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Trials and Translation
Bringing stem cell therapies to Ontario
Stem cells were first identified in Ontario in 1961. Today, Ontario remains a world leader in stem cell and regenerative
medicine research. The Ontario Institute for Regenerative Medicine is helping push even further by supporting the
scientists, clinicians and technologies that will make today’s regenerative medicine advances tomorrow’s reality.
Phase 1
15–30
patients
Animal and/or
laboratory
studies
About 4-1/2 years
Phase II
Fewer than
100 patients
Phase III
100s to
1000s of
patients
About 8-1/2 years
Phase IV
After
approval
Health
Canada
approval
About
1-1/2 years
How science becomes medicine
Before a new discovery becomes a treatment or cure, it goes through a rigourous process to ensure that it’s both
safe and effective. Early tests often involve animals before moving on to humans. Human clinical trials have four
phases and the therapy must pass each phase before getting approval for regular clinical use.
Cell therapy clinical trials in Ontario in 2015
Each year, thousands of Ontario patients take part in a clinical trial to help move science forward. These eight trials
represent some of the current and planned trials involving stem cells and are areas of active interest for OIRM.
For information on these trials and their sponsors, visit clinicaltrials.gov.
BRAIN AND/OR NERVES
HEART
2 Phase II trial using mesenchymal
stem cell for patients with Multiple
Sclerosis: 40 patients; Ottawa*
2 Phase II trial using genetically
modified stem cells for cardiac patients
following a heart attack: 100 patients;
Ottawa and Toronto*
Phase III trial using a diabetes drug to
stimulate brain repair and recovery in
children treated with radiation for
malignant brain tumours: 30 patients;
Toronto*
2015
Phase II trial injecting mesenchymal
stem cells into heart tissue of patients
with advanced heart failure who have
been treated with left ventricular assist
device: 120 patients; Toronto*
8 trials
11 partners
BLOOD
1 Phase I trial for safety of immune cells
to treat refractory blood cancer
relapse after bone marrow transplantation: 15 patients; Toronto*
3 Ontario cities
647+ patients
SPINE
1 Phase I/II trial testing effect of
transplantation of human stem cells
in patients with cervical spinal cord
trauma: undetermined number of
patients; Toronto*
Billions of
stem cells
KNEE
DIGESTIVE SYSTEM
1 Phase I-II trial using stem cells for the
treatment of mid to late stage knee
osteoarthritis; 12 patients, Toronto*
1 Phase III trial using mesenchymal
stem cells to induce remission of
Crohn’s Disease: 330 patients; London
and Toronto
*OIRM researchers leading trial
Your imagination. OIRM’s expertise. Our future.
www.oirm.ca
Funding provided in part by the Government of Ontario.