A spinal exam is underway at a clinic south of Sydney. On the table is Kylie Stewart, who suffers from severe lower back pain.
"I have two bulging discs, in my lower spine," says Stewart, 38.
"It's pretty debilitating. I can't play sport, I have pretty much given up. I used to run a lot. I can't do that anymore, obviously.
"I just feel old and incapable and upset — really, really upset."
Kylie Stewart was once a keen runner. Source: Supplied / Kylie Stewart
Human trials of a promising technique designed to rehabilitate spinal discs are set to begin next year. Stewart is on the waiting list.
"If this works, then it's just insane what it could do for people," she says.
Overseeing the project is orthopaedic spine surgeon Dr Ashish Diwan, director of spine service at the St. George Hospital's Department of Orthopaedic Surgery.
Dr Ashish Diwan looks at images of spinal damage. Source: SBS / Spencer Austad
"This trial is focused on trying to cure an intervertebral disc injury by healing it. So, we inject a recombinant protein which can mobilise the stem cells, which are just sitting in the bone above and below into the disc.
"And when they arrive at the disc, they actually become disc-like cells and they heal the disc."
The trial will begin in January 2025 with an initial group of about 20 participants. Diwan says that will increase it to 80 people and eventually around 250 to 300 people.
It has government support and financial backing from SoHi, a venture capital firm based in NSW's Southern Highlands that specialises in biotech.
Diwan is one of the fund’s founders and is excited by the trial’s potential.
"Firstly, we should see pain relief. We have evidence that [this technique] does cause pain relief, which we should see in weeks.
"Then the second phase we should start seeing evidence of disc repair. That will take about three months to six months.
"If we can save at least 50 per cent of the trial participants from heading towards spinal fusion, that would be a big success."
Diwan says any commercial release may still be five years away. However, these first human trials follow four years of rigorous testing on animals.
"In all circumstances where there was a mechanical compression injury or a direct injury, we showed that it heals. If there was pain that got modified too."
For Stewart, that pain is a constant. The mental health nurse is the mother of a teenage son and cannot contemplate bearing more children.
"Having another child, I would not be able to carry it. Even being pregnant, it would be impossible," she says.
Dr Ashish Diwan in consultation with Kylie Stewart. Source: SBS / Spencer Austad
"It's like a pressure in the lower part of my back, in the lumbar spine. It's a constant pressure and driving I am already pre-empting how I'm going to feel when I stand up. I cringe constantly because I know what's going to happen," she says.
The disc injury occurred while recovering from knee surgery from a sporting accident, and during a light workout at the gym.
"The next day I woke up and I literally could not move. It was excruciating pain and my right hip was higher than my left and I could not straighten my back," she says.
Kylie Stewart has high hopes for the trial next year. Source: SBS / Spencer Austad
"It's sad, I do not feel like I have my life under control at the moment. I feel like there's no hope. I always imagine if I feel like this now, how am I going to feel in 10, 20, 30 years' time?
"How much worse is it going to get if I don't get it fixed?"
A recent study by the University of Sydney, published in the Lancet Rheumatology, predicts that the number of back pain cases in Australia will rise by 50 per cent by 2050.
The increase is partly due to population growth and partly linked to overall ageing.
"We identified for the first time, that the peak prevalence is around 80 to 85 years of age," says lead author, Professor Manuela Ferreira.
Professor Manuela Ferreira from the University of Sydney. Source: Supplied / Bill Green / Manuela Ferreira
"Occupational factors include work that involves vibration or long standing and long sitting, for example driving. Other factors relate to lifting and carrying, as well as smoking and high BMI," she says.
"Low back pain has been considered the main cause of disability in the world since 1990. Our analysis paints a picture of growing low back pain cases globally, putting enormous pressure on our healthcare system.
"We estimate that around 623 million people suffer from low back pain and by 2050 we expect 850 million people with back pain around the world, which is again a very large number," she says.
Dr Nashwa Najib is a spine researcher. Source: SBS / Spencer Austad
"Back pain really affects the entire spectrum of human life, not just physical health. It affects psychological wellbeing, it affects financial health and as well as interpersonal relationships.
"I'm positive that the impact [of this trial] is going to be massive, not just for the patients improving their spinal health overall, but also for the practicing clinicians. It gives them that extra edge."
Diwan has devoted 25 years to spinal surgery. However, he hopes these trials will offer a viable alternative to spinal fusion.
"It will be very disruptive. It'll be very gratifying. It'll change the productivity of nations, it'll improve people's mental health.
"We will all be walking more, running more, taking less pain medication. We will be enjoying family time more."
Spinal patient Stewart says her number one goal is getting back to what she loves.
"I literally just can't wait to run again. I told myself I would never do a half marathon again. But if I could run, I would absolutely do another one just because I can."
