Correspondence

Nature 453, 1177 (26 June 2008) | doi:10.1038/4531177c; Published online 25 June 2008

Stem-cell urological treatment was not carried out illegally

Hannes Strasser1

  1. Universitätsklinik für Urologie, Medizinische Universität Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria

Sir

I want to express my displeasure at the News story 'Doctors accused of doing illegal stem-cell trials' (Nature 453, 6–7; 2008).

A prospective cohort study and a prospective randomized trial of our procedure for treating urinary incontinence with autologous myoblasts and fibroblasts were filed with the ethics committee of the University of Innsbruck in February 2001. I cannot explain why these documents are no longer intact in the committee's records. Results of the prospective randomized trial, involving 63 women, were published last year (H. Strasser et al. The Lancet 369, 2179–2186; 2007).

The ethics committee itself emphasized that approval for the study should be applied for at the Arzneimittelbeirat (pharmaceutical committee) of the Austrian Ministry of Health, owing to the novelty of the projects. After receiving the protocols, the Arzneimittelbeirat had no objections to performing clinical studies in June 2002. Andreas Scheil's assertion that the last time approval for studies was given by the government, and not by an ethical committee, was during the Third Reich is insulting.

After our publication in The Lancet, the ethics committee asked the director of the Ministry of Health's office for public health, Hubert Hrabcik, to reinvestigate the application and approval for the trial published in The Lancet. In October 2007, Hrabcik informed the ethics committee that the Arzneimittelbeirat dealt with the trial published in The Lancet and confirmed that approval by the Arzneimittelbeirat represents ethical approval.

Because of results showing advantages compared with other therapies, and as production of the stem cells required for the treatment of urinary incontinence had been approved by the Ministry of Health, the department of urology decided to offer this therapy outside clinical trials to selected patients who had signed an informed consent. The patient mentioned in your article, Dieter Bollmann, had no postoperative side-effects or complications. I want to emphasize that, although your article states that "patients" are taking legal action, I only know of this single case of a patient suing the hospital.

On 8 May, TILAK (the company that manages the Innsbruck University hospital) and the department of urology of the Medical University of Innsbruck issued a joint statement in which they expressed regret for past misunderstandings, differences of opinion, problems in coordination of procedures, and irritations. A new, extensive clinical study will be performed in close coordination with the ethics committee in reaction to the new European Union directive on advanced therapies.

After the completion of successful clinical studies, it is planned to offer the injection of autologous myoblasts and fibroblasts as standard therapy in the future, to the benefit of the Tyrolean population.