Regenerative medicine company, Cynata Therapeutics (ASX:CYP), will be kicking off a clinical trial with the University of Sydney this year using its manufactured stem cells to treat osteoarthritis.
The trial will be a phase 2 clinical trial and will be one of the largest clinical trials ever using mesenchymal stem cells (MSCs), recruiting a total 448 patients in Sydney and Tasmania.
MSCs are multipotent stem cells that can self-renew by dividing, and can differentiate into multiple tissues including bone, cartilage, muscle and fat cells, and connective tissue.
In the case of patients with osteoarthritis, MSCs can have a number of effects including the release of cytokines and growth factors that reduce inflammation and promote tissue repair, new blood vessel formation, and regeneration of compromised cartilage.
The MSCs will be manufactured by Cynata’s unique proprietary platform, Cymerus. The platform has a unique method that enables the mass production of stem cells without loss of potency. It requires only one donation, from one donor, one time, to create an infinite amount of MSCs.
“The unique ability of our platform to produce an infinite amount of mesenchymal stem cells without losing potency makes our stem cells particularly well-suited to large-scale clinical trials,” said Dr Ross Macdonald, CEO of Cynata.
The platform also overcomes the existing inherent challenges in the manufacture of MSCs: scalability.
Osteoarthritis represents a market opportunity forecast to be worth US$11.6 billion globally by 2025. It impacts one in 11 Australians, and can be a painful and debilitating condition.
A stem cell therapy could provide osteoarthritis patients with an alternative to a surgical procedure that is often costly, painful and comes with lengthy recovery times.
Importantly for Cynata, it will make no cash contribution to the trial that will be funded by a grant of $1.98 million from the Australian National Health and Medical Research Council (NHMRC). Cynata will also retain full commercial rights to the use of its Cymerus MSCs in osteoarthritis.
The trial will be led by Professor David Hunter, Florance and Cope Chair of Rheumatology, Chair of the Institute of Bone and Joint Research and Professor of Medicine at the University of Sydney.
Professor Hunter said: “We are delighted that the NHMRC reviewers recognised the value of this trial, given that a very small proportion of clinical trial project grant applications are successful.”
The trial is anticipated to commence in the second half of 2019, and if successful in improving the symptoms and knee joint-structure in osteoarthritis patients, it could have a major impact on osteoarthritis treatments globally and improve the lives of millions of patients suffering from knee-joint pain.
The trial will be Cynata’s third phase 2 clinical trial to take place this year. It is slated to commence a phase 2 clinical trial using its MSCs in the treatment of graft-versus-host-disease (GvHD) and critical limb ischemia (CLI).
Results from its phase 1 clinical trial in GvHD were exceptional, with the trial meeting all safety and efficacy end points. Among the participants, 87 percent reported an improvement in severity by at least one grade compared to baseline, and 53 percent were reported to have had their symptoms completely resolved.
This content is produced by Star Investing in commercial partnership with Cynata Therapeutics. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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