Spinal Injury Project
Nerve Bridge Transplantation and Rehabilitation Human Clinical Trial
In partnership with
The Spinal Injury Project at Griffith University, in partnership with the Perry Cross Spinal Research Foundation, is on the cusp of starting a world-first Nerve Bridge Transplantation and Rehabilitation Human Clinical Trial. The Spinal Injury Project is part of the Clem Jones Centre for Neurobiology and Stem Cell Research and is directed by Professor James St John.
The Spinal Injury Project has a team of internationally recognised researchers based in state-of-the-art laboratories at the Gold Coast and Nathan campuses of Griffith University. The project team is a leading group of research specialists including bioengineers, medical doctors, biological scientists and educators working together to develop this breakthrough treatment. The research was first initiated by the late Griffith University Professor Emeritus, and 2017 Australian of the Year, Alan Mackay-Sim almost 20 years ago. He was a pioneer in stem cell research and was successful in taking cells from the olfactory (nasal) system, transplanting them to the injury site and demonstrating that it was safe for use in humans.
Building on Professor Mackay-Sim’s incredible legacy, the ongoing research at Griffith University has made considerable improvements by developing a nerve bridge which improves how the cells are transplanted. The team has shown that the nerve bridges can repair spinal cord injury in preclinical work, and the clinical trial hopes to show that the nerve bridges can repair spinal cord injuries in humans.
The Spinal Injury Project is translating a comprehensive cell transplantation therapy with an exercise-based rehabilitation therapy to treat traumatic spinal cord injury. This world-first treatment for spinal cord injury uses specialised cells from within the nose. The cells are called olfactory ensheathing cells (OECs) and they can work in numerous different ways to stimulate repair of nerves. The olfactory cells are purified from a simple biopsy taken from within the nose, a cellular nerve bridge of OECs is manufactured for transplantation into the injured spinal cord, where the special regenerative capacity of transplanted OECs stimulates spinal cord regeneration.
The therapy has been developed over the last 10 years by a large team at the Clem Jones Centre for Neurobiology and Stem Cell Research, Griffith University in Queensland. The diverse team has over 40 translational biomedical researchers who come from 19 different countries. In addition to the lab members, the team also works with many external specialist researchers, clinicians and allied health professionals to drive the therapy to clinical trial.
The Foundation is proud to partner with Griffith University on this exciting endeavour with the support of our wonderful donors and supporters.
Learn more about the clinical trial and development of nerve bridges:
The Treatment
This ground-breaking, world-first treatment involves the transplantation of the patient’s own olfactory cells from the nose into the spinal cord. The cells are formulated into nerve bridges which are transplanted directly into the injury site. To help stimulate regeneration and to reinforce connections that are made, intensive rehabilitation takes place before and after the cell transplantation.
The human clinical trial is anticipated to start in 2025 and aims to test the safety and efficacy of the nerve bridge transplantation and rehabilitation. The trial will have thirty participants, twenty who will undergo the nerve bridge transplantation and rehabilitation program (outlined below) and ten participants who do only the rehabilitation program.
The Cost
The Nerve Bridge Transplantation and Rehabilitation Human Clinical Trial is a truly inspirational endeavour. Through generous supporters like you, our funding partners, philanthropists, and our incredible fundraising community, the Foundation has helped raise the $8.5M needed to commence the trial for 15 people. This includes a $2M contribution from Queensland Health and $1M from Nicola and Andrew Forrest.
Professor James St John and his team were also awarded a Medical Research Future Fund Stem Cell Therapies Grant of $6.8M for the clinical trial. With this funding award, the clinical trial will now be open for thirty participants living with a spinal cord injury.
What is the current status of the Spinal Injury Project Human Clinical Trial?
The good news is that we are on track to commence the trial in 2025, subject to the relevant approvals being in place.
The past year has been dedicated to intensive preparation for the Phase I cell therapy and rehabilitation clinical trial, scheduled to commence recruitment in 2025. A key milestone was the appointment of a Contract Research Organisation (CRO).
With this crucial partnership established, Griffith University is now actively working with the CRO to advance the development of the clinical trial set up. Simultaneously, they are engaging with external stakeholders and vendors such as the rehabilitation providers and companies who will play vital roles in data collection, such as those providing blood tests and radiology services.
Significant progress has also been made on the regulatory front. Ethics applications, protocols and investigator’s brochures have been meticulously prepared and have received approval from the hospital’s HREC committee. The trial has also been registered on the Australian New Zealand Clinical Trials Registry. Finally, we are currently awaiting the final green light from the hospital’s research governance organisation. Once this approval is granted, official recruitment for the trial will begin.
To de-risk the trial, the Foundation with the support of our incredible donors, has already funded two rehabilitation clinical trials run by Griffith University and purchased an advanced LiveCyte microscope for the safety testing of the cells in preparation for the trial.
- The first rehabilitation trial involved people who had previous experience with rehabilitation programs but not at the intensity that is needed for the trial. The outcomes showed that the intensive long-term rehabilitation program is safe and that participants enjoyed the program and peer support. The Foundation fully funded this rehabilitation trial at a cost of $450,000 for five participants – read more here.
- The second rehabilitation trial showed that people with little experience with intensive rehabilitation were also able to safely complete the program and they too enjoyed the peer support and experience. Together these trials provided confidence that intensive long-term rehabilitation is suitable for people living with chronic spinal cord injury. The Foundation fully funded this second rehabilitation trial at a cost of $420,000 for five participants – read more here.
- Safety is a priority for the trial and for this reason the Foundation funded the LiveCyte microscope for the research team. This microscope uses live-cell imaging to track the fate of all cells that are being viewed. This allows the researchers to confirm that the cells are behaving in the appropriate way and that there are no undesirable cells within the population. This new technology provides an incredible advance for cell transplantation therapies and to have it as part of the trial is of immense importance for safety screening. The livecyte microscope was funded in full by the Foundation through the support of our donors at a cost of $400,000 – read more here.
Learn more on a virtual or in-person Tour!
We hold regular tours of our research lab on the Gold Coast, available to the public on a monthly basis. Learn more about attending an in-person tour or watch our most recent virtual tour via the button below!
Are you interested in participating in the upcoming clinical trial?
The human clinical trial for olfactory nerve bridge cell transplantation combined with intensive exercise therapy will be commencing soon on the Gold Coast, Queensland.
To learn more on the status of the trial, the current criteria to participate and to register your interest please visit the Griffith University website. The webpage will be updated with an Expression of Interest link once recruitment begins. You can also email scitrial@griffith.edu.au with any questions.
Once news becomes available about the trial, we will email the database to advise of the next steps. The recruitment will all be done independently from the Foundation and conducted by Griffith University who will host the Expression of Interest Application.
