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Thirteen scientists declare their opinion about the Stamina "method" on EMBO Journal

Thirteen scientists committed to stem cell research have chosen the prestigious review EMBO Journal[it opens another window]  to provide a detailed and precise analysis of the Stamina "method," the presumed treatment based on mesenchymal stem cells administered in an Italian government hospital to patients presenting rare diseases, ranging from spinal muscular atrophy to vegetative coma. The treatment lacks the necessary premises of efficacy and safety, besides the rationale and preclinical tests required for human use.            

The paper - which has also been authored by three Italian researchers, namely Paolo Bianco at La Sapienza University, Rome, Elena Cattaneo, our professor at the Department of Biosciences and Director of Unistem Centre, and Michele De Luca at the University of Modena and Reggio Emilia - cites the law that was passed on 22 May 2013 by the Italian Parliament, which started limited clinical trials on the so-called  Stamina "method," coordinated by the Istituto Superiore di Sanità (Italian National Health Institute - ISS).

The "method" in question is proposed by the non-profit Stamina Foundation and envisages the conversion of mesenchymal stem cells, which normally generate bone, cartilage and adipose tissue, into neurones after brief exposure to ethanol and retinoic acid.            

As emphasised in the paper by the thirteen scientists, the "Stamina method" is not only inconsistent in terms of clinical trials and scientific and therapeutic rationale, but it also lacks publications that "describe" it and make it reproducible by others. Said methodological deficiencies have also been confirmed by the response to patent applications submitted by Stamina Foundation to the US Patent Office.            

The treatment proposed by the private, non-medical foundation had already been blocked by the Italian Medicines Agency (AIFA) in May 2012, leading patients to resort to occupational judges to restore its use.            

Reactions to the introduction of the Stamina "method" in an Italian Government hospital - which were aroused after the former Minister of Health Renato Balduzzi decided to authorise continuation of treatment - were led not only by the academic world but also by some associations of patients with diseases treated by said “method.”            

A first appeal [it opens another wndow] (Italian text) was made on 15 March 2013. Italian researchers, scientists, jurists and rectors of universities, including Gianluca Vago, Rector of the University of Milan, and Elena Cattaneo, stated their doubts about the former Minister Balduzzi's decision to authorise treatments to be continued because they were ineffective and lacked scientific and safety rationale.             

This first appeal was followed by a similar stand taken by the scientific review Nature published on 28 March [it opens another window]  and on 16 April [it opens another window]. Even the International Society for Stem Cell Research (ISSCR) intervened with a communication made by the Nobel Prize Winner Shynia Yamanaka [it opens another window] who even on 22 April 2013 [it opens another window] spoke strongly against any stem cell-based treatment proposed outside patient protection rules. Even the European Medicines Agency [it opens another window] (EMA) reminded that stem cell-based treatments, when effective, must be controlled by regulatory agencies, such as the Italian Medicines Agency (AIFA), which evaluate and certify compliance with the rules and characteristics of products to be administered to humans.            

Conversely, defining said treatments as "transplants" (as claimed by the proposed law that was originally approved for processing by the Senate) would have entailed, according to the EMA and all scientific and medical authorities that intervened, a reduction in controls and, therefore, lesser protection for patients. Particularly in the Italian framework, it might have made the "treatment" refundable, regardless of its actual efficacy.            

On 13 May even the Accademia dei Lincei [it opens another window] (Italian text) unanimously intervened regarding the case with a motion that was approved by acclamation stating that "a law with said characteristics would encourage practices that are rapidly spreading for solely commercial purposes."            

The stand taken by doctors and researchers at the University of Brescia  (Italian text), by several patient associations (Famiglie SMA, SMA Europe and AISLA), by neurologists and transplantologists, by international experts and by the Italian Stem Cell Society (SCR Italy) are equally important. They too are against the administration of preparations that have not been validated.            

The doubts stated by the scientific world have, therefore, been expressed by important amendments implemented to the law on the Stamina "method" during the vote at the Chamber of Deputies on 20 May 2013. Said amendments avoided the risk of indiscriminate use of mesenchymal stem cells in rare diseases, regardless of their efficacy and safety, and outside European and Italian laws.            

The law that was passed yesterday (22 May 2013, editor's note), instead, envisages limited clinical trials on the so-called "method" for a period of 18 months, allocating 3 million euro to said purpose.            

Professor Paolo Bianco, an author of the paper published on EMBO Journal, made the following statement to the Italian National Press Agency (ANSA): "The new law that was passed yesterday has avoided a disaster that would have wrecked the National Healthcare System by opening an extremely dangerous passage to Europe for piracy on the part of merchants of false stem cell-based therapies that rage in other countries, exposing thousands of people to serious risks and to even more serious speculation. Not everybody realises that we barely escaped disaster for both people and the State, and it was avoided at the last minute."            

However, the law leaves the door open to a challenged clinical trial on the "method" in question that must be conducted with cell preparations produced in compliance with European rules and, therefore, with GMP (Good Manufacturing Practices). This implies that the "method," the rationale, past results, cells and details of the procedure must be made available for transfer to certified facilities for production in compliance with GMP.            

Many scientists believe that said transfer of the clinical trial under the control of certified facilities might even reveal the non-existence of the "method" and, therefore, the impossibility to carry out any clinical trials in compliance with the rules.            

Considering the unanimous response of Italian parliamentarians against the false antithesis of scientific rigour and patient solidarity, the case of the Stamina "method" once again proves that Italian universities are continuously called to keep watch to ensure that knowledge and information - especially in such a sensitive framework such as biomedicine - are communicated and disseminated to society at large in a truthful and balanced way, based on documented scientific evidence.

14 June 2013
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