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.