H U M A N S T U D I E S
In 2019 a mono-center phase I safety study in chronic SCI patients (Spain) as well as a multi-center delayed-start phase II and phase II/III in (sub)acute SCI patients (Denmark and Spain) was submitted. In 2020 Neuroplast is going to double the number of clinical trial centers for the Phase II/III SCI study with a center in Germany and a center in The Netherlands. Due to the actual Covid-19 pandemic, these studies are planned to start in Q2 2020. The coordinating Principle Investigator is Prof. dr. Fin Biering-Sørensen, an international expert in the field of spinal cord injury diagnostics and rehabilitation. The phase I study is defined to not only explore safety aspects, but to also gather exploratory information about the effects of Neuro-Cells in chronic spinal cord injury patients, so to speak: a human proof of concept (POC).
Neuroplast is planning to start a company in the US to develop Neuro-Cells (FDA-approved) for the US market for the indication Spinal Cord Injury and later on also for the indication ALS.
In 2021, Neuroplast is going to submit a delayed-start multi-center phase II study in ALS
(Europe – United States).