Paper on controversial stem cell “stamina therapy” retracted

A Korean stem cell journal has retracted a paper on a controversial Italian treatment that involves harvesting stem cells from bone marrow and injecting them back into the patient.

Stamina therapy” has been pitched as a treatment for everything from Parkinson’s disease to coma, based on a U.S. patent application filed in 2010. The Italian government pledged about $3.9 million in 2013 to support a clinical trial for stamina therapy. More than 100 people signed up for the trials, with a wide range of neurological ailments; half were children.

However, allegations of fraud led to a criminal investigation into the Stamina Foundation’s leader, psychologist David Vannoni, as well as 17 other members of the organization.

Stamina therapy proponents claim that stem cells from bone marrow can be manipulated to turn into nerve cells and heal dozens of neurological diseases, but there’s little peer reviewed evidence that supports this. Vannoni’s only publication on the therapy was the patent application, which provided few details and was rejected by the U.S. Patent Office.

Stem cell researcher Olena Shchegelska later determined that figures used in the patent application were lifted from a 2006 publication of hers, without attribution.

In November of this year the government stopped the clinical trials from moving forward. From Wired’s Italian site, via Google Translate:

In particular, the Scientific Committee has unanimously rejected the method, also stating that “it is not appropriate because the cells produced […] do not meet the requirements necessary to define them as ‘therapeutic’ , that the protocols do not meet the basic requirements for a clinical trial, the protocol and the method Stamina does not have the necessary requirements to perform a clinical trial, including the assessment of safety and efficacy and therefore the conditions for the start of a trial with the aforementioned method, with particular reference to the safety of the patient.”

The Korean stem cell journal, the International Journal of Stem Cells, published the paper, “Stem Cells and Niemann Pick Disease,” in May 2014, a year after the Italian government first began questioning the treatment. It was retracted on November 7, with a notice that gave absolutely no details about what led up to the withdrawal.

The notice simply says:

This article has been retracted at the authors’ request.

One of the primary concerns with stamina therapy is the lack of peer-reviewed data supporting its use, so the retraction of this paper, by Stamina Foundation vice president Marino Andolina, who was also investigated for fraud involving the treatment, is hardly surprising.

The paper has only been cited once, according to Thomson Scientific’s Web of Knowledge, by a letter to the editor Comment in Nature by two authors who have been critical of the therapy about a correction to a news story about the therapy in Nature.

We’ve reached out to both the journal and to Andolina, and will update if we find out what happened.

7 thoughts on “Paper on controversial stem cell “stamina therapy” retracted”

  1. maybe because the only author of the paper, Andolina M., is the vice-president of Stamina foundation…so there is a big conflict of interest not declared?? anyway if you read the paper there are no figures, only data reported, no functional test, only subjective observation. Luckily the italian government has decided to interrupt the clinical trials

  2. I am not surprised that Andolina’s claims didn’t stand scrutiny (and I doubt that the retraction was really upon the “author’s request”).
    On the other hand I was puzzled to read that the outstanding scientists who wrote the Nature letter to the editor – who have always been among the most determined opponents of Andolina, Vannoni & Co – could have cited that controversial paper. At first I supposed it could only be a very critical citation, but I checked and I don’t find any citation, neither in the letter(s) nor in the Nature News partly corrected article (which is not the one you linked. http://www.nature.com/news/row-over-controversial-stem-cell-procedure-flares-up-again-1.14613).
    So the citation recorded in the Web of Knowledge looks like a mistery to me.

      1. Ah, makes more sense now, thanks. I had the wrong citing paper. Fixed in the text, with strikethroughs. Thanks.

    1. Today my colleague Alice Pace (https://twitter.com/helixpis) – who has been covering the Stamina affair for a long time – wrote on Wired Italy that she spoke with Dr Marino Andolina, who confirmed to her that

      «If I had not retracted spontaneously the article, they would have done it. I didn’t have much choice».

      http://www.wired.it/scienza/medicina/2014/12/17/andolina-stamina-italia/

      There were basically two reasons: Andolina blames the journal for not complying to his request to correct an error some editor did (microliters were reported as milliliters), which in his reconstruction caused «strong animosity» between him and the journal.

      According to a note published online in the website of the Italian drug regulatory agency AIFA (http://www.agenziafarmaco.gov.it/it/content/il-presunto-metodo-stamina-retracted ) the journal also received several notes from AIFA stating that the experimental procedure described in the study was never authorised and that the report was riddled with inaccuracies and «mystifications».

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