Preclinical studies of the last years have paved the way for the use of adult muscle derived stem cells for reconstruction of the lower urinary tract. In a first clinical study, incontinent patients were treated with ultrasound (US) guided injections of autologous myoblasts and fibroblasts.

Between September and December 2002, five female patients suffering from urinary stress incontinence (age: 36-78 years) were included in the study. Skeletal muscle biopsies were taken from the left arm to obtain cultures from autologous myoblasts and fibroblasts. A defined incontinence score, urodynamic, electromyographic and laboratory parameters, quality of life as well as morphology and function of urethra and rhabdosphincter were evaluated before and up to one year after therapy. Transurethral and three-dimensional US were used to investigate the lower urinary tract. The fibroblasts were mixed with collagen as carrier for the cells and injected into the urethral submucosa to treat atrophies of the mucosa, while the myoblasts were directly injected into the striated urethral sphincter, the rhabdosphincter, to reconstruct the muscle.

In all 5 patients urinary incontinence was cured one year after injection of autologous stem cells. Quality of life was significantly improved postoperatively (p<0.001). Transurethral US showed a significantly increased thickness of urethra (3.6 mm vs. 5.2 mm; p<0.001) and rhabdosphincter (1.8 mm vs. 3.9 mm; p<0.001) as well as an improved contractility of the rhabdosphincter after therapy.

Our first clinical results demonstrate that urinary incontinence can be treated effectively with autologous stem cells. The present data support the conclusion that this therapeutic concept represents a revolutionary and very promising treatment modality to treat urinary incontinence.

F.F.,H.S.,R.M.: Hannes Strasser and Rainer Marksteiner are co-owner of the company (InnovaCell) which produces the stem cells.
Ferdinand Frauscher is consultant of the company.