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. 



Note: If you are a patient or caregiver seeking information about clinical trials, we recommend you review our FAQs and the featured resources and consult with your physician or specialist.

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 Transplant Tolerance (ASCOTT) Liver transplant II-III
Alan Getgood- Western Confirmatory Study of NeoCart in Knee Cartilage Repair Cartilage defects in knee joint 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 the 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.

Upcoming Events:

OIRM, in collaboration with the Clinical Translation Education Group, is pleased to offer a one-day workshop to provide an overview of the entire clinical translation pathway. This workshop will be held in Toronto on October 5, 2017 from 8:30am to 4:00pm. Travel awards are available for investigators and trainees located outside of Toronto to attend this workshop.

B3 is designed to provide an introductory overview on translating a therapeutic discovery to benefit patients. Modules will introduce concepts related to the sequential stages characterizing the development of a cell therapy or other biotherapy to treat diseases. The participants will learn about the critical steps to consider at each stage of the process through lectures by experts in the field, sharing their experience, and a discussion session.

For more information on this workshop, travel award applications and how to register please go our B3 events page. The deadline to apply for travel awards is Aug 2, 2017. 

This event is brought to you by: 


Stay tuned for information on upcoming workshops and events. 

Past Events:

April 11th, 2017: Featuring guest speakers Patrick Beford (CCRM), Emily Titus (CCRM) and David Courtman (OHRI), this workshop looked at teh practical issues of regulation and manufacturing for cell-based clinical trials. 

November 23 2016: This workshop covered 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 modeling
  • Conducting cell therapy clinical trials for myocardial repair
  • Considerations for clinical trial design
  • Working with the MaRS Excite program