Spinal Injury Project

Nerve Bridge Transplantation and Rehabilitation Human Clinical Trial

In partnership with

Summer Safety 22233

What is the Spinal Injury Project?

What if the ability to repair a spinal cord injury became a reality in the next five years? The Spinal Injury Project at Griffith University, in partnership with the Perry Cross Spinal Research Foundation, is on the cusp of making this happen with 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.

Perrywebsite

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.

Alan Mackay Sim 3

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 2024 and aims to test the safety and efficacy of the nerve bridge transplantation and rehabilitation. The trial will have fifteen participants, ten who will undergo the nerve bridge transplantation and rehabilitation program and five participants who do only the rehabilitation program. 

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The Cost

Participants will train intensively at a rehabilitation provider for 3 months at the start of the trial, and then 8 months at the end.

Throughout the trial functional, medical and psychological assessments will be conducted to determine the outcomes for each participant.

The Spinal Injury Project is reinventing and rethinking how cells can grow leading to the creation of new cell products. By combining advanced cell purification and engineering techniques the team has designed three-dimensional nerve bridges that allow neurosurgeons to precisely place the cells into the injury site. This dramatically improves the survival of the cells.  

By enabling the cells to form stable connections within the nerve bridge prior to transplantation, the cells rapidly form a permissive bridge over the injury site that allows the spinal cord nerve cells to regenerate. Using the patient’s own cells greatly improves the safety of the treatment. This results in a treatment that has extremely rapid production times, is more effective and more affordable.

The cost to run this trial for fifteen participants is $8.5M. 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, we have raised $7.6M of the funding needed to commence the trial.

The Foundation and Griffith University will continue to work together to fundraise to ensure the funding required is raised in full.

What is the current status of the Spinal Injury Project Trial?

The good news is that we are on track to commence the trial in mid-2024, subject to the relevant approvals being in place. The first approval is the human ethics which considers the safety and benefits of the treatment. The second approval is research governance which ensures that the medical safety team is appointed, contracts with all the providers and partners are in place, and that funding and insurance are available. Once the approvals are obtained, then advertising and recruitment will commence.

Trial2

Thanks to the generous donations from the community and partner organisations including; Queensland Health, Nicola and Andrew Forrest, the Clem Jones Foundation, Brazil Family Foundation, Rhonda and Terry White and Griffith University, we have funding to proceed with the original plan to have fifteen people recruited to the trial, ten for the nerve bridge transplantation and rehabilitation program, plus five controls who will do just the rehabilitation program.

The Spinal Injury Project team is also seeking additional funding from various government and international funding agencies to expand the trial to 30 participants, but the outcomes are uncertain and won’t be known for many months. For this reason, the team has decided to commence the trial for the fifteen participants with the funding that has been raised so far.

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 microscope for the safety testing of the cells.

  • 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 below.
  • 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 below
  • 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 below

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 2024 and aims to test the safety and efficacy of the nerve bridge transplantation and rehabilitation. The trial will have fifteen participants, ten who will undergo the nerve bridge transplantation and rehabilitation program and five participants who do only the rehabilitation program. 

Screenshot 2024 02 07 At 9.55.26 am

The Cost

Participants will train intensively at a rehabilitation provider for 3 months at the start of the trial, and then 8 months at the end.

Throughout the trial functional, medical and psychological assessments will be conducted to determine the outcomes for each participant.

The Spinal Injury Project is reinventing and rethinking how cells can grow leading to the creation of new cell products. By combining advanced cell purification and engineering techniques the team has designed three-dimensional nerve bridges that allow neurosurgeons to precisely place the cells into the injury site. This dramatically improves the survival of the cells.  

By enabling the cells to form stable connections within the nerve bridge prior to transplantation, the cells rapidly form a permissive bridge over the injury site that allows the spinal cord nerve cells to regenerate. Using the patient’s own cells greatly improves the safety of the treatment. This results in a treatment that has extremely rapid production times, is more effective and more affordable.

The cost to run this trial for fifteen participants is $8.5M. 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, we have raised $7.6M of the funding needed to commence the trial.

The Foundation and Griffith University will continue to work together to fundraise to ensure the funding required is raised in full.

What is the current status of the Spinal Injurt Project Trial?

The good news is that we are on track to commence the trial in mid-2024, subject to the relevant approvals being in place. The first approval is the human ethics which considers the safety and benefits of the treatment. The second approval is research governance which ensures that the medical safety team is appointed, contracts with all the providers and partners are in place, and that funding and insurance are available. Once the approvals are obtained, then advertising and recruitment will commence.

Trial2

Thanks to the generous donations from the community and partner organisations including; Queensland Health, Nicola and Andrew Forrest, the Clem Jones Foundation, Brazil Family Foundation, Rhonda and Terry White and Griffith University, we have funding to proceed with the original plan to have fifteen people recruited to the trial, ten for the nerve bridge transplantation and rehabilitation program, plus five controls who will do just the rehabilitation program.

The Spinal Injury Project team is also seeking additional funding from various government and international funding agencies to expand the trial to 30 participants, but the outcomes are uncertain and won’t be known for many months. For this reason, the team has decided to commence the trial for the fifteen participants with the funding that has been raised so far.

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 microscope for the safety testing of the cells.

  • 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 – you can read more here. (https://www.pcsrf.org.au/intensive-rehabilitation-trial-1-results/)
  • 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 – you can read more here. https://www.pcsrf.org.au/intensive-prehabilitation-trial-is-underway/
  • 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 – you can read more here. (https://www.pcsrf.org.au/cutting-edge-microscope-to-help-find-a-cure-for-paralysis/)

What is the Spinal Injury Project?

The Spinal Injury Project is in pursuit of a cure and is working with a laser focus towards the ultimate goal – a Human Clinical Trial. 

This ground-breaking, world first project involves the transplantation of the patient’s own olfactory ensheathing cells (OECs) from the nose into the spinal cord. This experimental treatment has shown promise in previous human clinical trials and now needs further refinement. 

The SIP team is reinventing and rethinking how cells can grow leading to the creation of new cell products. By combining advanced cell purification techniques and engineering, the team is designing three-dimensional nerve bridges that will help regenerate the spinal cord. 

These 3D cell constructs use newly invented, award winning technology involving 3D printed templates. This methodology ensures patients receive optimal restoration of motor and sensory function and outcomes are as consistent as possible. 

This approach has recently been successfully tested in pre-clinical models and has shown promising functional outcomes. This incredible approach has the potential to result in the first widely available treatment for spinal cord injury and it is being developed here in Australia.

Learn more about the Rehabilitation Project
Join us for a Virtual Tour of the Lab
Download the Spinal Injury Project project outline
Find out the latest news on the Spinal Injury Project (SIP)

Find out the latest on the Spinal Injury Project (SIP)

Rehab Overview

  • Institution:Griffith University
  • Lead Researcher:Dr James St John
  • PCSRF funding period:2020-2021
  • Total Funds Committed:$450,000
Currently Funded Project, Griffith University, Currently Funded Griffith
The Intensive Rehabilitation Trial funded by PCSRF will begin in early 2021 and is the next step towards finding a cure for paralysis.  Our goal is to conduct a Human Clinical Trial as part of the Spinal Injury Project and restore movement in people suffering with paralysis. However, before we can do this, we need […]
  • Institution:Griffith University
  • Lead Researcher:Assoc Prof. Jenny Ekberg
  • PCSRF funding period:2018 – 2022 (Ongoing)
  • Total Funds Committed:$450,000
Currently Funded Project, Griffith University, Currently Funded Griffith
This project, led by Assoc Prof Jenny Ekberg is about analysing how cells isolated from the nose – known as olfactory ensheathing cells (OECs) – can clean up the ‘debris’ and bacteria that surrounds them. Up until now, the Spinal Injury Project has been focused around using the cells to create a 3D bio-degradable nerve […]

Interested in participating?

Thank you for your interest in supporting the Perry Cross Spinal Research Foundation and the Spinal Injury Project at Griffith University and participating in this ground-breaking trial

It is important to note, we do not have any criteria or details about recruitment for this human clinical trial as yet, but to stay up to date with our research news please complete this secure form so we can add you to our database and send you regular newsletters.

Once news becomes available about the trial, we will email the database to advise them 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.

Want to learn more?

We hold regular tours of our research lab on the Gold Coast and if you would like to learn more about booking a tour or you are unable to join us in person you can view our virtual lab tour.

We hold regular tours of our research lab on the Gold Coast and if you would like to learn more about booking a tour or you are unable to join us in person you can view our virtual lab tour.

We also suggest if you follow our socials to stay up to date and to help us spread awareness, we encourage you to share our posts with your friends and family.

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