Nature

Doctors accused of doing illegal stem-cell trials

Patients in Austria may have been misled.

Alison Abbott

Patients treated outside of clinical trials in the Urology Department (inset) of the Medical University of Innsbruck may not have been insured.Clinical trials led by Hannes Strasser have come under scrutiny by an Austrian ethics committee.MEDICAL UNIV. INNSBRUCK

An apparently successful stem-cell treatment for urinary incontinence is now being questioned after it has emerged that clinical trials for the therapy may have been done illegally.

Patients who received the stem-cell procedure in operations at a hospital in Innsbruck, Austria, are now taking legal action against the hospital's management, in a scandal that goes right to the heart of the country's health ministry.

Next week, a civil court will hear the case of 70-year-old Dieter Bollmann from Berlin, who paid more than €11,000 (US$17,000) for the procedure in 2005. He claims that urologists, led by Hannes Strasser, at the University Hospital Innsbruck told him that the treatment had a very high success rate, and implied that clinical trials had been completed. The consent form that Bollman signed, and which Nature has seen, does not include the word 'experimental'. The operation did not improve his symptoms.

Bollmann is suing TILAK, the administrative body that runs the university hospital, for €4,000 damages, in a suit he originally filed in 2006. Around that time, TILAK told Strasser and his team not to do any further operations outside of a formal clinical trial. A TILAK spokesman has told local newspapers that the team carried out a further 60 or so. In all, hundreds of patients have been treated outside of clinical trials, it is alleged. A preliminary investigation by Austria's ministry of health has found that such patients are not insured for experimental procedures.

And the issue goes deeper. The independent ethics committee that approves and oversees clinical trials at the university and hospital is now concerned that the clinical trial of the procedure's efficacy, carried out by Strasser's team and published in The Lancet last June, may have been illegal. The Ministry of Health is now investigating claims by the ethics committee that it was never contacted, as law requires, about the trial on 63 women who were recruited between 2002 and 2004 (H. Strasser et al. Lancet 369, 2179вЂ"2186; 2007). And some members of the committee claim that documents may have been created to cover up omissions. Further probing reveals apparent irregularities that trace back to the ministry itself.

“It is important to repeat the good results in independent sites.”

Strasser's involvement with the ethics committee began in 2001, when he applied to conduct phase I pilot studies on his technique, to establish its safety. His procedure involves culturing muscle stem cells and fibroblasts from a small sample of tissue taken from a patient's arm. The cultured cells, produced by Innovacell Biotechnology, a company co-founded and co-owned by Strasser, are then injected into the same patient's urinary sphincter, the muscle at the base of the bladder that controls urine flow, where the cells are intended to promote new muscle growth and so increase the power of the sphincter.

The committee initially denied approval because the submission lacked data on, for example, animal experiments, which are necessary before new medical interventions can be used in humans. A year later the scientists provided these data and obtained approval from the Ministry of Health's technical committee. The university ethics committee then approved two phase I studies, in 2002 and 2003, in a total of 25 patients. Eventually, just 21 were recruited.

It was not until March 2007 that the urologists applied formally to undertake a phase II clinical trial вЂ" to assess the efficacy of their technique вЂ" on 100 patients. They included the draft of their Lancet paper in the supporting data they provided to the ethics committee. This was how the committee learnt that a randomized, controlled trial of 63 women had already been conducted without its approval.

The trial published in The Lancet states that it is registered on controlled-trials.com, however the reference number provided leads not to a national trial database but to an approval for the production of therapeutic cells by Innovacell.

Clinical trials led by Hannes Strasser have come under scrutiny by an Austrian ethics committee.Patients treated outside of clinical trials in the Urology Department (inset) of the Medical University of Innsbruck may not have been insured.MEDICAL UNIV. INNSBRUCK

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