Hans de Munter is working the last 16 years, as a pioneer to enable marketing registration for an autologous stem cell product to treat chronic and acute Neurodegenerative disorders. As an emergency physician and epidemiologist capable of translating stem cell research into a treatment model for patients. In these 16 years, he experienced the regulatory difficulties in dealing with a product, which consisted of patients own cells, was not manipulated, was not expanded but was seen as a tumour inducing and toxic substance, which has to be tested comprehensively in animals. He developed three multi-center placebo controlled randomized clinical trials with an autologous stem cell product, which were all approved (France 2009 and Czech Republic 2011 and Spain/Denmark 2019/2022) and one approved mono-center Phase I trial (Spain 2020). He defended his PhD thesis in april 2021 at the University Maastricht as part of the Department of Neuroscience and mental Health. Today, he is working as CEO in a scale-up company Neuroplast focussing to bring a not substantial manipulated autologous stem cell product to the market and is responsible for all the research, clinical development and general affairs. As a consequence of being a pioneer, he has published 10 peer-reviewed articles dealing with autologous stem cells, is co-author of another 5 scientific publications and is the inventor of 3 patents regarding ATMP processing. In his thesis he summarized the concept of reversed engineering and started with an idea, established preclinical evidence and ended in a clinical setup, which is still ongoing.

 

Abstract
The first clinical results of a comprehensive journey of reversed engineering ; bringing an living medicine to the patient.

In this presentation, the author will summarizes the preclinical research performed with a human GMP grade manufactured stem cell product Neuro-Cells. Give some insight in this product and highlight the adaptive approach with this naïve and fresh stem cell product to treat humans with the neurodegenerative disease Spinal cord Injury. In this presentation, he will present the clinical trial designs and the first clinical data of these trials (Phase I and the Phase II). Finally, he will end with some statements, which will showcase the challenges of working with a new medicine concept in a strong regulated medical world.