Cynata to launch phase 2 clinical trial with the University of Sydney to treat osteoarthritis with its stem cells. 

Special Report: Regenerative medicine company, Cynata Therapeutics (ASX:CYP), has partnered with the University of Sydney to launch a phase 2 clinical trial using its manufactured stem cells to treat osteoarthritis.

Osteoarthritis is a degenerative joint disease most often found in the knee, hips, and finger joints. There are more than 50,000 hospitalisations every year in Australia for knee surgery related to managing osteoarthritis.

Cynata Therapeutics (ASX:CYP) will be kicking off a clinical trial with the University of Sydney using its manufactured stem cells to treat patients with osteoarthritis in their knee joint.

A successful stem cell therapy could provide patients suffering from osteoarthritis with a readily available and non-surgical solution.

One of the largest stem cell trials

The trial will also be one of the largest trials ever run using mesenchymal stem cells (MSCs). The 448 patients are expected to be enrolled throughout Sydney and Tasmania.

The MSCs are manufactured using Cynata’s proprietary Cymerus platform that uses a unique method to produce the cells at scale.

A key challenge to date for many trials has been the need for multiple donors and a loss of potency. The Cymerus platform ensures there is no loss of potency and does not require multiple donors in order to make an infinite amount of MSCs.

“The unique ability of our platform requires only one blood donation, one time, to create the starting material that produces an infinite amount of our mesenchymal stem cells. This makes our stem cells particularly well-suited to large-scale clinical trials,” said Dr Ross Macdonald, CEO of Cynata.

Importantly, the trial will be funded by the Australian National Health and Medical Research Council (NHMRC). It’s approved a grant to fund the second phase of the clinical trial.

Potential to eliminate the burden for patients and healthcare system

Osteoarthritis affects 1 in 11 people in Australia – making it a huge burden for millions and costly for the healthcare system.

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. If Cymerus MSCs are found to improve symptoms and knee joint-structure in this trial, it would have a substantial and immediate impact on osteoarthritis management worldwide, with major implications for reducing the osteoarthritis disease burden.”

The trial is expected to commence in the second half of 2019 and represents a significant achievement for Cynata. It will be the company’s largest clinical trial to date and is likely to be its third phase 2 clinical trial to take place in 2019.

It is also targeting phase 2 clinical trials using its MSCs in the treatment of graft-versus-host-disease (GvHD) and critical limb ischemia (CLI).



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