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Canada’s first clinical trial of innovative cell therapy for osteoarthritis

What you need to know

Treatments to limit the impacts that osteoarthritis (OA) has on lives are limited. Cell-based therapies could hold the key, but have not yet been proven to be safe or effective. In 2019, Canada’s first clinical trial on cell therapy for advanced knee OA revealed that it could be a safe approach to reducing joint pain and improving function, likely by combatting inflammation. These groundbreaking discoveries lay the foundation for larger clinical trials on the path to new treatments.

What is this research about?

Osteoarthritis (OA) is the most common type of arthritis, with up to 5 million Canadians living with its debilitating impacts. While some medications and lifestyle modifications can help relieve its symptoms, better treatments are needed. Researchers have started investigating the potential of injecting cells isolated and expanded from a patient’s own bone marrow into their joint, but they didn’t know how the cells worked as a therapy in the body, what dose to use, or which patients have the best chance at responding well.

What did the researchers do?

Dr. Sowmya Viswanathan and her team led Canada’s first clinical trial of the cell therapy in 12 patients with moderate to advanced knee OA. Special cells were taken from a tablespoon of bone marrow from the patient, expanded in cultures, and tested for their quality, safety and potency in the lab (including the activity of key genes). They were then given in a single injection into the same person’s affected knee, guided by ultrasound. The researchers tracked the patients’ symptoms and what was happening in the body over one year.

What did they find? 

This innovative treatment safely reduced pain and stiffness and enhanced quality of life one year after the injection. In the body, the injected cells appeared to be working by reducing inflammation and modulating inflammatory immune cells in the joint. Injecting cells shown to have an anti-inflammatory gene fingerprint in the lab led to better patient responses. 

How can this research be used? 

This pioneering Canadian study established the initial safety profile of this potential new cell treatment for people with knee OA, which is necessary before beginning larger clinical studies of its effectiveness. It was the first trial to delve into how the injected cells actually worked once they were in the joint, and the first to show that the gene fingerprint of the cells could be used to predict whether the treatment would work in a given patient.

These insights can be used in the next phase of clinical trials to boost the effectiveness of “next-generation” cell therapies and pick the right patients who will respond the best, advancing personalized, precision medicine – the right treatment, for the right patient, at the right time.

This study showcases Canadian researchers as leaders in the field of cell therapy for arthritis. While this trial focused on a small group of people with advanced knee OA, it provides a foundation of evidence that researchers may eventually expand upon to test the therapy in earlier-stage knee OA, OA in other joints, or other types of arthritis.

What impact could this have?

The impact of OA on people’s lives can vary widely, and for people with severe OA, it can be devastating. If this cell therapy continues to show promise through the rigorous phases of clinical trials and regulatory approval in Canada, it could be a game changer. Reducing joint inflammation and pain and restoring mobility and quality of life with a single injection of cells could give people with knee OA back the life they’re missing.

About the researchers

Dr. Sowmya Viswanathan, a scientist at the Krembil Research Institute at the University Health Network and an assistant professor at the University of Toronto, was awarded an Arthritis Society Canada Young Investigator Operating Grant in 2015 that helped support this research – the first grant in her career. Dr. Alejandro Gómez-Aristizábal, a co-author on this study, was also supported by an Arthritis Society Canada Postdoctoral Fellowship awarded in 2015. Several other trainees in the Viswanathan lab have also received Arthritis Society Canada training awards, including PhD students Mable Chan and Kevin Robb, and postdoctoral fellow Dr. Razieh Rabani.

Researcher Reflection

Photography of Sowmya Viswanathan

This trial was the first to really show how these cells worked in a patient. It was also important to note that different patient cells worked differently. To see this in our data, even with such a small sample size, was striking. We are now working to improve the activity of the cells to get what we hope are better responses in the context of OA.

–    Dr. Sowmya Viswanathan, University Health Network

Real-world Reaction

Osteoarthritis in my right knee made my mobility painful and really curtailed my activities. I tried using various anti-inflammatory drugs, had arthroscopic surgery, and finally a total knee replacement. The ability to use my own cells to reduce the inflammation could have saved me two surgeries and a lot of pain!

–    Mary Lou Boudreau, Arthritis Society Canada Online Consumer Panel Member

Canada’s first clinical trial of innovative cell therapy for osteoarthritis

Publication citation

Chahal J, Gómez-Aristizábal A, Shestopaloff K, Bhatt S, Chaboureau A, Fazio A, Chisholm J, Weston A, Chiovitti J, Keating A, Kapoor M, Ogilvie-Harris DJ, Syed KA, Gandhi R, Mahomed NN, Marshall KW, Sussman MS, Naraghi AM, Viswanathan S. Bone marrow mesenchymal stromal cells in patients with osteoarthritis results in overall improvement in pain and symptoms and reduces synovial inflammation. Stem Cells Transl Med. 2019;8(8):746-757.