One of the big stem cell-related stories of 2013 was the controversy over the Stamina Foundation in Italy and its potential use of largely untested stem cell products on patients, including mostly children. The winner of my 2013 Stem Cell Person of the Year Award was Dr. Elena Cattaneo and one reason she won was the courage she had in standing up to Stamina.
Today’s post is Part 1 of at least 2 in a blog series on Stamina.
The Stamina controversy continues in 2014. You can see an image above (and another further down in the post) taken just yesterday in front of the Italian Parliament by pro-Stamina protestors.
Stamina and its leader David Vannoni, whom Nature describes as “a psychologist turned medical entrepreneur” have been embroiled in a complicated situation that has involved scientists, politicians, celebrities, and the aforementioned street protests.
The so-called “Stamina method” for supposedly making neural cells from mesenchymal stem cells is not supported by hard science so the fact that it is being used to treat patients including children is very dangerous.
Scientists in Italy and around the world have almost entirely been skeptical of Stamina or outright condemned it. For example, ISSCR issued a statement of concern including a quote from Nobel Laureate Shinya Yamanaka:
“We sympathize with patients with incurable diseases. However, there is little objective reason to believe that these patients have the possibility of benefitting from a mesenchymal stem cell therapy and treatment decisions should not be made outside of a controlled clinical trial without data on safety and efficacy.”
Nature has done a great job covering the story, including an excellent piece on Tuesday by Alison Abbot that includes both new developments based on leaked documents from Italy as the situation continues to boil over. What was in the leaked papers? Nature says:
The leaked papers reveal that the original expert committee identified serious flaws and omissions in Stamina’s clinical protocol. It did not apply legally required Good Manufacturing Practice standards, the committee says. The protocol exposed an apparent ignorance of stem-cell biology and relevant clinical expertise, the report argues, as well as flawed methods and therapeutic rationale…
One of the other notable aspects of this recent Nature piece is tying Stamina together with US researcher Camillo Ricordi and his Cure Alliance Foundation. In my stem cell predictions for 2014, #9 included the now proven correct prognostication that Stamina would be linked up to US players.
Nature indicates that Ricordi has been a public proponent of Stamina and reportedly has supported it strongly with political leaders in Italy. Since the piece published in Nature yesterday, Ricordi has said that his ties to Stamina are not so strong as some have suggested. He also took a shot at me in the comments section of the Nature piece for giving the Stem Cell Person of the Year Award to Cattaneo.
Vannoni has responded to the Nature piece too. For example, he did a post on his Facebook page claiming that Stamina works and included, which I believe is unconscionable, pictures of a pediatric patient to support his case:
“Warning – writes Vannoni – Stamina is not dangerous and useless (at best makes you fat .) Here is Joel’s first (3.8 kg and completely still , if you do a remnant of a hand) and Joel today ( 10.8 kg with movements of the arms , legs , neck, and hands ) . “
What a strange, dangerous situation.
Vannoni and Stamina have made many claims, and some seem to be unraveling according to Nature:
A week after the leaks, the health ministry revealed that the condition of 36 patients treated with Stamina’s stem-cell therapy had not improved, contrary to Vannoni’s claims that more patients had shown improvement.
I cannot fathom how Stamina could be good for the patients, including mostly vulnerable children.
Stay tuned for more blog posts in this series including new quotes from some of the scientists who have raised concerns and additional information.