ICES13 - Clinical Trial Program

More than 500 patients suffering from stress urinary incontinence (SUI) have been treated using Innovacell’s cell-based therapy since 2002. Today Innovacell possesses the largest population of patients, patient data and experience in the treatment of SUI using cell therapy. This wealth of knowledge was successfully deployed in the design and approval of a multi-centre Phase IIb clinical trial for ICES13 as well as in the follow up multi-centre Phase III clinical trial for ICES13.

Innovacell is with the completion of the Phase IIb clinical trial the first company world-wide to develop autologous, individualized cell therapy for the treatment of incontinence as a fully clinical tested and approved product by a regulatory agency (EMA). The Phase IIb clinical trial has been conducted in 32 European countries, the interim results are available since end of Q1/2011 and the final results since July 2011. Middle of 2011, Innovacell will start the Phase III clinical trial, first results will be available in Q3/2012. Marketing authorization in the EU is expected to be available in 2013.