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Private stem cell clinics branded 'questionable'

Private stem cell clinics branded 'questionable' amid calls for licensing

Karoline Tuckey, Journalist

Private clinics offering tantalising hopes from stem cell treatment are being accused of taking advantage of desperate patients and exposing them to risks.

A colony of human embryonic stem cells (at centre). Photo: Ryddragyn via Wikipedia

New Zealand's public health system has offered stem cell bone marrow transplants for cancer patients for many years, but a collection of private clinics have also sprung up offering expensive stem cell treatments to patients suffering joint problems and sports injuries, auto-immune diseases and neurological problems.

The clinics extract a small amount of each patient's body fat, from which their own stem cells are taken, before being put back into their body.

Through this, they claim to treat everything from Parkinson's disease and multiple sclerosis, to musculo-skeletal problems and erectile dysfunction - and it's not cheap, costing up to $18,000.

Otago University medical lecturer and stem cell researcher Jim Faed said while this was an exciting area for study, there was no strong evidence the treatments on offer actually cure disease - although he had heard of patients experiencing some pain relief.

"This is early phase, it should still be in research under research trials, and the method needs to be improved.

"When we come to the private clinics, we see something that is not nearly as controlled - it isn't as subject to clinical trials or scientific research, and I think it has jumped far too quickly."

He said it was a case of buyer beware, and New Zealand regulations had yet to catch up.

"These should be licensed as medicines, they must go through a licensing process, which validates that they can achieve the goals that are actually claimed. At present there's too much smoke and mirrors. It's not something that I would recommend."

A Ministry of Health spokesperson said New Zealand didn't specifically provide regulations for stem cell therapy, where the cells came from the patients' own body.

It is "likely" the treatments fall under Section 25 of the Medicines Act, allowing the prescription of unapproved medicines, where patients are clearly informed about the risks and benefits of the treatment.

However, "Autologous stem cell therapies for arthritis and other joint conditions have a weak evidence base and should not be offered to patients outside of a properly conducted clinical trial with full ethical approval," they said.

In April the ministry closed consultation on a new Therapeutic Products Bill, that would create rules to regulate treatments using tissues and cells.

The ministry will soon report the findings to government, and the bill is expected to undergo more technical and policy work before being introduced in parliament, and from there could progress to a select committee.

New Zealand-based clinic ReGen Cellular has backers from Melbourne's Monash University's academic staff, and operates from Ormiston hospital in Auckland.

The clinic's general manager Emma Hart said their treatment was based on a scientific trial, and they would welcome new regulations.

"There are questionable clinics out there doing questionable things," Ms Hart said.

"They don't have a million dollar lab. We do. They don't offer any certainty on what they are pumping into people. We do.

"This is not snake oil. This is new tech, new science that traditional health professionals are largely uninformed about. They will catch up over time and as more and more studies are released."

Dr Joanna Romanowska offers stem cell treatment from Clinic 42 in Auckland, and said there was strong evidence for the new therapies in veterinary science. Medical trials, however, had been slow to come because it was difficult to find funding for big studies because the treatment does not support a drug or device that could become intellectual property.

But she said that did not mean the treatments were ineffective, and she believed the evidence was mounting.

Sydney University legal professor Cameron Stewart led a team of medical and legal experts who studied the clinics in Australia and made recommendation before regulations there were tightened. The investigation was launched after the number of clinics there "exploded" from 14 to more than 70, he said.

"If that's an indication of demand, then there seems to be increasing demand and an increasing number of services being provided."

He said different clinics offered a range of different stem cell treatments, with no evidence that what was being provided in each clinic provided any therapeutic effect.

In Australia providers must now operate from hospitals, where they are overseen by ethics committees, or offer proof their treatment is effective in providing the benefits they claim.

"The language was very brave, they were actually saying there was evidence for things when there wasn't ... they've toned the language down and ... [now] they ultimately don't make any promises that these things work.

"But I worry ... because the patients are very desperate sometimes, and they don't hear that. They're not in a position to hear the risks, they really want to go forward, because they don't have any other options from traditional medicine."

He said widespread use of the term "treatment" to describe the procedures carried ethical difficulties.

"The term treatment does come with value, it has a presupposition that what's being done to you has a therapeutic basis."

He said there was also the risk patients seeking help from private clinics could delay seeking other proven treatments or stop their prescribed medications, and there was a wider social drawback, as it could divert them from taking part in rigourous clinical trials that contribute to our knowledge about them.

Multiple sclerosis patient and registered nurse Anne Besley was approached by a New Zealand stem cell clinic offering her treatment following a fundraising drive to travel overseas for a different treatment.

She does not believe there is evidence the treatments available in New Zealand could treat MS, as well-regarded and promising trials overseas depend on chemotherapy to knock out the malfunctioning immune system that attacks MS sufferers' nervous system - and that is not offered by stem cell clinics here.

Ms Besley said it could be difficult for patients to navigate the mountain of information for all the treatments on offer when they are struggling with a serious illness.

"You are so overwhelmed, you are so ill, and you are so fatigued. It's very, very difficult - the best thing that I can say is to use the direction of your doctor, and things like the Multiple Sclerosis society - they'll tell you what the reputable sites are for information."

Parkinson's New Zealand's clinical director said the unproven "miraculous therapies" exposed patients to the risk of harm and side effects, and Auckland University Medical School lecturer Dr Bronwen Connor has previously warned they carry potential danger.

In the US the FDA has warned some providers are "unscrupulous", and stem cell treatments are responsible for a patient becoming blind, and another developing a spinal tumour.

In Australia a woman with dementia being treated with stem cells in 2013 bled to death after the doctor did not ensure she had stopped taking blood thinners. http://www.coroners.justice.nsw.gov.au/Documents/Findings%20Drysdale.pdf

The coroner Hugh Dillon said while "all medical and surgical procedures necessarily start off experimentally, there is a world of difference between rigourously and ethically-conducted clinical trials that are reviewed at every stage by qualified peers", and this procedure which, in relation to treatment of dementia at least, has some of the troubling hallmarks of "quack" medicine.


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