Dr Ross Macdonald announces his retirement, with Cynata appointing Chief Commercial Officer Dr Killian Kelly to the role of CEO and Managing Director, effective 1 July 2023. In addition, Dr David Atkins will join Cynata’s board, with Dr Stewart Washer stepping down from his position as a non-executive director.

Learn more on The Market Herald here.

Stuart explores the company's powerful stem cells platform, the great data in Graft-versus-Host Disease and the emerging opportunity in diabetic foot ulcers. We also spoke about why 2022 was such a bad year for Life Science sector investors, but why 2023 can be better.

By Professor David Hunter, Florance and Cope Chair of Rheumatology and Professor of Medicine, University of Sydney and Royal North Shore Hospital

Australians living with arthritis pain are parting with thousands of dollars, sometimes tens of thousands, for unproven stem cell treatments that are no better off than injecting saline. 

It’s been documented that up to 60 practitioners have promoted unproven stem cell therapies in Australia[1], with many of the treatments on offer considered experimental.

Recently I have been seeing a growing number of patients come to me to enrol in the SCUlpTOR trial that I am leading, disappointed they’ve wasted their money on treatments elsewhere – locally and abroad. 

These providers are essentially snake oil salesman. They’re preying on people whose problems haven’t been solved by current medicines, offering hope but delivering no benefit. It’s very worrying. 

Do stem cells work?

Until recently, what they’re doing has been considered medical practice rather than using a therapeutic good, and because they’re using autologous stem cells, which are cells that are taken from the patient and then injected back in, it was not regulated by the Therapeutic Goods Administration (TGA). 

Practitioners providing stem cell or platelet-rich plasma (PRP) therapy for treating osteoarthritis might be able to demonstrate small scale before-and-after anecdotal evidence of efficacy, but there are no good-quality, placebo-controlled trials published in the medical literature supporting their practice and no conclusive evidence from clinical trials that any of these procedures work. As such, no therapeutic guidelines support this practice.

In fact, a trial that I recently conducted into PRP found there was no greater improvement in pain compared to those receiving placebo injections.

Despite this, clinics have popped up across the country offering treatments for a multitude of conditions, including osteoarthritis and various other joint problems, migraines, autism, and MS. While recent reforms introduced by TGA have been designed to ban advertising of unproven stem cell treatments, many clinics are still operating.

There’s clearly an inherent conflict of interest for these practitioners as the treatments are very lucrative. Platelet-rich plasma injections cost upwards of $300 per injection, and you often need 3-4 per area) or upward of $5,000 per stem cell injection. It’s good business for them; they’re exploiting vulnerable people at great cost and potentially at great risk.

Clinical validation is required

To properly explore whether stem cells work in osteoarthritis, I am leading the SCUlpTOR trial – a 440-person trialinvestigation into the potential modification of osteoarthritis using Cynata’s mesenchymal stem cells (MSCs) in people over 40 with osteoarthritis (OA) in their knees, and who have lived with moderate plus pain for several years.

It’s a gold-standard study: a randomised, double-blind, placebo controlled clinical trial designed to discover whether or not stem cell injections into the knee improve symptoms and slow disease progression to improve underlying disease and, therefore quality of life. 

Put simply, if it works, it could be a “cure” for osteoarthritis. And if it doesn’t, we’ll know that. 

The trial is currently open for recruitment in Sydney and Hobart and unlike what’s for sale on the market, there is no cost to patients as there shouldn’t be for participation in a clinical trial. 

Until these results are available and can prove that stem cell treatment is safe and effective for osteoarthritis, people should save their money and consider other proven treatments like weight loss and exercise. 

[1] Munsie et al 2017 Regen Med doi 10.2217/rme-2017-0070 

Professor David Hunter, Florance and Cope Chair of Rheumatology and Professor of Medicine, University of Sydney and Royal North Shore Hospital sat down with Dr Norman Swan to discuss the need for the SCUlpTOR trial to prove whether or not stem cell injections into the knee improve osteoarthritis symptoms and slow disease progression. And how some Australians are spending thousands of dollars on unproven therapies. 

Listen to the interview here: https://www.abc.net.au/radionational/programs/healthreport/arthritis-stem-cells-alzheimers-women-spider-venom-diabetes/101921202

Following her interview earlier in the year, Dr Jolanta Airey, Cynata CMO spoke to Stockhead about the chances of phase 3 clinical trial success, and Cynata’s own osteoarthritis trial. 

Read the story here: https://stockhead.com.au/health/the-chances-of-phase-3-success-and-the-asx-health-stocks-that-are-close-a-home-run/