September 2016, Neuroplast BV successfully established a proof of concept study confirming the efficacy and the safety of Neuro-Cells in a double blind randomized study in T-cell deficient rats with a balloon compression-induced lesion of the spinal cord (Vanicky model).
Neuro-Cells did significantly (p<0.05) improve both locomotor functions and survival in those spinal cord-lesioned rats treated with Neuro-Cells as compared to rats treated with a placebo. Besides proof of concept, regulatory safety studies are planned to be performed in order to exclude eventual Neuro-Cells-induced malignancies and/or harm to vital organs (so-called tumorigenicity and toxicity studies), as without those studies, ethical committees and/or competent authorities will not approve human clinical trials. Execution of these studies, which are planned for January 2017, will take about 6 months.
In close collaboration with the European Medicines Agency, after the proof-of-concept study as well as the safety studies, a clinical study will be developed. For this part Neuroplast BV is interested in academic hospitals and/or spinal cord injury center hospitals with clinical trial experience capable of performing this kind of studies in a solid scientific way.