A number of patients have received treatment with a precursor product of ICES13 since 2002. Thus Innovacell possesses many years of experience in the production of cell therapies and the treatment of patients. This wealth of knowledge was successfully employed in the design and approval process for the multi-centre Phase IIb clinical trial, as well as in the subsequent multi-centre Phase III study.
With the end of the Phase IIb clinical trial for ICES13, Innovacell became the first cell-therapy enterprise anywhere in the world to have reached this advanced development stage. The conclusions of the Phase-IIb study have been available since July 2011.
In the middle of 2011, Innovacell began work on the Phase III clinical trial, which has delivered some groundbreaking findings. Further results are expected by the middle of 2014. In parallel, a pharmaco-dynamic study is being carried out in Slovenia. It is planned to obtain an EU permit in 2015. Results will be available by the end of 2015.