PET PET
  • My Account
  • Subscribe
Become a Friend Donate
  • About Us
    • People
    • Press Office
    • Our History
  • Get Involved
    • Become a Friend of PET
    • Volunteer
    • Campaigns
    • Writing Scheme
    • Partnership and Sponsorship
    • Advertise with Us
  • Donate
    • Become a Friend of PET
  • BioNews
    • News
    • Comment
    • Reviews
    • Elsewhere
    • Topics
    • Glossary
    • Newsletters
  • Events
    • Upcoming Events
    • Previous Events
  • Engagement
    • Policy and Projects
      • Resources
    • Education
  • Jobs & Opportunities
  • Contact Us
  • About Us
    • People
    • Press Office
    • Our History
  • Get Involved
    • Become a Friend of PET
    • Volunteer
    • Campaigns
    • Writing Scheme
    • Partnership and Sponsorship
    • Advertise with Us
  • Donate
    • Become a Friend of PET
  • BioNews
    • News
    • Comment
    • Reviews
    • Elsewhere
    • Topics
    • Glossary
    • Newsletters
  • Events
    • Upcoming Events
    • Previous Events
  • Engagement
    • Policy and Projects
      • Resources
    • Education
  • Jobs & Opportunities
  • Contact Us
  • My Account
  • Subscribe
  • Privacy Statement
  • Advertising Policy
  • Thanks and Acknowledgements
PETBioNewsNewsItalian government orders trial of controversial stem cell therapy

BioNews

Italian government orders trial of controversial stem cell therapy

Published 24 May 2013 posted in News and appears in BioNews 707

Author

Nishat Hyder

Image by Bill Sanderson via the Wellcome Collection, © Wellcome Trust Ltd 1990. Depicts Laocoön and his family (from Greek and Roman mythology) entwined in coils of DNA.
Image by Bill Sanderson via the Wellcome Collection, © Wellcome Trust Ltd 1990. Depicts Laocoön and his family entwined in coils of DNA (based on the figure of Laocoön from Greek and Roman mythology).

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 twelve patients already undergoing the contested treatment...

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.

Related Articles

Image by Bill Sanderson via the Wellcome Collection, © Wellcome Trust Ltd 1990. Depicts Laocoön and his family (from Greek and Roman mythology) entwined in coils of DNA.
Image by Bill Sanderson via the Wellcome Collection, © Wellcome Trust Ltd 1990. Depicts Laocoön and his family entwined in coils of DNA (based on the figure of Laocoön from Greek and Roman mythology).
News
9 January 2017 • 2 minutes read

Disgraced stem cell entrepreneur may be offering therapies abroad

by Rachel Siden

Italian prosecutors are investigating whether discredited stem-cell entrepreneur Davide Vannoni is continuing to offer his unproven therapies in eastern Europe...

Image by Bill Sanderson via the Wellcome Collection, © Wellcome Trust Ltd 1990. Depicts Laocoön and his family (from Greek and Roman mythology) entwined in coils of DNA.
Image by Bill Sanderson via the Wellcome Collection, © Wellcome Trust Ltd 1990. Depicts Laocoön and his family entwined in coils of DNA (based on the figure of Laocoön from Greek and Roman mythology).
News
13 September 2013 • 2 minutes read

Italian scientific panel advises against government-funded stem cell trials

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'....

Image by Sílvia Ferreira, Cristina Lopo and Eileen Gentleman via the Wellcome Collection. Depicts a single human stem cell embedded within a porous hydrogel matrix (false colour).
CC BY 4.0
Image by Sílvia Ferreira, Cristina Lopo and Eileen Gentleman via the Wellcome Collection. Depicts a single human stem cell embedded within a porous hydrogel matrix (false-coloured cryogenic scanning electron micrograph).
News
5 July 2013 • 3 minutes read

Investigation casts doubt on controversial Italian stem cell treatments

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...

Image by Sílvia Ferreira, Cristina Lopo and Eileen Gentleman via the Wellcome Collection. Depicts a single human stem cell embedded within a porous hydrogel matrix (false colour).
CC BY 4.0
Image by Sílvia Ferreira, Cristina Lopo and Eileen Gentleman via the Wellcome Collection. Depicts a single human stem cell embedded within a porous hydrogel matrix (false-coloured cryogenic scanning electron micrograph).
News
21 March 2013 • 2 minutes read

Stem cell therapy for autism gets clinical trial go-ahead

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...

Image by Sílvia Ferreira, Cristina Lopo and Eileen Gentleman via the Wellcome Collection. Depicts a single human stem cell embedded within a porous hydrogel matrix (false colour).
CC BY 4.0
Image by Sílvia Ferreira, Cristina Lopo and Eileen Gentleman via the Wellcome Collection. Depicts a single human stem cell embedded within a porous hydrogel matrix (false-coloured cryogenic scanning electron micrograph).
News
15 February 2013 • 2 minutes read

Japanese pluripotent stem cell trial receives ethical approval

by Rueben Harwood

What would be the first clinical trial to use induced pluripotent stem cells has been granted ethical approval in Japan...

Image by Bill Sanderson via the Wellcome Collection, © Wellcome Trust Ltd 1990. Depicts Laocoön and his family (from Greek and Roman mythology) entwined in coils of DNA.
Image by Bill Sanderson via the Wellcome Collection, © Wellcome Trust Ltd 1990. Depicts Laocoön and his family entwined in coils of DNA (based on the figure of Laocoön from Greek and Roman mythology).
News
11 January 2013 • 2 minutes read

US Supreme Court: Challenge to expand stem cell funding rejected

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...

Image by Sílvia Ferreira, Cristina Lopo and Eileen Gentleman via the Wellcome Collection. Depicts a single human stem cell embedded within a porous hydrogel matrix (false colour).
CC BY 4.0
Image by Sílvia Ferreira, Cristina Lopo and Eileen Gentleman via the Wellcome Collection. Depicts a single human stem cell embedded within a porous hydrogel matrix (false-coloured cryogenic scanning electron micrograph).
News
12 October 2012 • 2 minutes read

Stem cells safely transplanted into brains of patients with rare neurological disease

by Joe Jebelli

Scientists have successfully implanted human neural stem cells into the brains of children with a rare neurological disorder...

Leave a Reply Cancel reply

You must be logged in to post a comment.

« Human embryonic stem cell study under investigation

Data-Label The UK's Leading Supplier Of Medical Labels & Asset Labels

RetiringDentist.co.uk The UK's Leading M&A Company.

Find out how you can advertise here
easyfundraising
amazon

This month in BioNews

  • Popular
  • Recent
8 August 2022 • 2 minutes read

Placenta and organ formation observed in mouse embryo models

8 August 2022 • 2 minutes read

Lower hormone doses may improve IVF egg quality

8 August 2022 • 2 minutes read

Boosting muscle cell production of gene therapy proteins

1 August 2022 • 2 minutes read

First UK medical guidelines issued for trans fertility preservation

1 August 2022 • 2 minutes read

Male age has more impact on IVF birth rate than previously thought

8 August 2022 • 2 minutes read

Placenta and organ formation observed in mouse embryo models

8 August 2022 • 2 minutes read

Complex structures of the human heart bioengineered

8 August 2022 • 1 minute read

Brain tumour gene also linked to childhood cancers

8 August 2022 • 2 minutes read

Lower hormone doses may improve IVF egg quality

8 August 2022 • 2 minutes read

Boosting muscle cell production of gene therapy proteins

Subscribe to BioNews and other PET updates for free.

Subscribe
  • Twitter
  • Facebook
  • Instagram
  • LinkedIn
  • YouTube
  • RSS
Wellcome
Website redevelopment supported by Wellcome.

Website by Impact Media Impact Media

  • Privacy Statement
  • Advertising Policy
  • Thanks and Acknowledgements

© 1992 - 2022 Progress Educational Trust. All rights reserved.

Limited company registered in England and Wales no 07405980 • Registered charity no 1139856

Subscribe to BioNews and other PET updates for free.

Subscribe
PET PET

PET is an independent charity that improves choices for people affected by infertility and genetic conditions.

  • Twitter
  • Facebook
  • Instagram
  • LinkedIn
  • YouTube
  • RSS
Wellcome
Website redevelopment supported by Wellcome.

Navigation

  • About Us
  • Get Involved
  • Donate
  • BioNews
  • Events
  • Engagement
  • Jobs & Opportunities
  • Contact Us

BioNews

  • News
  • Comment
  • Reviews
  • Elsewhere
  • Topics
  • Glossary
  • Newsletters

Other

  • My Account
  • Subscribe

Website by Impact Media Impact Media

  • Privacy Statement
  • Advertising Policy
  • Thanks and Acknowledgements

© 1992 - 2022 Progress Educational Trust. All rights reserved.

Limited company registered in England and Wales no 07405980 • Registered charity no 1139856