Osteoarthritis is a chronic joint disease that causes pain and disability, and that affects around two million Australians and 30 million people in the USA. With no cure and an aging population, it is estimated that the incidence of osteoarthritis will increase by more than 50% in the next 15 years. Market research estimates that the resulting global osteoarthritis treatment market is expected to grow from a value of US$8.0 billion in 2018 to US$11.6 billion by 2025 (Persistence Market Research 2018 research report: "Osteoarthritis Treatment Market: Global Industry Analysis (2012-2016) and Forecast (2017-2025)."). Preclinical research has shown that MSCs can exert a number of important effects that may improve outcomes in patients with osteoarthritis, including release of cytokines and growth factors that reduce inflammation and promote tissue repair, new blood vessel formation, and regeneration of compromised cartilage.
Cynata’s CYP-004 MSC product will be the subject of a Phase 3 clinical trial being sponsored by the University of Sydney and funded by an Australian Government National Health and Medical Research Council (NHMRC) competitive Project Grant in addition to in-kind contributions from participating institutions. Cynata will supply Cymerus MSCs for use in the trial and will not be required to contribute any cash to fund the project. The clinical trial is entitled Stem Cells as a symptom- and strUcture-modifying Treatment for medial tibiofemoral OsteoaRthritis: a randomised placebo-controlled trial.
The trial will be a randomised, double-blind placebo-controlled trial, which will seek to enrol 440 patients with osteoarthritis of the knee. Participants will receive intra-articular injections of Cymerus MSCs or placebo on three occasions over a period of 1 year, and will be followed up for a total of two years from enrolment. The co-primary endpoints are: (i) the proportion of participants achieving patient-acceptable symptom state (PASS) for knee pain at 24 months; and (ii) central medial femorotibial (cMFT) cartilage loss from baseline to 24 months. Secondary outcome measures will include assessments of pain, other symptoms, physical function and quality of life. The trial will take place at study centres in Sydney and Tasmania, and be led by Professor David Hunter. Professor Hunter is the Florance and Cope Chair of Rheumatology and Professor of Medicine at the University of Sydney and has been Chief Investigator of numerous clinical trials in osteoarthritis. He has more than 450 publications in high-impact journals, including the New England Journal of Medicine, Journal of the American Medical Association and British Medical Journal.
The research team also includes Professor Changhai Ding (University of Tasmania), Professor Stefan Lohmander (Lund University, Sweden), Dr Rachel O'Connell (University of Sydney) and Dr Xia Wang (University of Sydney), as well as numerous associate investigators.