Realizing a Phase I human clinical trial is starting to evaluate the effectiveness and safety of using olfactory nerve cell bridges for the treatment of chronic spinal cord injuries.
Following the death of Professor Emeritus Alan Mackay-Sim AM in 2023, his pioneering research is now set to come to fruition with a Phase I human clinical trial that will investigate the effectiveness and safety of olfactory nerve cell bridge transplants aimed at addressing chronic spinal cord injuries.
According to Professor James St John from Griffith University, olfactory ensheathing cells, found in the olfactory (smell) nerve in the nose, possess unique therapeutic benefits that can aid in nerve repair and regeneration.
“With over 20,000 Australians currently affected by spinal cord injuries and another 300 or more sustaining new injuries each year, it is crucial to bring this therapy into clinical practice at this time,” stated Professor St John.
“We have carefully crafted the trial in collaboration with the spinal injury community, medical professionals, and industry partners to ensure it aligns with the expectations and needs of participants, maximizing the likelihood of success.”
The study will be a randomized, blinded control trial that assesses the effectiveness of olfactory nerve bridge transplantation alongside intensive long-term rehabilitation.
For the procedure, cells will be collected from the patient’s own nose, processed for purity, and molded into specialized nerve bridges before being implanted at the spinal cord injury site.
Participants will also receive intensive rehabilitation for up to a year to promote and enhance regeneration.
“These cells were previously studied in a clinical trial for spinal cord injuries back in 2002 in Queensland by the late Professor Emeritus Mackay-Sim, who was honored as the Australian of the Year in 2017,” remarked Professor St John.
“Since that time, additional trials worldwide have examined these cells, though some promising outcomes were met with hurdles in the preparation and transplantation processes.”
Perry Cross, Executive President of the Perry Cross Spinal Research Foundation (PCSRF), shared, “Three decades ago, I sustained a spinal cord injury that left me paralyzed from the neck down, unable to move, feel, or even breathe independently.”
“It is extraordinary that we are on the verge of developing a treatment that may enable us to mend spinal cord damage and regain some function,” Mr. Cross expressed.
“For any trial participant, being able to stand up and embrace a loved one again or regain any sense of feeling would be transformative.”
“I am enthusiastic to see the trial begin, as this exceptional research holds great promise for individuals affected by spinal cord injuries.”
“I am thankful to all the generous donors who have supported this work over the years.”
The Spinal Injury Project team at the Clem Jones Centre for Neurobiology and Stem Cell Research implemented a translational research approach to innovate a new therapeutic strategy that addresses previous challenges.
Notable improvements involve an advanced cell purification method, a cutting-edge nerve bridge design, and a comprehensive long-term rehabilitation program.
Professor St John, Director of Griffith’s Clem Jones Centre for Neurobiology and Stem Cell Research, emphasized that the high-purity cells and the groundbreaking nerve bridges are crucial to the therapy.
“Despite decades of global effort to find solutions for spinal cord injuries, there remains no clinically available treatment,” he noted.
“We believe that our innovative nerve bridges, coupled with the highly purified olfactory cells, provide the best possibility for treating spinal cord injuries.”
“Preclinical studies have already shown that olfactory nerve bridges can successfully repair spinal cord injuries in animal models.”
“We also previously validated the intensive rehabilitation in two separate clinical trials, funded by the Perry Cross Spinal Research Foundation, which indicated participants with spinal cord injuries appreciated the program.”
The trial seeks volunteers who are living with chronic acquired spinal cord injuries that have persisted for at least four months, but it will initially enroll participants whose injuries are at least 12 months old.
Participants will be sourced from South East Queensland, northern New South Wales, Sydney, or Melbourne, and they will engage in the rehabilitation program at facilities within these regions.
Peter Johnstone, CEO of the Clem Jones Foundation, remarked that the latest project phase underscores the value of philanthropic support for sustained research efforts.
“The Clem Jones Foundation is proud to partner with others in the philanthropic sector to fund this premier research,” Mr. Johnstone stated.
“It demonstrates the significant progress that can emerge from long-term financial commitments to specialized research with the potential to change lives globally.”
Mark Townend, CEO of Spinal Life Australia, expressed enthusiasm about the trial’s launch and the potentially transformative impacts this research could have for those with acquired spinal cord injuries.
“We have been closely monitoring the advancements in this research for years, and it is thrilling to witness the culmination of this hard work in the clinical trial phase,” Mr. Townend said.
“Many of our members are likely to be interested in participating, and we eagerly await the results and what this may mean for the future of spinal cord injury treatment and rehabilitation.”
Professor St John remarked, “Advancing a cell transplantation therapy to a clinical trial within only eight years highlights the effectiveness of our strategic translational research approach.”
“Developing this therapy in Queensland owes much to the incredible support from our funding partners, especially the Motor Accident Insurance Commission (MAIC) as the main funder, along with contributions from the Perry Cross Spinal Research Foundation, the Clem Jones Foundation, NHMRC, MRFF, and the supportive spinal injury community that has inspired and propelled this therapy’s development,” Professor St John concluded.
