José Manuel Baena, MSc is a Research Associate. He is the Founder of BRECA Health Care, pioneer in 3D printed custom made implants for orthopedic surgery, and REGEMAT 3D, the first Spanish bioprinting company. He is an expert in innovation, business development and internationalization. He is a Lecturer in some business schools, and is passionate about Biomedicine and Technology. In his free time, he also works as a Researcher at the Biopathology and Regenerative Medicine Institute (IBIMER).
Statement of the Problem: Regenerative medicine refers to methods to regenerate or replace human cells, tissues or organs in order to restore or establish normal function. The clinical use of stem cells, genes and tissues constitutes a new range of advanced therapy medicinal products (ATMPs) such as gene therapy medicinal products, somatic cell therapy medicinal products, tissue engineered products and combined advanced therapies’ products. Each of them can be formulated with different types of biomaterials to provide greater cell viability, such as release systems, scaffolds, etc. The purpose of this study is to describe the different products with stem cells and scaffolds that should be considered ATMPs for clinical application, to classify the different types of medicinal products and meet the legal requirements for their marketing authorisation. Methodology & Theoretical Orientation: The aim of this study was to define the main biomaterials used in ATMPs and medical devices, and the regulatory aspects for their clinical application. Thus, we searched the main available databases up to September 2016. Findings: Major advances in advanced therapies focus on the development of matrices made of natural or synthetic origin biomaterials such as collagen, alginate, hyaluronic acid, polyethylene glycol, etc. All of them should be considered medical devices by themselves, but if each scaffold is combined with stem cells, tissues or genes, they will be considered medicinal products. Conclusion & Significance: The ability to combine cells, tissues and genes with biomaterial manufactured structures to develop medicinal products, opens up new prospects in the administration of these ATMPs in the area of regenerative medicine.
Marco Consumi is a Research Scientist at Department of Biotechnology, Chemistry and Pharmacy in University of Siena, Italy. He has received his PhD in Biomaterials from University of Trento and studied polymers and polymer based materials for controlled release of active substances in pharmaceutical and nutraceutical field. As a Postdoctoral Fellow, he was focused on understanding the correlation between the chemical composition of materials and their biological activity. He has broad expertise in synthesis modification and characterization of polymers (naturals and synthetics) and materials for biomedical applications. Actually, he is involved in 2 EU ITN projects in bacterial infection topic to fundamentally better understand the biology, chemistry and physical properties of biofilms and 2 Toscany Region funded projects on nutraceutical filed.
Monascus fermented red rice (RYR) has been demonstrated to lower cholesterol in blood and sold over-the-counter as an alternative to cholesterol-lowering statin drugs, especially for who stopped statin drugs due to their side effects. The goal of this work is to develop an extended-release formulation, able to maintain the activity effect against the cholesterol, obtaining a constant release of statins present in RYR throughout the staying of the tablets inside the intestine. This study focus on the analysis of different carriers for controlled release systems composed by polysaccharide-based matrices by two different formulations based on K-Carrageenan and Gellan gum (ranging from 10-90% in weight). Samples as cylindrical tablets have been physicochemical characterized by FTIR, DSC, TGA, Rheometer and TOF-SIMS, water uptake, water bond, water diffusion and mesoporosity. The Monacolin K release has been monitored until 48 hours in simulated intestinal fluid SIF. HMG-CoA reductase activity has been measured to determine the formulation influence on statin activities against the Lovastatin activity used as control. The selected formulation enhances the statins release respect to the RYR matrix alone and in addition, the preliminary biological results suggest that the activity of these samples is associated with the inhibition of HMG-CoA reductase. Release tests pointed out that formulations obtained combining polymers in a ratio close to 1 (i.e., 40/60 and 50/50) guaranteed a potentiated release of Lovastatin from RYR inducing also a superior hypocholesterolemizing action both in terms of hepatocytes cholesterol production and inhibitory activity towards 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMG-CoA). The most effective one, in hypocholesterolemizing activity, in terms of inhibitory activity versus HMG-CoA reductase and hepatocytes cholesterol production, was the formulation obtained combining 40% of K-Carrageenan and 60% of Gellan gum.