A BRISBANE surgical and medical team has begun the world's first clinical trial on spinal cord regeneration by transplanting nasal cells into the spinal cord of a volunteer paraplegic patient.
The historic eight-hour operation was conducted last month by a Princess Alexandra Hospital surgical team consisting of the head of neurosurgery, Dr Adrian Nowitzke, and by visiting surgeons, spinal specialist Dr Paul Licina and ear, nose and throat specialist Dr Chris Perry. Dr Perry earlier had harvested a sliver of cells which then were grown so that surgeons, using a specially designed device, were able to inject 14 million cells into several injured regions of the patient's spinal cord.
The process, which is certain to give hope to millions of paraplegics worldwide, follows successful laboratory experiments at Brisbane's Griffith University and in Spain in which rats whose spinal cords had been severed were able to move their legs weeks after transplanted nasal cells triggered regeneration of the damaged area.
However, key figures in the Queensland Spinal Cord Regeneration Project have cautioned against expectations the treatment now being trialled would enable paraplegics to abandon their wheelchairs and walk again.
They said it would be months before any changes in the volunteers became evident - if at all - and each patient in the trial would undergo a battery of tests to see if there was an improvement in their condition.
Team member Tim Geraghty, the director of the spinal injuries unit of the PA Hospital, emphasised the trial was all about the safety of the procedure.
"We're not expecting too much at all," Dr Geraghty said. "This is to try to prove that we are not going to do any harm, which is the whole purpose of a phase one trial.
"If we get some positive outcomes even better - like feeling coming back in the legs or an improvement in bodily control functions."
Professor Alan Mackay-Sim who, with French neurogenesist Dr Francois Feron, grew the cells in a culture at Griffith University's Centre of Molecular Neurobiology, stressed the project team's view of a positive outcome would be much more conservative than public expectations.
Queensland Premier Peter Beattie congratulated the scientists and doctors involved.
"My message for the past four years has been that biotechnology will bring great benefits to our quality of life as well as finding cures for illnesses such as muscular dystrophy and cancer," Mr Beattie said.
"This announcement is a perfect example of what we are seeking to achieve. Today's announcement of a world-first clinical trial means that the eyes of the world will be on the progress of these trials in Queensland, but there is obviously a long way to go as we watch how the patients fare over the next three years."
A press conference at which full details of the breakthrough procedure will be explained is understood to be scheduled for tomorrow.
The identities, even the sexes, of the patient who underwent surgery and of the three other volunteers who will be operated on later in the clinical trial have been kept secret.
This is to ensure the scientific validity of the trial, with assessors/clinicians deliberately being kept in the dark about which of eight volunteers - five of whom are still to be selected - has undergone the surgical procedure.
A team member said the volunteers, who were approached earlier this year, were given all information possible about what the trial involved to ensure they make certain they knew all the risks involved.
They were subjected to a series of psychiatric tests and to psycho-social counselling to make certain they could cope with the stresses of the trial.
The ethics committees of the two collaborating organisations in the trial, the PA Hospital and Griffith University, examined the proposal when it was brought to them by the project team in August 2000. Only when they were satisfied the trial would not inflict further harm on the paraplegic volunteers did they give their approval.
The PA Hospital Foundation then sanctioned a grant to fund the trial.
Because the spinal cords of patients who suffer a major cord injury can have functional recovery in the six-month period after their accidents, only people who had been paralysed from the waist down for at least six months were selected for the clinical trial.
This was to ensure the project team did not give itself a headstart by working with volunteers who were not severely disabled.
Despite the tight selection criteria, team members are bracing themselves today for a flood of requests from paraplegics and their relatives seeking admission to the trial.
The trial, a collaboration between Princess Alexandra Hospital clinicians and Griffith University scientists, has been supported by the $200,000 PA Hospital Foundation grant.