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Thread: Nasal Olfactory Mucosa Transplant Clinical Trial in Brisbane Australia

  1. #1

    Nasal Olfactory Mucosa Transplant Clinical Trial in Brisbane Australia

    Repairing the damaged spinal cord using Olfactory Cells.
    Neural Injury Research Unit, School of Anatomy, UNSW

    Project Leader: Prof Phil Waite

    Despite over a century of exhaustive research into spinal cord injury, we still have a limited understanding of the injury mechanisms and can offer no cure. Traumatic spinal cord injuries can lead to the devastating effects of paraplegia and quadriplegia and are particularly common in young people, especially from road accidents or sporting injury.

    Is regeneration possible in the adult spinal cord?

    As well as studying the neuropathology seen in human spinal cord injury, we are also using animal models of spinal cord injury to test possible interventions that could improve outcome. Recent studies indicate that damaged spinal cord axons are capable of growth and reconnection (ie useful regeneration) under certain conditions. One intervention which has supported regeneration of adult rat spinal cord is the use of specialised glial cells from the olfactory pathway, olfactory ensheathing cells (OECs). OECs normally support growth of olfactory axons in the nose throughout life. Our studies, and others, are showing that these cells are also useful in injured spinal cord. For example, we have found that serotonergic axons regenerate across the transection site . In addition, rats with OEC transplants show locomotive recovery in their hind limbs.

    Following these successful experiments, we are now investigating whether human peripheral OEC's have a similar regenerative capacity when transplanted into rat spinal cord. An honours student, Bryan Elston, is studying wehether human OEC's survive, migrate and divide in rat spinal cord. Showing that human cells can support regeneration in the same way as is known for rat cells is an important step towards treatment of human cord injuries.

    Another approach to cord injury is to see whether damaged axons can be rerouted through guidance channels. Honours student Neil Buckland is investigating whether OEC's will allow growth of damaged axons through cut dorsal roots.

    Collaborators:

    A/Prof Alan Mackay-Sim, Biomedical and Biomolecular Science, Griffiths University

    Dr Francois Feron, Biomedical and Biomolecular Science, Griffiths University

    Dr. Stephen Ho, Research School of Biological Medicine, ANU

    Melinda Venn, School of Anatomy, UNSW

    Neil Buckland (Honours student), School of Anatomy, UNSW

    Bryan Elston (Honours student), School of Anatomy, UNSW

    Latest reports indicates that human trials may start later this year (2002) Only a minor surgical technique would be required to obtain the cells from a patients nose. (comment G. Wilson)

    [This message was edited by Wise Young on 01-15-03 at 20:31.]

  2. #2
    Senior Member Max's Avatar
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    Where is UnSw?

    Thanx

  3. #3
    Senior Member
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    UNSW

    This is the University of New South Wales.Australia

  4. #4
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    not this year

    I have spoken with Phil Waite. Although they feel the work is promising they are not in a position presently to commence a human clinical trial this year and are making no commitment as to when might occur. That said, I have made sure her group is aware of the work in Portugal. With hope that will stimulate action towards the clinic.

  5. #5
    http://www.spinetrust.com.au/MainAus...Mackay-Sim.htm

    Professor Mackay-Sim and his team at the Princess Alexandra Hospital

    An Australian surgical team has started the world's first clinical trial on spinal cord regeneration, giving hope to millions of paraplegics. The surgeons transplanted nasal cells into the spinal cord of a volunteer paraplegic patient during a historic eight-hour operation in Brisbane last month. They used a specially designed device to inject 14 million cells into several injured regions of the patient's spinal cord. Three more patients are awaiting the trial surgery. The process follows successful laboratory experiments at Brisbane's Griffith University, and in Spain, where rats whose spinal cords had been severed were able to move their legs just weeks after transplanted nasal cells triggered regeneration of the damaged area.

    But key figures in the Queensland Spinal Cord Regeneration Project cautioned against expectations the treatment would enable paraplegics to walk again. They said it would be some months before any changes in the volunteers became evident -- if at all -- and that each patient in the trial would undergo tests to see if there was any improvement in their condition. The remarkable operation was performed at the Princess Alexandra Hospital by a team led by the head of neurosurgery, Dr Adrian Nowitzke, and visiting surgeons, spinal specialist Dr Paul Licina and ear, nose and throat specialist Dr Chris Perry. Team member Dr Tim Geraghty, the director of the spinal injuries unit at the hospital, emphasised that 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 neurobiologist Dr Francois Feron, grew the cells in a culture at Griffith University's Centre of Molecular Neurobiology, stressed the project team's expectations would be much more conservative than the public's. The identity, even the sex, of the patient who underwent surgery and of the three other volunteers who will be operated on later in the trial have been kept secret. This is to ensure the scientific validity of the trial, with clinicians deliberately being kept in the dark about which of eight volunteers -- five of whom are still to be selected -- has undergone the surgery. A team member said the volunteers, who were approached this year, were given all information possible about what the trial involved to ensure they knew all the risks involved. They then 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.

    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 that the project team did not give itself a head start 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 a $200,000 grant from the PA Hospital Foundation.

    The cells injected into the first volunteer came from the olfactory mucosa, the nasal mucous membrane. This is the only area of the nervous system outside the brain that re-grows. In contrast to most nerve cells, these continue to regenerate throughout life. Indeed, Professor Mackay-Sim said his team had been able to regenerate such cells taken from a person who had died a day earlier. Special olfactory mucosa cells known as olfactory ensheating glial cells are able to enter the central nervous system and guide sensory nerves to grow and reconnect to the brain.

  6. #6
    source:

    Transplanted nasal cells used to repair spinal cord

    Some movement and function could be regained

    By Marilyn Bitomsky

    BRISBANE , AUSTRALIA - An Australian man has become the world's first paraplegic to be given a chance at regaining some movement and function in an historic operation involving transplanting cells from his nose into his spine.
    テつ*テつ*テつ*Key members of the research team were Princess Alexandra Hospital spinal injuries unit head Dr. Tim Geraghty, ear nose and throat specialist Dr. Chris Perry, neurosurgeon Dr. Adrian Nowitzke, orthopedic surgeon Dr. Paul Licina, and Griffith University scientists Alan Mackay-Sim and Dr. Franテδァois Feron (PhD).
    テつ*テつ*テつ*"For many years spinal cord injury has been seen as clinically irreversible, but recent animal experiments provide new hope," Dr. Feron said.
    テつ*テつ*テつ*The team began planning the trial two years ago, following the successful demonstration by the Griffith scientists and colleagues from the University of New South Wales that transplantation of olfactory ensheathing cells resulted in regeneration in the severed spinal cords of laboratory rats.
    テつ*テつ*テつ*The olfactory ensheathing cell is a specialized glial cell with properties both of Schwann cells and astrocytes.
    テつ*テつ*テつ*"We have concentrated on proving the regenerative abilities of the olfactory ensheathing cells which are available from the olfactory mucosa via biopsy through the nose, and we have demonstrated that transplantation of these nasally derived olfactory ensheathing cells can assist reconnection of the fully transected spinal cord in the rat," Dr. Feron explained.
    テつ*テつ*テつ*"Transplantation (in the rat) at the time of acute injury resulted in significant recovery of locomotor behaviour as well as evidence for reconnection of some brainstem motor pathways."
    テつ*テつ*テつ*Feron said recent experiments indicate that olfactory ensheathing cells can also assist recovery when transplanted four weeks after spinal cord transection. That was the amount of time required after biopsy to generate pure populations of olfactory ensheathing cells in large enough numbers for transplantation.
    テつ*テつ*テつ*In fact, from the sliver of nasal tissue harvested by Dr. Perry under anesthetic several weeks before the operation, the scientists were able to grow kilograms of the cells.
    テつ*テつ*テつ*This represented the first time glial cells have been harvested from the nose and grown in vitro , and Brisbane is the only place in the world where glial cells have been grown successfully.
    テつ*テつ*テつ*"We do not know if the success in rats will be replicated in humans," commented Dr. Geraghty.
    テつ*テつ*テつ*He said the upper part of the nose is brain tissue. It is the only part of the brain which continues growing after five years of age. The tissue is regenerated continuously, with completely new cells being grown every 90 days.
    テつ*テつ*テつ*The easy accessibility of these cells avoids the need for removing cells from the brain itself.
    テつ*テつ*テつ*Tests were conducted on the patient's olfactory sense before and after the operation to confirm there was no change in his ability to taste and smell food.
    テつ*テつ*テつ*The transplant procedure involved a laminectomy performed by Drs. Nowitzke and Licina. They opened the covering of the spinal cord near the injury.
    テつ*テつ*テつ*On the day of the operation, the Griffith scientists prepared the cells in a laboratory at Princess Alexandra Hospital.
    テつ*テつ*テつ*As the operation progressed, the cells were delivered from this laboratory in tiny lots to the surgical team.
    テつ*テつ*テつ*Fourteen million cells dissolved in two drops of fluid were injected into several areas of the patient's injured spinal cord, using a specially assembled surgical device developed by the team and made at Griffith University.
    テつ*テつ*テつ*Spinal research teams throughout the world have recognized the value of using nasal cells for spinal cord repair. The difficulty was in growing cells suitable to transplant from samples taken from patients' noses.
    テつ*テつ*テつ*Although the trial team was careful not to raise false hopes that this procedure will be an immediate cure for paralysis, Dr. Perry said there is a chance that the cells "will do something positive for these people".
    テつ*テつ*テつ*Dr. Licina said he expects some feeling to be regained and possible improvement in bladder and bowel function.
    テつ*テつ*テつ*Dr. Geraghty emphasized that this is a phase I clinical trial , and that much more work is expected before patients will be able to give up their wheelchairs.
    テつ*テつ*テつ*The eight-hour operation was conducted in June, but it is expected to be some months before any changes in this patient's spinal cord will be evident.

  7. #7
    http://www.gu.edu.au/text/er/news/2002_2/02jul12.html

    July 12, 2002

    Spinal Cord Regeneration Project Human Trial Begins

    Phase 1 trial at the Princess Alexandra Hospital: Brisbane, Australia

    In a world first, a clinical trial into spinal cord regeneration surgery in paraplegics has begun.

    Cells, harvested from the nose of a volunteer patient with paraplegia, have been cultured in a laboratory and transplanted into the patient's spinal cord in an eight-hour surgical procedure in June 2002.

    The Queensland Spinal Cord Regeneration Project is a collaboration between Princess Alexandra Hospital (PAH) clinicians and Griffith University scientists, and is supported by a $200,000 PAH Foundation grant.

    This human trial, involving eight volunteer patients, aims to determine the safety of this pioneering procedure and the potential benefits to those who have suffered a recent spinal injury.

    At Griffith University, scientists Professor Alan Mackay-Sim and Dr Francois Feron, have pioneered a method of harvesting and cultivating nerve cells - olfactory ensheathing cells, a type of glial cell - from inside the nose.

    Unlike other cells in the nervous system, these unique glial cells are continually regenerated throughout life by the olfactory mucosa - the nasal tissue responsible for the sense of smell.

    These cells help nerves grow from the nose to the brain and are the only glial cells that can exist both within and outside the central nervous system.

    Princess Alexandra Hospital Spinal Injuries Unit Director, Dr Tim Geraghty, said the glial cells used in the trial would be cultured from cells harvested from each of the volunteer patients.

    "During the intricate surgery, the patient's spinal cord is implanted with his/her own cells, thereby eliminating the risk of cell rejection and the need for anti-rejection medication," he said.

    Dr Geraghty said the aim of the Phase 1 trial was to assess potential risks and determine the benefits to the patients, who have been carefully selected for the trial and have undergone extensive preparation, including physical, psychological, and neurological assessments.

    "The volunteer patients, (test and control groups), will take part in the trial and their progress will be closely monitored by PAH's medical, surgical, and allied health teams for a period of up to three years."

    From the Griffith University School of Biomolecular and Biomedical Science, Professor Alan Mackay-Sim and Dr Francois Feron, have been exploring their methodology and potential application with physicians for approximately two years.

    Dr Feron and Professor Mackay-Sim are internationally regarded as experts in the field of neurogenesis and have been successfully cultivating glial cells in the laboratory in Brisbane since 1998.

    The Phase 1 trial has been approved by ethics committees at the PAH and Griffith University.

  8. #8
    www.health.qld.gov.au/qscis/scrp/press_release.pdf

    Princess Alexandra Hospital Health Service District July 12, 2002
    Spinal Cord Regeneration Project Human Trial Begins Phase 1 trial at the Princess Alexandra Hospital: Brisbane , Australia In a world first, a clinical trial into spinal cord regeneration surgery in paraplegics has begun. Cells, harvested from the nose of a volunteer patient with paraplegia, have been cultured in a laboratory and transplanted into the patient's spinal cord in an eight-hour surgical procedure in June 2002. The
    Queensland Spinal Cord Regeneration Project is a collaboration between Princess Alexandra Hospital (PAH) clinicians and Griffith University scientists, and is supported by a $200,000 PAH Foundation grant. This human trial , involving eight volunteer patients, aims to determine the safety of this pioneering procedure and the potential benefits to those who have suffered a recent spinal injury. At Griffith University, scientists Dr Francois Feron and Professor Alan Mackay-Sim, have pioneered a method of harvesting and cultivating nerve cells テ「窶ーツ* olfactory ensheathing cells, a type of glial cell テ「窶ーツ* from inside the nose. Unlike other cells in the nervous system, these unique glial cells are continually regenerated throughout life by the olfactory mucosa テ「窶ーツ* the nasal tissue responsible for the sense of smell. These cells help nerves grow from the nose to the brain and are the only glial cells that can exist both within and outside the central nervous system.
    Princess Alexandra Hospital Spinal Injuries Unit Director, Dr Tim Geraghty, said the glial cells used in the trial would be cultured from cells harvested from each of the volunteer patients. "During the intricate surgery, the patient's spinal cord is implanted with his/her own cells, thereby eliminating the risk of cell rejection and the need for anti-rejection medication," he said. Dr Geraghty said the aim of the Phase 1 trial was to assess potential risks and determine the benefits to the patients, who have been carefully selected for the trial and have undergone extensive preparation, including physical, psychological, and neurological assessments. "The volunteer patients, (test and control groups), will take part in the trial and their progress will be closely monitored by PAH's medical, surgical, and allied health teams for a period of up to three years." From the Griffith University School of Biomolecular and Biomedical Science, Dr Francois Feron and Professor Alan Mackay-Sim have been exploring their methodology and potential application with physicians for approximately two years.
    Dr Feron and Professor Mackay-Sim are internationally regarded as experts in the field of neurogenesis and have been successfully cultivating glial cells in the laboratory in Brisbane since 1998. The Phase 1 trial has been approved by ethics committees at the PAH and Griffith University. /ends
    Media Contacts:
    Princess Alexandra Hospital:
    Carly Nikolic - 0412 548 872 or 61 7 3240 7899 Jan Leo - 0414 539 080 or 61 7 3240 5701 Griffith University:
    Alexia Deegan - 0408 728 619 or 61 7 3875 6782 Princess Alexandra Hospital Foundation: Gary Evans - 61 7 3240 7301 or 0417 708 655

  9. #9
    http://www.newsweekly.com.au/article...ul27_stem.html

    MEDICAL SCIENCE: Nerve cells used in spinal cord regeneration trial


    by News Weekly
    Printed in Issue:27 July 2002


    Brisbane's Griffith University and the Princess Alexandra Hospital have announced that a clinical trial into spinal cord regeneration surgery in paraplegics has begun in Queensland.

    Nerve cells harvested from the nose of a volunteer patient with paraplegia, have been cultured in a laboratory and were transplanted into the patient's spinal cord in an eight-hour surgical procedure in June 2002.

    The human trial, involving eight volunteer patients, aims to determine the safety of this pioneering procedure and the potential benefits to those who have suffered a recent spinal injury.

    Over recent years, much exploratory work has been done on these cells, called glial cells, which have been found to have an important role in the development and regeneration of the nervous system.

    The experiment rebuts claims that embryonic stem cells alone are suitable for spinal injury, a claim made by actor Christopher Reeve, who became a quadriplegic after falling from a horse.

    Reeve, who played Superman before suffering his injury, has vigorously supported embryonic stem cell research as a cure for spinal cord injury.

    At Griffith University, scientists Dr Francois Feron and Professor Alan Mackay-Sim have pioneered a method of harvesting and cultivating these nerve cells from inside the nose.

    Unlike other cells in the nervous system, these unique cells are continually regenerated throughout life by the olfactory mucosa - the nasal tissue responsible for the sense of smell.

    These cells help nerves grow from the nose to the brain and are the only glial cells that can exist both within and outside the central nervous system.

    Princess Alexandra Hospital Spinal Injuries Unit Director, Dr Tim Geraghty, said the cells used in the trial would be cultured from cells harvested from each of the volunteer patients.

    "During the intricate surgery, the patient's spinal cord is implanted with his/her own cells, thereby eliminating the risk of cell rejection and the need for anti-rejection medication," he said.

    Dr Geraghty said the aim of the Phase 1 trial was to assess potential risks and determine the benefits to the patients, who have been carefully selected for the trial and have undergone extensive preparation, including physical, psychological, and neurological assessments.

    "The volunteer patients, (test and control groups), will take part in the trial and their progress will be closely monitored by PAH's medical, surgical, and allied health teams for a period of up to three years."

    From the Griffith University School of Biomolecular and Biomedical Science, Dr Francois Feron and Professor Alan Mackay-Sim have been exploring their methodology and potential application with physicians for approximately two years.

    Dr Feron and Professor Mackay-Sim are internationally regarded as experts in the field of neurogenesis and have been successfully cultivating glial cells in the laboratory in Brisbane since 1998.

    The trial has been approved by ethics committees at the Princess Alexandra Hospital and Griffith University.

  10. #10
    http://health.iafrica.com/healthnews/994676.htm

    SPINAL CORD REGENERATION
    Spinal cord regeneration trials begin in Australia


    Doctors in Brisbane announced on Thursday they had begun the world's first clinical trial of spinal cord regeneration, using cells from the nose of a paraplegic in a bid to repair his damaged spinal cord.

    They said the first tranplant of the regenerating nasal olfactory cells into a spinal cord was conducted last month by a surgical team at Brisbane's Princess Alexandra Hospital.

    The clinical trial followed experiments at Brisbane's Griffith University and other laboratories around the world in which rats with severed spinal cords were able to move their legs weeks after being transplanted with nasal cells called olfactory ensheathing cells.

    The cells connect the lining of the nose with the brain to provide our sense of smell. Unlike most nerve cells, they continue to regenerate throughout life, a property that probably evolved because they can be destroyed by infections.

    An obstacle to human trials had been that not enough of the cells could be collected from a single individual to patch up a human spinal cord.

    The team at Griffith University led by Alan Mackay-Sim solved the problem by developing a method of removing the nasal cells from a patient under local anaesthetic and growing a large number of the cells in culture.

    For the trial operation, surgeons injected 14 million of the olfactory cells into several damaged regions of the volunteer's spinal cord.

    It is hoped the transplanted cells will provide a bridge to allow spinal nerves to grow through the damaged area.

    Details of the project are also reported in the British journal New Scientist due out on Saturday.

    Gary Evans, head of the Princess Alexandra Hospital Foundation, said the eight-hour operation was an outstanding success.

    "There were actually six or seven sections of the nerves in the cord that they were able to identify as being severed and put the cells directly into that area," he said.

    Three other volunteers are due to undergo similar surgery later in the trial, doctors said. All the volunteers' identities were kept secret.

    Each patient in the trial will undergo a battery of tests to see if there is any improvement in their condition.

    However members of the Queensland Spinal Cord Regeneration Project cautioned the trials were only in their initial stages and involved primarily testing the safety of the surgical procedures.

    "We're not expecting too much at all," said Tim Geraghty, director of the spinal injuries unit at Princess Alexandra.

    "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," he said.

    "If we get some positive outcomes, even better - like feeling coming back in the legs or an improvement in bodily control functions.

    "Even if people could get back some sensation around their bottom and legs, that would be extremely helpful in preventing bedsores. A step up would be an improvement in bladder or bowel or sexual function."

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