OIRM established the Clinical Trials Initiative in 2015, based on the expertise of the OIRM researchers/clinicians who are leading or have led clinical trials in Ontario. The Initiative hosts workshops (see bottom) focused on problem solving in the areas of regulatory approval, cell manufacturing, access to cells, patient recruitment and registries, reimbursement strategies, and commercialization.
TRIALS IN ONTARIO 2016-17
Trials launching soon:
|Duncan Stewart - OHRI||SAPPHIRE Trial for Pulmonary Arterial Hypertension||Pulmonary Arterial Hypertension||II|
|Lauralyn McIntyre - OHRI||Cellular immunotherapy for septic shock (CISS): A Phase II Multicenter Clinical Trial||Septic Shock||II|
|Don Mabbot - SickKids||Metformin for brain repair in children with Cerebral Palsy||Cerebral Palsy||II|
|Terry Yau - UHN||IMPACT-CABG Trial: IMPlantation of Autologous CD133+ sTem Cells in Patients Undergoing Coronary Artery Bypass Grafting||Heart failure||II|
This trial listing is also available in graphic format for download and sharing. Click the icon below.
The Clinical Trials Initiative Workshop series has been developed to focus on the translation of research studies from the lab into the clinic. Workshops are held 2-3 times per year, each focusing on a different aspect of this process. Participation is open to OIRM scientists, clinicians and trainees.
April 11th, 2017: Cells for Clinical Trials; Regulatory and Manufacturing
This Clinical Trials Initiative Workshop will focus on the practical issues of cell based clinical trials. Patrick Bedford, Manager of Clinical Translation and Regulatory Affairs at CCRM will speak to the regulatory environment sounding use of IPSC in clinical trials and potential hurdles as these cells move towards the clinic. Emily Titus, Director of Technology Development with CCRM will address considerations for cell manufacturing and scale-up production of GMP grade IPSC. Lastly, David Courtman, Senior Investigator at OHRI and Director of the Biotherapeutics Core Facility will provide insights from lessons learned during the process of regulatory approval and implementation of a cell-manufacturing platform to support MSC production for use in cell therapies.
Registration is required, please click here to register.
November 23 2016: This workshop will cover various aspects of clinical trial design and implementation of Phase I/II cell therapy clinical trials. We have three excellent speakers: Dean Ferguson and Monica Taljaard; from OHRI and Pamela Degendorfer of Ozmosis Research Inc.
May 10, 2016: OIRM hosted Patrick Bedford, Senior Policy Analyst, Office of Policy and International Collaboration, Biologics and Genetic Therapies Directorate from Health Canada. Parick provided insight on many topics surrounding clinical trials in Canada. Parick spoke on "Navigating federal regulatory pathways for cell therapy products". To access Patrick's presentation please click here.
February 22, 2016: OIRM hosted a Clinical Trials Reimbursement Workshop surrounding the true cost of clinical trials and the resources available to support these trials. Research and industry partners described the framework of reimbursement policies and engaging with public and private investors. We also hosted a short presentation from each of the OIRM funded Disease Teams presenting their work in the clinical trial space.
September 24, 2015: OIRM's hosted its first Clinical Trials Initiative Workshop, this workshop discussed how to translate science in the lab to clinical trials. Topics including:
- What's needed to get a successful trial started
- Cell manufacturing considerations for clinical translation
- Cell therapy reimbursement modelling
- Conducting cell therapy clinical trials for myocardial repair
- Considerations for clinical trial design
- Working with the MaRS Excite program