First Clinical Trial Approved
The Clinical Research Group of SCSNZ gained approval on 18th Jan 2011 for their first clinical intervention (treatment) trial in people who have chronic spinal cord injury. Noela Vallis, the President of Spinal Cord Society NZ Inc and Dr Jim Faed, the Clinical Research Director for the Society met with the Multiregion Ethics Committee and gained the approval after a long period of 26 months discussion with the Committee and others over this trial. This followed several years of working with the Ethics Committee over other trial proposals.
The Research Team still have several small tasks to complete before the trial will get under way but it is expected that these will be completed in the next 4-6 weeks.
About the Research Trial
The Trial will involve measuring the amount of benefit produced by spinal cord surgery involving a tissue transplantation procedure. Specialised tissue from the upper nose that provides part of the sense of smell will be used. This tissue - called olfactory tissue, has special cells known as OEC’s that provide guidance signals to help nerve fibres grow and to maintain a healthy state. Small amounts of the olfactory nose tissue will be transplanted to the site of spinal cord injury. Before implanting the olfactory nose tissue the spinal cord surgery will be opened at the injury site and much of the scar tissue will be removed. The tissue transplanted will come from the same person so that problems of transplant rejection and spread of viruses will not be present.
This is a first for New Zealand but the procedure to be tested was developed overseas in Portugal and has been performed in several other countries. The previous trials have provided information on safety and risks from the procedure but have not been set up properly to confirm the effects from the treatment. The New Zealand trial is aimed at measuring the amount of benefit obtained.
Previously published studies on this tissue transplantation procedure in people with spinal cord injury have reported some improvements. The amount of benefit in different people has varied. Some have regained sensation and muscle function over several spinal levels below the site of the spinal cord injury. Others have had no benefit. It is expected that responses will be variable in the NZ trial. Recent findings suggest that the type of rehabilitation treatment undertaken is important for determining the amount of benefit.
The New Zealand trial has been designed to measure the effect of the transplantation plus rehabilitation treatment versus rehabilitation treatment alone. This is an important question that can only be answered in a trial that is properly designed and carried out. The trial will run for approximately 2½ years. Volunteers with complete spinal cord injury in the thoracic area will be recruited for the trial. It is the first of what is planned to be a series of trials of treatment interventions in people with spinal cord injury. The goal of SCSNZ clinical trials is restoration of lost spinal cord function. They are not simply aimed at rehabilitation although that will be a supporting part of the trials.
People who wish to take part in the Trial will receive full information about the procedures and the possible benefits as well as details of risks. The detailed information sheet will be available for downloading from the SCSNZ website when the Trial is underway.
The SCSNZ Trial has been supported by donated funds from the Public and Trust funds. Noela Vallis, President of SCSNZ, was delighted to see that news reports of the first trial being approved resulted in a generous donation. A letter in her mail two days after the Press announcements contained a cheque for $1,000 from a farmer who ‘wanted to help’.
It was down to earth practical donations for a practical trail! It was just so touching says Noela Vallis of this donation. Many hundreds of people have given spontaneous support for the Society’s work over the last twenty years. You are all included in my thanks for your support, said Noela Vallis.
The Research is also supported by donations obtained from large Trusts in NZ. The Lion Foundation has been a major supporter and we have received continuous support from The Perry Foundation, The Southern Trust, Pub Charity, Rotary clubs and The Women’s Institute for many years. In 2006 we were also helped by the French Spinal Cord Trust – ALARME (Independent Association Supporting Spinal Cord Research). They have promised more support when the first Trial was approved.SCSNZ will continue to ask people in NZ for help with funding as the series of trials and the laboratory research planned will need active support for many years yet.
Click Here to download an application form to be involved in trials! please note that acceptance is not automatically guaranteed and is for NZ Citizens only at his time.
A medical team in Ecuador, using methods in some ways similar to proposed New Zealand trials, has achieved for all of the eight people confined to wheelchairs, improvement in muscle function and feeling.
Some have regained ability to walk with assistance.
The report just received by the Spinal Cord Society of New Zealand (SCSNZ), describes the clinical trial of spinal cord injury treatment.
The trials used the patients’ own bone marrow cells and patients received the treatment over the past 15-24 months.
Four of the patients in the trial had chronic spinal cord injury and had been paralysed and confined to wheelchairs for periods of between 6 to 22 years and four had recent spinal cord injuries. People with chronic spinal cord injury do not normally show any improvement after 1-2 years but those with recent injury can show moderate improvement in the first year after the injury.
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