Urethral occlusion after "cell therapy" with UROCELL: A 69-year-old patient has been suffering from incontinence since surgery for prostate cancer in 2004. In March 2006, after prior removal of muscle tissue from the upper arm and separate culturing of myoblasts and fibroblasts, he receives transurethral injections of the cell material ("UROCELL" therapy) at a clinic in Innsbruck. His incontinence improves only slightly thereafter; however, he developed increasing problems with emptying the bladder. 10 weeks after cell implantation there is a total occlusion of the urethra so that an indwelling catheter has to be placed. Cystoscopy revealed stenoses in the area of the cell implant, necessitating multiple surgeries, including among other things dilatation of the urethra. The placement of an artificial bladder sphincter is considered (NETZWERK report 14,990). Bladder rupture, which requires surgical treatment, occurs in a 70-year-old patient after implantation of cultured myoblasts. He also develops complete urethral occlusion 9 weeks later (15,025).

A procedure developed at an Innsbruck clinic which, according to the vendor (1,2), is also practiced in Germany, in which myoblasts and fibroblasts are obtained from a muscle biopsy, augmented in culture for 6 to 8 weeks, and then injected into the sphincter of the bladder, is claimed to lead to regeneration of the bladder sphincter. The myoblasts are infiltrated into the rhabdosphincter, the fibroblasts together with bovine collagen (CONTIGEN) into the urethral submucosa. The vendor claims that "no side effects of UROCELL cell therapy are known to date" (1), even though he must have knowledge of the adverse event reported in NETZWERK report 14,990. The "Patient information" (3) also does not elucidate that this is as yet only an inadequately studied experimental procedure. Over the past several weeks this has become a focus of public attention (4-6), because a patient is suing for damages because of ineffectiveness and concealment of the experimental nature of the therapy.

In addition, inconsistencies in a study (7) about this therapy published in the Lancet by the Innsbruck team came to light. Very good effectiveness is claimed for the procedure in the study with 63 women suffering from stress incontinence: 38 (90%) of 42 patients experienced complete remission of symptoms after one year as opposed to only 2 (10%) of 21 patients who were injected only with bovine collagen instead of with the cell substrate. According to members of the responsible ethics committee and a recent statement by the Austrian Health Minister (8), this study should not have been started because of a missing vote by the ethics committee. In addition, the study registration number cited in the publication is incorrect (9) and it is unclear whether the randomization process cited in the publication had been planned at the beginning of the study (10). The results from other clinics in which UROCELL was used are considerably worse (11, 12), which creates additional doubts about the validity of the results.

The culturing of the cells alone costs about € 9,000 (including VAT tax), which is not covered by the statutory health insurance fund. Two of the authors of the study that appeared in the Lancet are also co-owners of the company where the cells are cultured (7).

We classify the procedure as a purely experimental method that is by no means without side effects. It should be only conducted in the context of prospective, planned, randomized, controlled studies.