In an open, prospective, single-center study, Cornu et al (2011) evaluated the safety of intra-sphincteric injections of autologous muscular cells in patients with post-prostatectomy incontinence (PPI; n = 12). Patients underwent intra-sphincteric injections of autologous muscular cells isolated from a biopsy of deltoid muscle. The primary endpoint was the Q(max) variation at the 3-month visit in order to assess potential bladder outlet obstruction. Secondary endpoints assessed side effects and efficacy parameters based on symptoms, quality of life score, voiding diary, pad-test, and urethral pressure profile at 1, 2, 3, 6 and 12 months after injection. No immediate complication occurred and no significant variation was noted on Q(max). The only side effects possibly product-related were 3 cases of urinary tract infection treated by antibiotics. An acceptable safety and tolerability of the procedure whatever the injected dose of muscular cells was demonstrated. Results on efficacy after 1 year were heterogeneous, with 4/12 patients describing reduced urine leakage episodes, 1/12 patient presenting increased maximal closure pressure, and 8/12 patients showing improvement on pad-test. The authors concluded that cell therapy consisting of intra-sphincteric injections of autologous muscular cells in patients with PPI was a feasible and safe procedure. They stated that these findings pointed out that some subjects may positively respond to this procedure, but clinical efficacy remains to be confirmed.