A Phase 1 human clinical trial to treat chronic spinal cord injury, the first of its kind in the world, has commenced to test the efficacy and safety of a revolutionary new treatment using nasal cells.
The Griffith University trial has been three decades in the making and involves taking olfactory ensheathing cells, which are specialised cells involved in our sense of smell, from the nose as they have numerous therapeutic properties for repairing and regenerating nerves.
Lead researcher Professor James St John, Head of Griffith’s Clem Jones Centre for Neurobiology and Stem Cell Research and Principal Researcher at the Institute for Biomedicine and Glycomics, is carrying on the legacy of the late Professor Emeritus Alan Mackay-Sim AM.
“Once the cells have been removed from the patient’s nose, they are then used to create an innovative nerve bridge which is about the size of a very small worm,” Professor St John said.
“The nerve bridge is then implanted into the spine at the site of the injury, offering what we think is the best hope for treating spinal cord injury.
“To help stimulate regeneration, patients will undergo intensive rehabilitation for three months prior to the transplantation and then for eight months after the transplantation.
“While primary assessments are to ensure the therapy is safe, we will also be measuring numerous aspects to assess if there are changes in functional outcomes that are important to people living with spinal cord injury.
“The ability to regain some sense of function, whether it’s regaining independent function of their bladder or bowel, regaining movement in their fingers, or the ability to stand and hug a loved one again can improve quality of life.
“Regaining some form of independence can open the world up to people living with a chronic acquired spinal injury.”
The trial, to be conducted at Gold Coast University Hospital, is a blinded and randomised control study with preclinical research demonstrating the olfactory nerve bridges are effective in repairing spinal cord injury in animal models.
CEO of the Clem Jones Foundation, Peter Johnstone, said the latest milestone illustrated how long-term philanthropic support could foster ground-breaking research with the potential to change lives for the better.
“The Clem Jones Foundation has supported this world-leading project from day one alongside other philanthropic groups and individuals which meant it also attracted state and federal government funding commitments,” Mr Johnstone said.
“All of the funding partners recognise that results from medical research never happen overnight but rely on long-term funding as well as the long-term application of the knowledge, skills, and hard work of the talented team of researchers at Griffith University.”
Founder of the Perry Cross Spinal Research Foundation, Perry Cross AM, who became a ventilated quadriplegic at age 19 from a rugby accident, has dedicated his life to advocating for a cure.
“This clinical trial represents a long-awaited breakthrough that speaks to the enduring strength of those impacted by spinal cord injury and the extraordinary belief of those who support us,” Mr Cross said.
“For too long, individuals living with paralysis have been told that recovery lies beyond the horizon of possibility.
“Today, we challenge that notion with evidence, ambition and above all, hope.
“It is proof that philanthropy, when guided by purpose and vision, can accelerate real change. Every contribution has mattered, and each gesture of support has brought us closer to this point.
“For someone like me, who knows all too well the permanence of spinal cord injury, this trial offers not just the possibility of improved function, but a renewed sense of independence and dignity; qualities that define the human experience.”
Professor St John said: “To have a cell transplantation therapy progressing to clinical trial after only eight years is testament to the benefits of the strategic translational research program the team has used.
“To be able to develop the therapy in Queensland is thanks to the incredible support from our funding partners, in particular the Motor Accident Insurance Commission as the major funder, the Clem Jones Foundation, the Perry Cross Spinal Research Foundation, National Health and Medical Research Council, Medical Research Future Fund, and the dedicated spinal injury community which has been the inspiration and driving force behind the therapy development.”
The trial is funded by the Medical Research Future Fund, Perry Cross Spinal Research Foundation, The Clem Jones Foundation, Queensland Government, Nicola and Andrew Forrest, Brazil Family Foundation, Terry and Rhonda White, and Griffith University.
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