A Phase I clinical trial has begun to assess the use of olfactory ensheathing cell nerve bridges for treating chronic spinal cord injuries. Researchers at Griffith University are testing the safety and efficacy of transplanting these specialized cells, harvested from the patient's own nose, to repair damaged spinal cords. The trial combines the cell transplant with a year-long intensive rehabilitation program.
Professor James St John, Head of Griffith’s Clem Jones Centre for Neurobiology and Stem Cell Research, explained that olfactory ensheathing cells, found within the olfactory nerve, possess therapeutic properties that can regenerate and repair nerves. "With more than 20,000 Australians living with spinal cord injury, and another 300 or more people having spinal cord injury each year, now is the time to translate this therapy into the clinic," said Professor St John.
Innovative Nerve Bridges
The trial addresses limitations encountered in previous spinal cord injury cell transplantation attempts. Earlier trials faced technical difficulties in preparing and transplanting the cells. The current approach uses an innovative cellular nerve bridge, combined with an enhanced cell purification procedure. These nerve bridges, measuring 1-2 cm, are constructed from millions of olfactory ensheathing cells.
"Our innovative nerve bridges, combined with the high purity olfactory cells, offer what we think is the best hope for treating spinal cord injury," Professor St John stated. The nerve bridges allow surgeons to place the cells directly over and through the scar tissue at the injury site, facilitating connections and growth factor secretion.
Trial Design and Rehabilitation
The trial is a blinded and randomised control study. Participants will undergo intensive rehabilitation for up to one year to reinforce nerve regeneration. A third of the participants will receive the intensive rehab program without the nerve bridge transplant to provide a control group.
Olfactory Ensheathing Cells: A Unique Approach
Spinal cord injuries are difficult to treat because the central nervous system's cells do not regenerate in adults. Olfactory nerves are an exception, regenerating every 6-8 weeks due to their role in protecting the respiratory system. This unique regenerative capacity makes their stem cells suitable for repairing damaged spinal cords.
Overcoming Past Challenges
Previous trials, including one in 2002, showed the safety of using stem cells harvested from the patient's own nose to treat spinal injuries. However, challenges remained in cell preparation, purity, and delivery. Earlier methods involved injecting cells in liquid suspension, which lacked cell-to-cell contact. The new nerve bridge approach aims to overcome these issues.
Funding and Future Directions
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. Researchers hope that olfactory ensheathing cells could eventually be used to treat brain injuries or neurodegenerative diseases, although Professor St John notes that brain injuries are "much more difficult."
Call for Participants
The trial seeks volunteers with chronic acquired spinal cord injury who have had their injury for at least four months, although the trial will start with people whose injuries are at least 12 months. Participants will be from South East Queensland, northern New South Wales, Sydney or Melbourne and will undergo the rehab program at a rehabilitation partner in those areas.
