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Italian scientific panel advises against government-funded stem cell trials

23 September 2013
Appeared in BioNews 723

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'. 

Earlier this year, the Italian Senate approved an 18-month, €3 million clinical trials of the therapy (reported in BioNews 707). Amid widespread concern in the international scientific community as to the efficacy and safety of the therapy, a scientific advisory committee, appointed by the Italian Health Minister, Beatrice Lorenzin, was tasked with evaluating the clinical protocols submitted by the Stamina Foundation, the company that developed the therapy.

The protocols purport to outline the scientific methodology behind the therapy, which involves using 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.

According to ScienceInsider, the panel found the submitted protocols incomplete - records of preclinical studies had not been included. Furthermore, an absence of data on the quality of cellular preparation, and an inability to demonstrate the expected expression of proteins in stem cells as they form new neurons, led the panel to return a negative verdict.

Stamina's mesenchymal stem-cell therapy has been the subject of much controversy. In July this year an investigation by Nature revealed that Stamina's (failed) US patent application was based on unsound data (reported in BioNews 713). ScienceInsider adds that a fraud investigation into the alleged selling of unapproved therapies from 2012 is ongoing.

Despite this, there is still support for this therapy from some quarters. Pierpaolo Vargiu and Eugenia Roccella, the president and vice-president of the social affairs committee of the Lower House respectively, are both on record saying that Stamina's work is too important to abandon.

Meanwhile, the Italian Government is faced with a tough decision: whether or not to continue with the clinical trial, amid pressure from patient groups demanding the option of 'last hope' treatment on the one hand, and scientists advising against an ineffective and potentially dangerous treatment on the other.

Stamina's president, Davide Vannoni, told ScienceInsider that at that time he had not heard about the panel's findings but he was surprised it had not asked to see the medical records of the patients treated in Brescia, where the company has a clinic, and which he had presented in a challenge against the appointment of the panel. 

Advisers declare Italian stem-cell therapy ‘unscientific’
Nature News Blog |  12 September 2013
No Point in Testing Controversial Stem Cell Treatment, Italian Panel Says
ScienceInsider |  12 September 2013
Stem cell research triggers new controversy
Gazzetta del sud |  12 September 2013
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...
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...
3 June 2013 - by Nishat Hyder 
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...
7 January 2013 - by Dr Linda Wijlaars 
Bone fragments were removed from the eyelid of a woman after a facelift that used her own stem cells yielded some unexpected results...
6 February 2012 - by Dr Maria Botcharova 
A clinic in California has announced that its doctors are licensed and trained to carry out a stem cell treatment for chronic pain. Meanwhile, the US Food and Drug Administration (FDA) is pursuing a lawsuit against Regenerative Sciences, the company that developed the technique...
23 August 2010 - by Nishat Hyder 
The US Food and Drug Administration (FDA) has demanded a federal injunction from the US District Court of the District of Columbia to stop Regenerative Sciences (a Colorado based stem cell clinic) from using patients' own stem cells as medicinal treatment...
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