Subscribe to the BioNews newsletter for free

Login
Advanced Search

Search for
BioNews

Like the Progress Educational Trust on Facebook


 


 

Italian government orders trial of controversial stem cell therapy

03 June 2013

By Nishat Hyder

Appeared in BioNews 707

The Italian Senate has approved an 18-month, €3 million clinical trial of a controversial stem cell-based therapy. The vote, on 22 May 2013, will also allow a hospital to continue to treat patients already undergoing the contested treatment - although new patients may not be enrolled.

Developed by Davide Vannoni, a psychologist at the University of Udine and president of the Stamina Foundation in Turin, this therapy uses patients' own mesenchymal stem cells, derived from bone marrow, to treat neurodegenerative conditions such as Parkinson's, Alzheimer's, and amyotrophic lateral sclerosis, as well as muscle-wasting disorders. The Italian Medicines Agency (IMA) closed Vannoni's clinic in Brescia, where Stamina was treating up to twelve patients, in 2012 after a site visit.

Some of the patients receiving treatment and their families then sought legal exemption under compassionate use. Under Italian law, unapproved therapies are allowed on the grounds of compassion in exceptional cases for patients suffering from severe, incurable conditions only as a last resort. However, the therapy in question must meet Italian quality control standards, and there must be published data recognising its safety and efficacy.

As Professor Amedeo Santosuosso, a Milanese judge, and president of the European Centre for Law, Science and New Technologies, University of Pavia states: 'In the case of the Stamina Foundation therapy, there is no suggestion that it might be efficacious, so in my opinion compassionate use is not legitimate'.

Both within Italy and throughout the international community scientists have expressed serious concern over the efficacy of this treatment. The International Society for Stem Cell Research has issued a statement, saying: 'It is not clear based on the scientific literature that mesenchymal stem cells have any ability to ameliorate neurological conditions nor is there compelling evidence from clinical trials that such cells provide benefit to patients with neurological conditions'.

The final version of the law significantly amends the original decree, which was proposed in March amid protests from patient groups and pro-Stamina supporters after the treatment was halted by the IMA. The initial version, proposed by then-health minister Renato Balduzz, would have allowed thousands of patients to join the trail but was met with widespread disapproval from the scientific community. It would have also likely fallen outside the European Union's regulation of such therapies, says Science Insider.

Some see this episode as symptomatic of the lack of steady support for stem cell research in Italy. Massimo Dominici, a cell biologist at the University of Modena, claims that the clinical trial is '…a waste of money'. He states that 'if the Government would provide enough research funding, we could translate research into [therapies] under scientific rules, rather than this way'.

Vannoni has said the Stamina Foundation will not be able to provide the treatment according to good manufacturing practice. He explained the treatment is not able to be prepared according to international standards as the composition of the culture medium varies every two days.

SOURCES & REFERENCES
International Society for Stem Cell Research | 09 April 2013
 
ScienceInsider | 22 May 2013
 
AFP | 23 May 2013
 
Gazzetta del sud | 23 May 2013
 
Nature News Blog | 22 May 2013
 

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

21 November 2016 - by Rachel Siden 
Italian prosecutors are investigating whether discredited stem-cell entrepreneur Davide Vannoni is continuing to offer his unproven therapies in eastern Europe...
23 September 2013 - by Nishat Hyder 
An expert panel of scientists has issued a report advising the Italian Government against continuing to support a controversial stem cell therapy, deeming it 'unscientific'....
15 July 2013 - by Nishat Hyder 
Davide Vannoni, head of the Stamina Foundation in Turin, Italy, and pioneer of a controversial stem cell therapy, has once again hit the headlines amid allegations of poor research methodology...

18 February 2013 - by Reuben Harwood 
What would be the first clinical trial to use induced pluripotent stem cells has been granted ethical approval in Japan...
14 January 2013 - by Sarah Pritchard 
The US Supreme Court has declined to hear a final appeal seeking to challenge the legality of using public money to fund embryonic stem cell (hESC) research...
15 October 2012 - by Joseph Jebelli 
Scientists have successfully implanted human neural stem cells into the brains of children with a rare neurological disorder...
28 August 2012 - by Nishat Hyder 
Stem cells harvested from patients' own umbilical cord blood are to be trialled in the US as treatment for children with autism...

HAVE YOUR SAY
Be the first to have your say.

You need to or  to add comments.

By posting a comment you agree to abide by the BioNews terms and conditions


- click here to enquire about using this story.

Published by the Progress Educational Trust

CROSSING FRONTIERS

Public Conference
London
8 December 2017

Speakers include

Professor Azim Surani

Professor Magdalena Zernicka-Goetz

Professor Robin Lovell-Badge

Sally Cheshire

Professor Guido Pennings

Katherine Littler

Professor Allan Pacey

Dr Sue Avery

Professor Richard Anderson

Dr Elizabeth Garner

Dr Andy Greenfield

Dr Anna Smajdor

Dr Henry Malter

Vivienne Parry

Dr Helen O'Neill

Dr César Palacios-González

Philippa Taylor

Fiona Fox

Sarah Norcross

Sandy Starr


BOOK HERE

Good Fundraising Code

Become a Friend of PET HERE and give the Progress Educational Trust a regular donation