Ethical lapses and procedural breakdowns plagued an Austrian clinical trial of a stem cell therapy that used patients' own cells to treat urinary incontinence, according to a report recently released by the country's Agency for Health and Food Safety (AGES).

The AGES report says that urologists involved in the study engaged in a series of questionable activities: They designed the trial poorly, inadequately randomized patients, conducted the trial without the appropriate ethics approval, and failed to properly inform trial participants about the nature of the study.

The study was published last year in The Lancet.

Hannes Strasser, a Medical University of Innsbruck, Austria, urologist and the study's lead author, is mentioned throughout the AGES report. According to Nature, Medical University of Innsbruck administrators have barred Strasser from seeing patients in the university's hospital. Strasser has denied any wrongdoing in a letter to the university.

The stem cell treatment involved harvesting muscle cells from 42 female patients' arms, using those samples to develop autologous myoblasts and fibroblasts, then implanting the stem cells into patients' urinary sphincters.

Several of the patients treated by Strasser and his colleagues, both as part of the trial and outside the study, have reported severe side effects, including sealing of the urinary sphincter and ruptured bladders, according to Nature.

Suspicion of the study was initially raised by the university's rector, Clemen Sorg, who told university researchers of his concerns in November of last year.

The AGES report absolves Strasser's co-author and head of the urology department, Georg Bartsch, from any blame in the case. Bartsch told Nature that he was included as an author on the paper "in honor of my seniority." However, Bartsch headed a university committee that initiated the installment of guidelines for "good scientific practice" by faculty, and signed off on many of the documents relating to the controversial stem cell therapy.

University officials have asked that Strasser retract The Lancet paper and another related paper by August 18.

The Austrian Academy of Sciences has suspended its investigation of the alleged misconduct while university officials decide on further disciplinary actions against Strasser and Bartsch.