Similar trials intended to start in New Zealand

(New Zealand has over 5000 people confined to wheelchairs resulting from spinal cord injuries)

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.

All of the patients showed improved results in assessment of their quality of life.  Improvement in control of bladder function also occurred
in some patients.

Noela Vallis, Chair of the New Zealand Spinal Cord Society, said the Ecuadorian trials used the patients’s own bone marrow cells,
and SCSNZ has been developing plans for related trials in New Zealand. 

“However, our trials will begin with use of the patient’s own olfactory mucosa (cells taken from the upper nose) and later with addition of trials using their own bone marrow cells,” she said. Ms Vallis said the Society has received heavy inquiries since it announced the planned New Zealand trials last week. She has asked that people in wheelchairs email Dr Faed rather than call. “He has become a bit overwhelmed by calls for people wanting to volunteer for the trials,” said Ms Valllis.

“The evidence for this concept of using the patient’s own cells, is becoming so compelling now that we are sensing an impatience to get on with it,”
she said.

The Society places its final submission to the Multi Regional Ethics Committee on April 21 and once final approval is received, the trials will get under way.

The Society also needs to raise $2million as quickly as possible, to fund the trials and subsequent rehabilitation programmes. Ms Vallis said she is confident that many of the 5000 New Zealanders confined to wheelchairs will soon experience a dramatic improvement in their quality of life.

Ms Vallis said donations for the trials can be made by:

• telephoning 0900 spine ( 77463),
• by going on line to the Society’s website
• or by depositing funds at any branch of the Westpac bank

New Zealand doctors are on the verge of getting approval for cutting-edge surgery that could help the paralysed feel or even walk again.

TVNZ News 18/03/2009

The experimental procedure, which has only been attempted in a few countries, uses the patient’s own stem cells to try to repair the severed spinal cord.

Some say the procedure will offer a ray of light for the paralysed, but others warn the procedure is still in its early stages to be sure.

Scientists have been working on this project in a purpose built lab for the past six years in New Zealand, growing cells from human bone marrow.

But in patient trials they will be using what’s called olfactory cells, from high up in the spinal patient’s own nose.

They are the only nerve cells in the body which continually replace themselves.

Dr Jim Faed, the clinical research trial leader, says there can be regeneration and repair in the spinal cord induced by those cells.

Pending final ethics committee approval, doctors will recruit 12 spinal patients for phase one surgical trials at Dunedin Hospital.

It’ll be a two-stage surgical process, using the patients own adult stem cells.

In the first stage, one surgeon will remove slivers of cell tissue from the patient’s nose.

Then a neurosurgeon will open up the patient’s spine and re-plant those cells into the spinal cord injury site. Results would take months to show.

Caution sought

But Faed is cautious about the results of the trial.

“Are patients going to get up and walk a month later? No, that’s not going to happen, it’s not that dramatic,” says Faed.

A team in Portugal has already carried out over 100 such operations.

Dunedin neurosurgeon Grant Gillett has flown to Lisbon twice to observe the surgery and patient recovery.

“It led me to believe that there was some measurable benefit, it was subtle, but it seemed measurable,” says Gillett.

Clinical trials on 69 patients have shown no major adverse side effects, aside from post-operative pain.

One or two have reportedly regained movement down to thigh level, while others have regained limited bowel and bladder function.

But doctors concede most have had only slight improvement and some none at all.

“This is an experimental procedure. If you had it, the people doing it for you could not guarantee you any benefit,” says Gillett.

Those who are sceptical of the procedure, like Dr Shaun Xiong, who heads the Burwood Spinal Unit in Christchurch, has concerns that it’s just too experimental.

The Burwood Spinal Unit specialised in spinal injuries for a nation that is rated as leading the world in spinal injuries, where one person is paralysed every five days.

“I believe at this stage the science is not quite there for the clinical trial, particularly if people jump in and offer it as a treatment option,” says Dr Shaun Xiong, of the Burwood Spinal Unit.

He also has concerns Dunedin Hospital doesn’t have the expertise to treat spinal patients.

But one of the patients at Burwood thinks otherwise.

Courtney Edmonds, a tetraplegic patient, who has been paralysed since a car accident four years ago, is supportive of the procedure.

“I think just to be able to move my fingers again would mean far more to me than actually walking,” says Edmonds.

Courtney says any risk is one he’d be prepared to take.

Noela Vallis, of the NZ Spinal Cord Society, says the procedure may have its benefits, as she believes there are too many people suffering who don’t have to.

Vallis set up the NZ Spinal Cord Society, which now has its own research lab at Otago University.

But the green light has yet to be given for the procedure and the decision is still being mulled over.

The Regional Ethics Committee has given conditional approval but is meeting next month to consider giving final approval.

If that’s granted, a fundraising campaign will be needed to fund the first 12 operations.

Then they’ll start recruiting patients, looking first for patients with thoracic spine injury that’s chest height before the first operation at Dunedin Hospital hopefully by mid-year.

As with all phase one clinical trials, the first operation is purely to establish if it’s safe and whether there is any benefit to be gained.

 Source: TVNZ

New Zealand is poised to take a major step towards people in wheelchairs, taking their first steps again.

Clinical trial operations on the first twelve New Zealanders with chest/stomach level spinal injuries, are scheduled to begin this year.

The Spinal Cord Society of New Zealand, a charity which has been funding research into cells that have shown potential to repair spinal cords, has conditional approval to start the trials on volunteer New Zealanders with spinal injuries

The Society will submit additional information requested to the April 21 meeting of the Multi-Region Ethics Committee in Wellington and is confident of receiving full approval, ending an effort of almost three years to satisfy the requirements of the Ethics Committee.

In the meantime, other programmes overseas have convinced a growing number of medical experts that an effective treatment for spinal cord injuries is getting much closer.

The procedure to be applied in New Zealand has been carried out overseas in countries such as Portugal, Italy, Japan and China on well over 100 people with few negative side-effects and varying degrees of improvement for each patient that has included bowel and bladder re-function, through to extra feeling and movement in limbs.

“The results are widely varied in different patients, but an important factor is that there have been few negative side-effects,” said Noela Vallis, Chair of the New Zealand Spinal Cord Society.

The procedure involves extracting tissue from a volunteer’s own olfactory tissue in the nose and inserting this into the injured area of the spinal cord.

Ms Vallis said the procedure offers no controversy over the source of cells because it involves a transfer of  the patient’s own cells.

“It’s similar to a skin graft, so there is no need for complex anti-rejection drugs,” she said.

Ms Vallis  said there is high level of  positive international interest in the research the society has been doing at its laboratory at the University of Otago Centre for  Innovation with the staff of Otago Medical School.

“While doctors in other countries have actually made a  start with these  procedures, we have made use of the delays here, to continue studying the behaviour of human cells in our lab,” she said.

“We are probably ahead of other countries in this knowledge,” she said.

Dr Jim Faed, the cell biologist and haematologist who manages the Society’s research programme and who will lead the clinical research team to undertake the trial operations, said there is still much to learn about the cell behaviour.

“The clinical trial we have planned, and the expected future trials, will help advance that understanding,” he said.

“There is a high level of confidence among the medical team, that our first trial is the right step to take in moving to human research. The trial will go further than research overseas and collect important information about the mechanisms for improvement,” he said.

Dr Faed said if the operations confirm results found overseas while clarifying other key points identified by the clinical research team, the team will be well placed to carry out trials of enhanced procedures.

Fundraising challenge

Another major hurdle the Society needs to overcome is a $2 million budget for the trials over the next year or more.

Ms Vallis said funds have been promised from a number of sources but essentially the society has no Government backing.

“We will need to attract community backing. We have set up a website and an 0900 donation line,” she said (0900 SPINE or 0900 77463)

“We are poised to bring possibly the greatest medical breakthrough in a century and we are doing it as a charitable organisation,” she said.

The Society was formed by Ms Vallis in 1991 when she decided to seek a cure for her late husband’s spinal injury. Following  his death she has continued to lead the Society’s effort.

“I might be in my seventies, but I now believe it will be in my lifetime that people will go into hospital with a spinal injury and walk out weeks or months later just as though they’d experienced a broken leg,” she said.

“We will do all we can to ensure the knowledge we have gained, can be available to New Zealanders as soon as possible. But we will need financial support,” she said.

ENDS

For further details:

Email tony@tonyedmonds.com

OR call Noela Vallis on 07 888 1728

OR call Dr Jim Faed on (03) 470 9364 mobile 0275 404 836