P R E C L I N I C A L S T U D Y
In 2017 Neuroplast completed its pre-clinical program for the indications Spinal Cord Injury and Amyotrophic Lateral Sclerosis. In these preclinical Proof-of-Concept studies, not any sign of toxicity and/or other safety issues could be found.
In 2017 no signs of toxicity or tumorgeneticy could be established in an extensive preclinical research protocol (CERB, France) with intrathecal applied Neuro-Cells®.
Safety and efficacy of Neuro-Cells® could be established in T-cell deficient rats with balloon compressed induced Spinal Cord Injury. Confirmation of the results and superiority compared to a high dose of methylprednisolone could be established in otherwise healthy rats with a weight-induced Spinal Cord Injury.
Safety and efficacy (superior to an intervention with riluzole and/or celecoxib) of Neuro-Cells® could be established in both the SOD-1 transgenic Amytrophic Lateral Sclerosis (ALS)-like mice as well as the FUS (1-359)-transgenic ALS-like and frontotemporal lobular degeneration (FTLD)-like mice.
Based on the preclinical results, EMA decided to grant Neuro-Cells® an Orphan Designation (OD) for the indication (sub)acute SCI. In the meantime, Neuroplast also applied an OD for the indication ALS.
In collaboration with: University of Tampere, Trium Clinical Consulting, Université Lille Nord de France, Universiteit Hasselt, Universität Würzburg, Maastricht UMC+, University of Oxford.