Swiss Medical Devices for Autologous Regenerative Medicine: From Innovation to Clinical Validation

Abstract

Regenerative medicine, based on the use of autologous tissues and embryonic, stem or differentiated cells, is gaining growing interest. However, their preparation, in a manner compliant with good practices and health regulations, is a technical challenge. The aim of this manuscript is to present the design of reliable CE marked medical devices for the preparation of standardized platelet-rich plasma (PRP) and other autologous biologics intended for therapeutic uses. There are numerous PRP isolation processes. Depending on the methodology used, PRP composition varies greatly in terms of platelet concentration, platelet quality, and level of contamination with red and white blood cells. This variability in PRP composition might affect the clinical outcomes. The devices presented here are based on a specific technology, patented all over the world, that allows the precise separation of blood components as a function of their density using thixotropic separator gels in closed systems. This allows the preparation, in an automated manner, of leukocyte poor PRP with a standardized composition. Production of different forms of PRP is a clinical asset to suit various therapeutic needs. Therefore, we are offering solutions to prepare PRP either in liquid or gel form, and PRP combined with hyaluronic acid. These biologics have been successfully used in many different therapeutic domains, resulting in more than 150 published clinical studies. We also developed the CuteCell technology platform for cell culture expansion for further autologous cell therapies. This technology enables the safe and rapid in vitro expansion of cells intended for therapeutic use in good manufacturing practices (GMP) and autologous conditions, using blood-derived products as culture media supplementation. We summarize in this article our 20 years’ experience of research and development for the design of PRP devices and, more recently, for PRP combined with hyaluronic acid.

Recent Achievements in the Development of Biomaterials Improved with Platelet Concentrates for Soft and Hard Tissue Engineering Applications

“…In recent years, numerous studies have shown the suitability of autologous biocompatible materials in regenerative medicine [6]. Among them, blood-derived products generally described as platelet concentrates (PCs) have been largely studied as useful therapeutic agents [7][8][9][10].…”

“…1 PRP-platelet-rich plasma; 2 COMP-Cartilage Oligomeric Matrix Protein; 3 H-PRP-platelet-rich plasma obtained from healthy young males (age ranging from 23 to 33 years); 4 OA-PRP-platelet-rich plasma obtained from older male patients (age ranging from 62 to 85 years) who suffered from severe knee osteoarthritis (OA); 5 BMSCs-bone-marrow-derived stem cells; 6 ADSCs-adipose-derived stem cells; 7 LAA-L-ascorbic acid.…”

“…• Electrospun PCL + AF-MSCs 6 and PRP significantly enhanced the deposition of type I collagen and the formation of blood vessels in rats with defects in the cranial bone [105] Poly-ε-caprolactone (PCL)/β-tricalcium phosphate (β-TCP)/ gelatin (Gel) 3D-printed scaffold • PRP 1 loaded after the fabrication process (details were not provided)…”

How to make full use of dental pulp stem cells: an optimized cell culture method based on explant technology

“…Tissue engineering aims to replace, repair, or regenerate organs and tissues damaged by trauma, disease, or congenital malformations ( Sahakyants and Vacanti, 2020 ), such as deficiencies in skin, bone, nerves, and tendons ( Gomri et al, 2022 ), by creating living human structures. Due to recent developments in cell biology, biomaterials, and other subject areas, research on tissue engineering has made great strides.…”

Effect of tetracycline hydrochloride application on dental pulp stem cell metabolism–booster or obstacle for tissue engineering?

“…Tissue engineering is currently one of the fastest growing fields in medical and dental science. By applying principles of tissue engineering, trauma or genetic defects of tissue including skin, nerve, tendon or bone can be regenerated ( Gomri et al, 2022 ). Tissue engineering generally consists of three basic components: suitable stem cells, scaffolds, and growth factors ( La Noce et al, 2014 ; Anitua et al, 2018 ).…”