Lobbyists anxiously await stem cell trial decision
ROBERT STUBBS is a Gisborne forestry contractor with one aim in life – to walk again. He has been paralysed from the chest down since he was hurled from his motocross bike on an uneven surface four years ago.
The 37-year-old finds it awkward to turn over in bed at night, urinates through a catheter, and gets frustrated about how long it takes him to get dressed sitting in his wheelchair every morning.
After spending months in the Burwood Spinal Unit in Christchurch following his accident, he returned home and to forestry, but it's a struggle. He uses a winch to get up into the bulldozers and diggers that he operates with hand controls.
Stubbs wants to be a participant in a proposed stem cell trial and is willing to take the risk that he might die if something goes wrong. "I'm tied to this wheelchair so what have I got to lose? It is a sentence that none of us asked for or wished for."
However, the proposed clinical trial on a handful of New Zealanders with spinal injuries is unlikely to be approved by the Ministry of Health's Multi-region Ethics Committee when it meets in Wellington on Tuesday. It's been knocked back more than 10 times in less than five years.
Spinal injury specialists can't agree on whether the trial would be worthwhile or would just create false hope. Many scientists and doctors see it as a waste of money.
The surgery, which involves adult stem cells taken from the participants' own noses, has apparently shown some promise in several countries and there's a call for it to be undertaken here.
Over the past four and a half years the Spinal Cord Society, a charity funded solely by donations – including half a million dollars from the Lion Foundation – has been seeking approval for such a trial but been turned down regularly. It was founded by Matamata resident Noela Vallis and her husband Keith, who was in a wheelchair for decades before passing away six years ago from complications surrounding his spinal injury. They set up the society 25 years ago with the motto "Cure – Not Care", and since Keith's death, Noela has become even more determined that the stem cell trial will go ahead.
The 70-year-old is eager to point out that the stem cells come from the trial participants' noses and are not embryonic or from a donor (see sidebar, page C2). She talks with passion about her cause, explaining that the trial could begin straight away at a private hospital in Christchurch, involving about a dozen paraplegics who would have stem cells taken from their nasal tissue and inserted into their damaged spines.
"This trial will go ahead – I assure you this trial will go ahead. We will protest throughout the country if it doesn't. It's not too soon to do trials on humans."
Vallis says a team of skilled doctors and scientists is committed to the trial and has been working towards it for five years.
The society hopes their work will show whether nasal stem cells can differentiate into spinal cord cell types in humans. Vallis claims similar trials in Portugal have had varying degrees of success and that some people with spinal injuries have gained more sensation, better bowel and bladder control and even increased movement.
New Zealand has a very high rate of spinal injuries, she says, and there are currently about 5000 wheelchair users who not only struggle through life but cost the health system more than $300 million a year in rehabilitation and support.
"Our trial is not false hope, because these people have no hope to start with, and we intend to improve this. About 300 paralysed people have been done worldwide with their own stem cells and nobody has died. It is safe and some have gained more bodily functions."
However, she acknowledges that there is a risk, as with any surgery.
Vallis says continual calls for more research are wrong.
"It is a human rights issue and I will take it to the Human Rights Commission as it's people's right to have access to this treatment. It is frustrating for people in wheelchairs with pressure sores and coping in this heat. To help people, we are morally obliged to do it."
Vallis is sick of being told that more testing on animals is needed.
"I don't give a hoot about various specialists who say we shouldn't be doing it. Scientists have been doing trials on rats for the last 40 years. You will not get results by continuing to do research on rats for the next 40 years!"
HOWEVER, MANY doctors and scientists are adamant the trial would not work, and want to continue with research on rodents. Dr Rick Acland, a former medical director of the Burwood Spinal Unit in Christchurch and a current member of the Medical Council, says, "These trials could do more harm than good and there is an Auckland paraplegic who nearly died after going for similar treatment in a South American country."
Acland says the man developed meningitis and spent a long time in intensive care when he came back to Auckland last year. He was then transferred to a neurological ward and Acland says he is worse off than before he had the treatment.
"It is very sad, a tragedy. This is a vulnerable group of people and some are desperate for a cure so will take risks. I understand that."
But Acland says it is naive for a group of local scientists and doctors to think that scraping out the lining of someone's nose and transferring it into their spine will somehow lead to functional improvement.
"It is bizarre as I have looked at it for the last decade and, apart from placebo effect, it doesn't work."
Last October Acland went to New Delhi to attend the International Spinal Cord Society's annual scientific meeting. "I was updated about what's going on and a lot of interesting work is ongoing in the animal laboratories but sadly, there have been very few world clinical trials of any repute. There has been no clinical evidence forthcoming to show improvement in spinal cord injury outcomes."
Acland describes expensive overseas trips for treatment as "stem cell tourism". He says one such place in Germany is about to close because of the death of a teenager who went there for treatment and developed a tumour. "Why would New Zealand want to embark on this project?" he asks.
Asked what he has to say to paralysed people about their future, Acland responds, "These are people who have redirected their lives. Sure, it is life after `bugger'. But it doesn't mean you won't have a rich and rewarding life. However, at times it must be hell."
It is that hell that the current medical director of the Burwood Spinal Unit wants to help change, so he is part of the medical team involved in the proposed trial.
Dr Xianghu Xiong says he supports appropriately designed clinical trials – and this will be one, if it is approved – but admits he wouldn't be surprised if it is rejected. Xiong has travelled to China to observe similar clinical trials and the post-operative care the participants receive.
"We will explain to the patients that the trial is very preliminary at this stage so they have to consider it with extreme caution. I don't think the patients will be led to believe in false hope as they will be fully informed beforehand. I am totally happy with a negative outcome if that is the case."
No one will make a profit out of the attempt, Xiong says.
"We need a trial that is not biased and nobody has convincing evidence to say it won't work. It's about being open-minded and trying to make a difference."
TWO YEARS ago, Robert Stubbs travelled to China for stem cell treatment that cost about $50,000 and didn't work.
"China appeared to have some sort of success and I didn't expect to be able to walk out but was looking for some sort of improvement such as sensation or bladder control," he says.
Stubbs says the cells came from donated umbilical cords, and treatment at the Cheng Yang hospital started with a couple of injections into his blood stream, then four lumbar injections below his injury site. "They did one injection a week and each day I had electric wave therapy which was trying to get some muscle tone in my legs, as well as acupuncture."
Stubbs says when the injections started some feeling returned down his chest, but he was told that this could be from the growth hormone that was included with the umbilical cells. After a few weeks back in New Zealand, that sensation disappeared.
"During the treatment I got an infection from one of the jabs but that was nailed with antibiotics. I did rush into it pretty quickly as I was still fresh from my accident but am happy that I did and blew money on it as I would have been sitting here, wondering if it may help, and I learnt a lot."
Despite the setback, Stubbs wants to put his name forward for the proposed local trial and says that doctors who are opposed to it should try living in a wheelchair. He believes the Spinal Cord Society's trial would be as good as any in the world and thinks the Multi-region Ethics Committee should just get over the issues and approve it.
"This is not what I had planned for life, and I sometimes wish I was dead anyway so if I died in the trial then hopefully in the future those who go on to have the treatment benefit from me and walk again."
But even among wheelchair users there is disagreement. Kim Hudson is a 29-year-old who became a paraplegic about 15 years ago in a hit-and-run while she was walking along an Auckland footpath. "I wouldn't do the trial as I don't want to be a guinea pig and part of a potential muck-up."
Hudson says there has not been enough research, and believes a human trial would be premature. "I don't think it is quite at the stage where people should be volunteering their bodies. It would take someone having a full recovery before I would take part, as I'd need to know they are not just tinkering about like an amateur mechanic."
Hudson has resigned from the Otara spinal unit where she was a service co-ordinator and is looking at studying business at university this year. "At the spinal unit it always came up in conversations with patients, and we didn't recommend stem cell treatment of any type at all. Ultimately it is someone's own decision but, given how much trauma their bodies have already been through, is it worth doing even more?"
She believes the risks are too high and doesn't want her body "messed up" even more than it already is.
The country's leading stem cell research team, at the Auckland Medical School, agrees and advises caution.
Associate professor Bronwen Connor, who leads the neurogenesis laboratory in the Centre for Brain Research, says the only genuine stem cells come from embryos, not adult cells that are already "formatted" to repair particular parts of the body where they are located.
Connor, who is also a member of the Neurological Foundation's scientific advisory committee, says money for research and trials is tight, and she believes human trials with nasal cells are premature. "If you put mature olfactory cells from someone's nose into their spine, they won't know what to do and sure, people may get increased sensation, but that sensation could be pain."
Connor says the science is incredible, but still in its early days and involves cells that no one yet knows much about. "It may appear that we are proceeding very slowly and cautiously but we need to know the benefits and risks, as once the stem cells are transplanted they can't be removed if things start going wrong. It's not like a tablet that you can just stop taking if there are side-effects."
Connor adds that if the trial goes ahead, participants must realise they are unlikely to walk.
The chairman of the Multi-region Ethics Committee is lawyer Richman Wee, who says he can't comment about issues people have with its decision-making process apart from saying it goes through "due process" with every application. Wee says the committee is almost ready to make a final decision about the proposed nasal stem cell trial.
What do you think about a stem cell trial for paralysed New Zealanders? Email email@example.com.
Sunday Star Times