Stem cell medicine has huge potential but unscrupulous clinics offering unrealistic hopes are endangering its future
Excitement about cures for diseases like multiple sclerosis has led desperate families to poorly regulated clinics peddling ‘untested therapies’, say scientists in the Lancet. Photograph: Rafe Swan/Getty Images/Cultura RF
The credibility of stem cell research is at risk because of
charlatans and dodgy clinics peddling unproven cures for diseases, according to
a group of eminent scientists in the field.
Stem cell research, or regenerative medicine, has great
potential and has already delivered some breakthroughs, but its future is
threatened by poor science, unrealistic hopes, unclear funding models and
unscrupulous private clinics, they say in the Lancet medical journal.
A special Lancet
commission made up of leading experts has reviewed the progress to
date in a field that was once thought to offer answers potentially to all forms
of disease and disability. If it is ever to move from small-scale experimental
treatments into mainstream medicine, “substantial rethinking of the social
contract that supports such research and clinical practice in the public arena
will be required,” they say.
Huge excitement about possible treatments for incurable diseases
like multiple sclerosis and Parkinson’s disease, inflated by media reports, has
led desperate patients and families to a proliferating number of poorly
regulated clinics peddling “untested and potentially ineffective therapies”.
“The great risk of the current situation is highlighted by the
case of Vannoni in
Italy, in which the Stamina Foundation initially succeeded in obtaining direct
authorisation from the Italian government to administer an unproven therapy to
patients, thus bypassing the country’s regulatory authorities,” says the
report.
In March 2015, David
Vannoni was convicted of conspiracy and fraud for administering
unproven stem cell therapies to patients at his Stamina Foundation. Vannoni,
who was not trained as a scientist or doctor, claimed that bone marrow cells
could be converted to neural cells to cure diseases such as Parkinson’s
disease, muscular dystrophy and spinal muscular atrophy.
The Italian Medicines Agency tried to shut down Vannoni’s
operation in Brescia hospital in 2012, but parents of sick children with
devastating and terminal illnesses went to court demanding stem cell treatments
and hundreds of them won. The Italian government agreed in 2013 to fund a $3.9m
clinical trial of the therapy. It took years of campaigning and investigation
by scientists to expose Vannoni’s claims. He was sentenced to 22 months in
prison, suspended on the condition he ceased treating patients.
Is there scientific documentation of the work they are offering
as a basis for therapy? If not, that is a matter for concern
“It happens all over the world, including the United States,”
said cell biologist Prof Giulio Cossu from the University of Manchester, who
led the commission. “It is no longer the case that you go to India or China.”
It is hard for patients and parents to know whether a stem call
treatment that is being offered has any validity but, said Cossu, there are a
few simple rules. “Firstly, is the website showing any publication? Is there
any scientific documentation of the work they are offering as a basis for the
therapy? If not, that is a matter for concern.
“Second, they should give information on the cell type. They
often say ‘stem cells’ with no information if they come from a donor or the
patient or a bank. And you need a specific cell type for a specific disease.
“Thirdly, is there follow-up? How are patients doing after five
years? What proportion of their patients are responding?”
Unfortunately, he said, many of the websites are selling hopes,
not drugs.
There have been some real successes, such as bone marrow
transplants for babies born with damaged immune systems who would otherwise
have died. There are two areas in which stem cell treatments work well – in
diseases of the blood and the epithelia, or skin. The reason is that it is
possible to remove all the diseased cells first.
“As soon as you move to diseases that affect the muscles, the
brain and the heart, you can’t remove the diseased tissue. You add your healthy
or cured cell to 95 that have not been cured. You can’t simply transplant the
cells and hope that it will work. This has been the lesson we have learned over
20 years,” he said.
Although it is dangerous to predict the future, he says there
are some important trials coming up that he thinks will work: two of them in
Parkinson’s disease. Parkinson’s is not like some other neurological diseases,
such as MS, because it is very localised. The other promising therapy on the
horizon is for the blood disorder thalassemia.
The commission says the research is important and must continue.
“To realise the potential of this diverse field and improve wellbeing for all,
it is clear that we must unite to address the ethical and governance issues,
while supporting multifaceted research that brings together scientists,
clinicians and engineers from academia and industry,” said another of the
authors, Prof David Price, vice-provost for research at University College
London.
https://www.theguardian.com/science/2017/oct/04/charlatans-threaten-stem-cell-research-with-unproven-cures-say-experts
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