Cynata Therapeutics (CPY) has begun its phase three osteoarthritis clinical trial using its Cymerus mesenchymal stem cell (MSC) product, CYP-004.
The trial is sponsored by the University of Sydney and is funded by an Australian Government National Health and Medical Research Council (NHMRC) grant.
It will take place at study centres in Sydney and Tasmania and will begin with an initial four patients who will be assessed over a four week period.
Once completed, the study will open for a wider enrolment.
The aim of the trial is to assess the effect of Cymerus MSCs on the knee joint structure over a two-year period in 440 patients with osteoarthritis in the area.
The trial will be led by the Florance and Cope Chair of Rheumatology and Professor of Medicine at the University of Sydney, Professor David Hunter.
It also includes Professor Changhai Ding from the University of Tasmania, Professor Stefan Lohmander from the Lund University in Sweden, and Dr Rachel O'Connor and Dr Xia Wang from the University of Sydney.
"There is now cure for osteoarthritis and current treatment options largely focus on alleviating pain rather than modifying the course of the underlying disease," Professor David stated.
"We are delighted to commence this trial, which is designed to evaluate the disease modifying potential of Cymerus MSCs. Consequently, we anticipate that it will be an enormously influential trial, with the potential to inform clinical practice guidelines globally," he added.
MSCs are adult stem cells found in a wide range of human tissue such as bone marrow, placenta and fat tissue.
They are multi-potent, which means they can produce more than one type of cell. For example, they can differentiate into cartilage cells, fat cells, and bone cells.
They have been shown to ease regeneration and effects on the immune system without relying on engraftment (when transplanted cells start to grow and make healthy cells).
Patients will receive either an intra-articular injection of Cymerus MSCs or a placebo three times during a one year period. This will then followed-up for a two year period post enrolment.
Cynata will measure the quality of life, assessment of pain, physical function, and the proportion of participants achieving patient-acceptable symptom state - which is the highest level in which patients consider themselves satisfied with treatment.
"This clinical trial aims to determine whether Cynata's proprietary Cymerus MSC technology is active in the setting of knee osteoarthritis," Chief Operating Officer Dr Killian Kelly said.
"We look forward to advancing this clinical trial to investigate the potential benefits our MSCs could have to treat osteoarthritis patients with this common and debilitating disease," he added.
Cynata has ended the day 6.55 per cent in the green, with shares trading for 89.5 cents each in a $98.38 million market cap.
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Cynata Therapeutics (ASX:CYP) begins phase three osteoarthritis trial - The Market Herald
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