Stress Urinary Incontinence (SUI) is a disease affecting over 200 million people worldwide. It represents a condition with a prevalence of 20-50% in women, thereby creating an immense socio-economic burden. The currently available treatment strategies entail various complications and offer only short-term relief to the patients.
Tissue engineering using autologous cells offers a feasible alternative for functional restoration of the damaged urinary sphincter muscle and represents an ideal treatment option that could reverse the underlying pathologic conditions. MUSIC aims at translating basic knowledge on regenerative medicine (RM) and stem cell therapy into the clinic by undertaking a “first-in-man” multisystem study using autologous muscle precursor cells (MPCs) in a combination with neuromuscular electromagnetic stimulation (NMES) in 40 female patients. We will carry out the specific tasks to prove safety and efficacy of the proposed novel multilevel treatment as well as reproducibility of the therapeutic effect.
Additional objectives are optimization of the advanced-therapy medicinal product (ATMP) towards totally xeno-free and facilitated manufacturing as well as the introduction of a novel injection technique for more efficient and precise implantation of the final product. Combining expertise, MUSIC features a unique infrastructure, including the knowledge of experts in the fields of RM, urology, cellular biology and biomaterials throughout Europe.
The MUSIC consortium has an exclusive opportunity to determine the validity of this MPC cellular treatment in combination with NMES and to further improve its feasibility and clinical efficacy. The ultimate goal is to significantly improve the patients` quality of life and to exploit a future commercial opportunity by expanding the know-how to various smaller RM centers and companies within Europe, thus, making personalized medicine using autologous cells a more feasible SUI treatment option.
The aim of the iP-Osteo project is to develop hybrid materials for regeneration of the large osteochondral defects in elderly people. The aim will be achieved by developing the active scaffolds that can attract the cells to the defect site needed the regeneration. To enable the regeneration of both bone and cartilage, bilayer scaffolds will be made.
The first scaffold layer will be made my electrospinning of biodegradable polymers and active molecules promoting the bone regeneration. The scaffolds will be optimized to have the needed composition, pore size and mechanical properties. The scaffolds will then be combined with hydrogels optimized for cartilage regeneration.
To enable effective healing of the tissue in patients with reducing regeneration capacity (elderly patients), active molecules will be encapsulated in both fibers and particles. The time-regulated release of the active molecules will lead to faster and more complete healing.
The Bioscale project, which will run from 2020 to 2023, involves cross-border collaboration with partners from the Netherlands, Belgium, Switzerland and Sweden.
Interactive batch records and smart algorithms will be developed by MyCellHub (Belgium) to reduce operator involvement and enable regulatory-compliant scalable cell production and in-depth bio-analytics. A new disposable culture container to grow non-adherent cells in suspension (a major CT culture method) will be developed by Scinus Cell Expansion, together with novel integrated sensor technology. Membrane filter technology allowing suspension culture will be developed by SEFAR (Switzerland) and incorporated into the suspension culture container.
NextCell Pharma (Sweden) uses a proprietary cell-selection algorithm based on functional and potency assays to achieve high-quality production of their MSC-based CT ProTrans, which is initially focused on type-1 diabetes. In this project, NextCell Pharma will integrate assays into the SCINUS workflow to optimise production of ProTrans and compare it to 2D culture. Scinus Cell Expansion will validate SCINUS suspension culture capability by producing non-adherent iPSCs (induced pluripotent stem cells).
In this project a new type of microcarrier will be developed that is optimized for efficient and effective bioreactor-based cultivation of iPSCs. IamFluidics uses its disruptive in-air microfluidics technology to produce advanced microcarriers. Novel coating modalities are designed by the group of Dr. Leijten at the University of Twente. Scinus, together with RiverBiomedics, are involved to further develop and utilize this technology for iPSC cultivation and production of iPSC-derived cardiomyocytes.
SCINUS Cell Expansion provides an innovative, controlled and cost-effective solution to automate cell culture processes.