New Zealand stem cell trial gets green light
http://tvnz.co.nz/health-news/nz-stem-cell-trial-gets-green-light-4001304
Ethics experts today gave approval for the country's first clinical trial using adult stem cells to treat people with spinal injuries.
A dozen people now confined to wheelchairs will later this year have stem cells from inside their nose injected into the site of their spinal injuries.
"We will be contacting GPs in bigger centres such as Auckland, Hamilton, Wellington, Christchurch and Dunedin asking if they have any people with spinal injuries on their books who may be suitable that they may want to approach, and also getting in touch with spinal injury networks," said Otago Medical School haematologist and cell biologist Jim Faed.
New Zealand has about five thousand people in wheelchairs due to spinal cord injuries - and at least one person a week joins them after an accident - but Dr Faed said only a dozen paraplegics will be accepted for the trial, and only half of those will actually receive stem cells.
Six people will have the surgery while the other six will just go through the intensive rehabilitation and be the control - or placebo - group to benchmark the effects of the stem cells.
Paraplegics whose injury occurred between two and seven years ago will be considered. .
The Spinal Cord Society president Noela Vallis said the long-term aim was for a cure but the initial trial would only aim to improve sensation or function for the participants.
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Vallis and her husband Keith started the SCS about 25 years after he became paralysed.
Vallis died six years ago from complications surrounding his original injury, but Valiss continued the project and for the past four and a half year has been seeking ethics approval for the trial.
She said four years ago that the same operation had 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.
This had included recovering bowel and bladder-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."
Today she said the society had submitted data to the ethics committee at least 10 times.
"It was a very frustrating process," she said. "The trial is safe."
She was pleased that the trial was finally going ahead: "We are really ecstatic, it couldn't be better news for people with spinal injuries in this country.
"A lot of people say we are just giving false hope - but these people are sitting in wheelchairs and already have no hope."
The aim of the trial was to prove it was safe and that patients benefited.
"We will keep going until we get a proper cure," Vallis said.
Dr Faed was at today's multi region ethics committee meeting and said most members voted in favour of the trial, but there will be further paperwork to be signed off, including an assessment of a Dunedin hospital where potential trial participants will be screened over the next four to six weeks.
The screening will be carried out in Dunedin, the surgery will be done in a private Christchurch hospital, and then each patient's rehabilitation will be done in his or her local city.
The whole trial will take about two and a half years.
Dr Faed said a lot of time and money had been wasted on the ethics approval process, and it was important that people realised the process involved adult stem cells and not the stem cells controversially taken from human embryos.
"I am just pleased we have finally got to the trial stage and never imagined it would take so long to get approval, but I was never going to give up," he said.
Stem cells taken from mouse embryos have helped paralysed rats move again, and US doctors last year began treating a patient with new spinal cord injuries with human embryonic stem cells taken from human embryos left over from fertility treatments
http://tvnz.co.nz/health-news/nz-stem-cell-trial-gets-green-light-4001304
Ethics experts today gave approval for the country's first clinical trial using adult stem cells to treat people with spinal injuries.
A dozen people now confined to wheelchairs will later this year have stem cells from inside their nose injected into the site of their spinal injuries.
"We will be contacting GPs in bigger centres such as Auckland, Hamilton, Wellington, Christchurch and Dunedin asking if they have any people with spinal injuries on their books who may be suitable that they may want to approach, and also getting in touch with spinal injury networks," said Otago Medical School haematologist and cell biologist Jim Faed.
New Zealand has about five thousand people in wheelchairs due to spinal cord injuries - and at least one person a week joins them after an accident - but Dr Faed said only a dozen paraplegics will be accepted for the trial, and only half of those will actually receive stem cells.
Six people will have the surgery while the other six will just go through the intensive rehabilitation and be the control - or placebo - group to benchmark the effects of the stem cells.
Paraplegics whose injury occurred between two and seven years ago will be considered. .
The Spinal Cord Society president Noela Vallis said the long-term aim was for a cure but the initial trial would only aim to improve sensation or function for the participants.
Advertisement
Vallis and her husband Keith started the SCS about 25 years after he became paralysed.
Vallis died six years ago from complications surrounding his original injury, but Valiss continued the project and for the past four and a half year has been seeking ethics approval for the trial.
She said four years ago that the same operation had 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.
This had included recovering bowel and bladder-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."
Today she said the society had submitted data to the ethics committee at least 10 times.
"It was a very frustrating process," she said. "The trial is safe."
She was pleased that the trial was finally going ahead: "We are really ecstatic, it couldn't be better news for people with spinal injuries in this country.
"A lot of people say we are just giving false hope - but these people are sitting in wheelchairs and already have no hope."
The aim of the trial was to prove it was safe and that patients benefited.
"We will keep going until we get a proper cure," Vallis said.
Dr Faed was at today's multi region ethics committee meeting and said most members voted in favour of the trial, but there will be further paperwork to be signed off, including an assessment of a Dunedin hospital where potential trial participants will be screened over the next four to six weeks.
The screening will be carried out in Dunedin, the surgery will be done in a private Christchurch hospital, and then each patient's rehabilitation will be done in his or her local city.
The whole trial will take about two and a half years.
Dr Faed said a lot of time and money had been wasted on the ethics approval process, and it was important that people realised the process involved adult stem cells and not the stem cells controversially taken from human embryos.
"I am just pleased we have finally got to the trial stage and never imagined it would take so long to get approval, but I was never going to give up," he said.
Stem cells taken from mouse embryos have helped paralysed rats move again, and US doctors last year began treating a patient with new spinal cord injuries with human embryonic stem cells taken from human embryos left over from fertility treatments