Researchers have confirmed that transplanting autologous muscle-derived cells (AMDC) into the bladder is safe at a wide range of doses and significantly improves symptoms and quality of life in patients with stress urinary incontinence.
The study was presented at the 104th Annual Scientific Meeting of the American Urological Association (AUA) and showed that the injection of muscle-derived cells was well tolerated and significantly improved symptoms.
Researchers conducted two study phases on the efficacy and safety of muscle-derived cell transplantation. In the study phases, which are ongoing, 29 women (mean age of 49.5), whose stress urinary incontinence symptoms had not improved within a year of standard therapy, received cystoscope-assisted periurethral cell injections. At the three month follow-up appointment, participants could elect a second injection of the same dose. Follow-up occurred at one, three, six and 12 months after the last injection. Clinical outcomes were evaluated with a pad weight test, a voiding diary and validated quality of life questionnaires. In the first, double-blind phase, 20 patients were randomized into five groups to receive one, two, four, eight or 16 x 106 AMDCs. In the second, single-blind phase, nine patients were randomized into three groups to receive 32, 64, or 128 x 106 AMDCs.