Clinical Trials Initiative

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

Current trials:

Investigators Trial Name (click for more information) Condition Phase
Armand Keating - UHN Safety study looking at the use of genetically-modified autologous stem cells for the treatment of males with Fabry disease Fabry Disease I
Lauralyn McIntyre - OHRI Cellular Immunotherapy for Septic Shock: A Phase I Trial (CISS) Septic Shock I
Jas Chahal & Sowmya Viswanathan - UHN Human autologous MSCs for the treatment of mid to late stage knee OA Osteoarthritis I-II
Mark Freedman and Harry Atkins - OHRI Safety and efficacy of intravenous autologous mesenchymal stem cells for MS: a phase 2 proof of concept study (MESCAMS) Multiple Sclerosis II
Terry Yau - UHN Safety and efficacy of intramyocaridal injection of mesenchymal precursor cells on myocardial function in left ventricular assist device receipients Heart failure II
Duncan Stewart - OHRI The enhanced angiogenic cell therapy - acute myocardial infarction trial (ENACT-AMI) Heart failure II
Don Mabbott - SickKids Placebo controlled double blind crossover trial of metformin for brain repair in children with cranial-spinal radiation for medullablastoma Brain tumours III
Gary Levy- UHN Autologous Hematopoietic Stem Cell Transplantation for Allogenic Organ Transpant Tolerance (ASCOTT) Liver transplant II-III

 

Trials launching soon:

Investigators Trial Name  Condition Phase
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.

 

WORKSHOPS

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.

Upcoming Events:

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. 

For more information on this workshop or future workshops, contact Jodi.garner@oirm.ca

Past Events:

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