional new members to join the group. The revised Terms of Reference are currently being reviewed by the group and will be shortly finalized and re-submitted to Health Canada.
- Dr. Viswanathan presented an update on discussions on potential policy changes to the New Substance Notification Regulation (Organism) with Environment and Climate Change Canada (ECCC) and the Biologics and Genetics Therapeutics Directorate (BGTD) at an earlier workshop (March 17, 2018 co-organized by CellCAN and BIOTEC Canada). Dr. Viswanathan requested that new draft guidelines on how to complete Schedule 1 of the NSNR (O) be circulated to the stakeholders for further input and comment. Minutes from the March 2018 workshop were being reviewed by BGTD and ECCC and would also be shortly available.
- Dr. Dominici from ISCT presented on behalf of ISCT’s Presidential Task Force on the Use of Unproven Cellular Therapies. He reported that the activities of ISCT’s Presidential Task Force are closely aligned with FDA stance and statement on the need to ensure proper oversight of stem cell therapies and regenerative medicine. Dr. Dominici presented on the activities of the Presidential Task Force and its global campaign to inform the public since 2013. Health Canada commented that it was aware of actions take by the FDA to regulate unproven stem cell therapies and was continuing to communicate its own position regarding cell therapy. Cell Therapy in Canada typically meets the definition of a drug and is therefore regulated under the Food and Drugs Act.
- Patrick Bedford from CCRM asked clarification on regulations for healthcare products vs. healthcare procedures, especially procedures performed using autologous cells. Health Canada re-emphasized that all cell therapy products with limited exceptions meet the definition of drug under the Food and Drug Act and are regulated as such. There is no exemption made for drug products which are prepared at the bedside under the current regulatory framework. Health Canada is open to expanding the Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regs) at its next scheduled review.
- Dr. Cristina Nostro, an investigator with OIRM provided an update on pluripotent stem cell translational research and queried Health Canada on safety testing requirements between embryonic stem cells and induced pluripotent stem cells. There was also a discussion on whether on types of comparability studies that would be required off a well-qualified Master Cell Bank. Health Canada responded that they consider each indication and make a risk assessment on a case-by-case basis. Health Canada has provided some specific responses directly to Dr. Nostro, and we are requesting that they share this with the broader group.
- Dr. Marcelo Pasquini from Centre for Internatinal Blood and Marrow Transplant Registry (CIBMTR) provided an update on new forms and collection methods which are now being applied to collect data from immunotherapy recipients. He provided feedback from US and European regulators on the registry and forms which enables long term tracking, needed for gene modified cell therapies. Health Canada responded that they were interested in this registry but not ready to adopt or apply this format for Canadian centres.
The meeting concluded with a round-table discussion and discussions for fall/winger 2018 meeting. The next meeting is not yet scheduled but will likely take place November/December 2018.