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Call for paralysed participants in clinical trial

| Source: voxy.co.nz

A pioneering treatment for people paralysed with spinal cord injuries is now in the early stages of a clinical trial in New Zealand. Paralysed people with spinal cord injuries are being called to take part.

The clinical trial is the first of its type in the world. It is also the first of several trials that are being planned by the Spinal Cord Society of New Zealand’s team of doctors and scientists.

Approval to conduct the first clinical trial has been approved for the public by the required medical authority in New Zealand, the Multiregion Ethics Committee.

This clinical trial will be based around a process called OMA (olfactory muscosal autotransplantation), which involves taking adult olfactory cells from the roof of the nose of a patient and applying them to their spinal cord injury site. Each surgical procedure will take about four hours. The trial also involves an active physiotherapy programme and regular monitoring of progress.

The Spinal Cord Society of New Zealand (SCSNZ) is behind the trials that will be directed by Dr Jim Faed from SCSNZ’s clinical research laboratories in Dunedin.

“The procedure has been used previously in other parts of the world with sensory improvements and improved muscle function for some patients. This will be the first comprehensive clinical trial on OMA anywhere in the world and will measure how much benefit is obtained by comparing two groups of people with spinal cord injury.

“What makes our clinical trial a world-first is the comprehensive. two years of follow-up and physio each patient will receive, which has never before been included in similar clinical trials. Additionally, our team of doctors and other experts assisting in the trial is extremely broad, which is another unique aspect of this trial,” says Dr Faed. This trial is about “taking the first steps” to beating spinal cord injury. It is needed to start making progress in treatment.

As well as getting ready to launch the clinical trial, SCSNZ needs to complete the necessary fund raising to ensure the trial can go ahead.

SCSNZ president, Noela Vallis of Matamata, says although the trial is only a first step in developing a potential cure, it is a constructive step forward for some people in wheelchairs with spinal cord injuries.

For the past 20 years, Noela Vallis of Matamata has campaigned and fund-raised for research that gives hope to people with spinal cord injury – that they may have improvement in the severity of their paralysis.

“I’ve always believed in a cure ahead of care. However if we don’t keep on pushing to find a cure then it will never come. This is a medical science, research based procedure and it just may provide the result that we are looking for in the long-term,” she says.

It is expected that the clinical trial will take two years to complete. Dr Jim Faed says, “The people who take part in this trial will be investing in their long-term future; they will start the scientific progress that has been missing for so long. Many of these people will probably come back for further treatment in future as even more advanced methods are developed. For people with spinal cord injury this is the ultimate investment.”

Currently New Zealand spends more than $100 million each year through ACC and hospital care and long-term support for people with spinal cord injury. The real cost to the society is much higher than this through lost opportunities for affected people, chronic health problems and the personal costs for affected people and their families. The Spinal Cord Society NZ research program aims to turn this around so that effective treatment becomes available and paralysed people are cured.

New Zealanders can now help to turn this scene around by donating to SCSNZ research and clinical trials.

SCSNZ is currently working to raise the final $1 million required to enable the trial to get underway which is planned for the first half of 2012. The trials are all paid for by SCSNZ through its own funding-raising efforts. Currently there is no government funding available for the trials.

Up to 12 people with a very specific type of spinal cord injury are currently being sought for the trial. The requirements include:

People with “complete” thoracic level spinal cord injuries (which is defined as having an absence of motor and sensory function below the level of the spinal cord injury). Only a minority of patients have this type of injury as the thoracic spinal cord is protected from injury by the structure of the rib cage.

Those people aged between 18 and 35.

People who received their spinal cord injury between two and seven years ago.

People who would like to participate and believe they may fit the selection criteria are asked to contact the SCSNZ Clinical Research Team enquiries@scsnz.org.nz or phone 03 479 5858. Additionally, information and donations can be made online at www.scsnz.org.nz .

Jim Faed

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