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The partners
of the study

 
 
Collagen Solutions
 

 

Collagen Solutions develops, manufactures and supplies medical grade collagen components for use in regenerative medicine, medical devices and research. Our services offer product development and contracting manufacturing, which includes technology transfer and regulatory support. Collagen Solutions is publicly traded on the London Stock exchange (COS) and headquartered in Glasgow, Scotland with sites in the United States and New Zealand.

 

Project Participation

 

• Production of bovine collagen type I for clinical trial MPC delivery. COS will provide medical grade GMP bovine collagen for manufacturing of the final cell delivery product for use in clinical trials. Product quality will be verified.

• Development of xeno-free collagen. COS will develop and optimize a system for the manufacture of human collagen type I from human fibroblasts using either spin or hollow fiber cell culture. In spin culture, fibroblasts will be seeded on microcarriers within a media suspension. In hollow fiber culture, fibroblasts will be seeded on bundles of hollow, porous tubes through which media will circulate and provide cells with necessary nutrients. In both systems, the fibroblasts will produce xeno-free collagen, which will be harvested. The most efficient system will be scaled-up to a full GMP process in accordance with COS Quality Management System.  Equivalence of material and biological properties of human collagen to bovine collagen will also be demonstrated.

• Design of a device for MPC delivery. COS will work with UZH on the development of a syringe device that will mix and deliver MPCs with collagen at point of care.

 
 

 

Members

 

Grahame Busby, PhDR&D Manager

Josephine Wong, PhDResearch Scientist
Paracelsus Medical University of Salzburg
 

 

The Department of Transfusion Medicine (Chair Prof. Eva Rohde) at the Paracelsus Medical University of Salzburg (PMU) has a specialist expertise in the production and development of standard blood products in Austria. A focus of our interdisciplinary research activity is the development of novel stem cell-based therapies for use in regenerative medicine. As human platelet-derived growth factors and chemokines efficiently stimulate cell propagation the production of pooled human platelet lysate (pHPL) according to national and international regulatory requirements has been established. pHPL as a substitute for fetal bovine serum is produced in our good-manufacturing-practice (GMP) laboratory including specific quality control. This enables (GMP) compliant manufacturing of cell therapeutics without animal serum.

 

Project Participation

 

In MUS.I.C. the research team of Assoc. Prof. Dr. Katharina Schallmoser will provide pHPL for GMP-compliant manufacturing of muscle precursor cells (MPCs) and will cooperate with Scinus CellExpansion BV to develop optimized media formulations using modified pHPL for cell manufacture in a bioreactor system.

 

Members

 

Assoc. Prof. Dr. Katharina SchallmoserDeputy Head of the Department for Transfusion Medicine, Senior Scientist and Senior Physician, Head of the ‘Platelet Research’ Team, Head of the pHPL Laboratory

 

Dr. Sandra Laner-Plamberger, BSc MScPostDoc, responsible for infectious diagnostics of blood donors donors, co-worker in pHPL quality control
 
 

Dr. Michaela Öller, BSc MScScientific co-worker and technician, responsible for pHPL production, quality control and shipment

Dr. Linda Krisch, BSc MScScientific co-worker and technician, responsible for pHPL production, quality control and shipment
Scinus Cell Expansion B.V.
 

 

The main goal of Scinus Cell Expansion B.V. is to ensure that new cell-based therapies are available for the entire patient population. Manufacturing of cell-based therapies is traditionally a very costly process. Scinus Cell Expansion BV develops bioreactor technology that greatly reduces cost of the production process. Their proprietary technology is a closed system that can support culture of up to two billion cells for therapeutic use. Within MUS.I.C., Scinus Cell Expansion will focus on a cost-effective protocol for large-scale culture of muscle precursor cells.

 

Project Participation

 

Establish an efficient culture protocol for muscle precursor cells using the Scinus Cell Expansion system

Ensure GMP compliance of the new culture protocol

Dissemination and exploitation of project results

 

 

Members

 

Prof. Joost de BruijnCEO

Dr. Ruud DasSr. R&D Scientist

Rens RooslootSr. Process Engineer and R&D Technical Engineer

Wendy Tra, PhDR&D Scientist

Marijn DriessenProcess Engineer
Eberhard-Karls-University Tübingen
 

 

Regenerative Medicine, cellular therapy and tissue engineering are in the focus of experimental and pre-clinical research at the Department of Urology at the Eberhard Karls University in Tübingen. Different projects examines the possibilities to alleviate certain forms of bladder weakness by applying the patient’s own cells or even to heal urinary incontinence. Studies for treatment of stress urinary incontinence is in the focus of our studies.

 

Project Participation

 

In the current investigations, two different strategies are being pursued: on the one hand, we investigate if the injection of so-called mesenchymal stromal cells (MSCs) into the sphincter complex of incontinent patients may improve the muscle’s function. Mesenchymal stromal cells can be obtained without major side effects from bone marrow or adipose tissue of the patients. The MSCs can be expanded and characterized in the laboratory and prepared for later applications. The therapy with stromal cells is mainly based on the release of factors, which stimulate various healing processes in the patient’s body. These cells have been proven save thousands of times in treatments of other diseases worldwide. Their clinical efficacy, however, depends among other factors on the correct diagnosis, stage of the disorder and on other factors. In a second set of experiments we investigate the possibility of improving the muscle weakness of the urethra of incontinence patients by injecting muscle-derived cells. A part of these challenges will be investigated within the framework of the MUS.I.C. project.

In the subproject of the Tübingen research group, a new technology for transporting cells in the urethra is being employed and further developed: the cells will not be injected with needles, as in the past, but instead are sprayed into the target tissue. To this end, the cells are transported by a fine liquid jet. We hypothesize that a needle-free application will grant a better distribution of the cells and a more accurate dosage in the muscle targeted. The studies of the Tübingen team are designed as experimental investigations and as pre-clinical studies only. Further information on projects of the team from Tübingen in connection with incontinence therapy can be found on the Internet:

http://www.costbm1209.org/home.html
http://www.kfo273.org

 
 

Principle of needle injections: The injection cannula pierces the tissue, opens a channel and injects the solution with the active agent (e.g., cells) into the tissue. An injection channel remains behind.

Principle of water jet injections: The thin water jet penetrates the target tissue. The nozzle of the applicator does not penetrate the tissue. The active agent (e.g., cells) ist transported into the tissue through the water jet. Due to the tissue tension the channel of water injection closes.

 

Members

 

Prof. Dr apl. Wilhelm Aicher

Tanja Abruzzese
University of Zurich
 

 

The international research group «Laboratory for Urologic Tissue Engineering and Stem Cell Therapy» works in the field of tissue engineering (TE), one of the major approaches of regenerative medicine. It is a growing and exciting field of research. In combination with better understanding of structure, biology, physiology and cell culture techniques, TE may offer new treatment options for patients needing replacement or repair of an organ. The concept of tissue engineering has been applied clinically for a variety of disorders, for example artificial skin for burn patients, tissue engineered trachea, cartilage for knee-replacement procedures, injectable chondrocytes for the treatment of vesico-ureteric reflux, urinary incontinence and many more. The principle of classical TE is to dissociate cells from a tissue biopsy, to expand these cells in culture, and to seed them onto the scaffold material in vitro in order to form a live tissue construct prior to implantation into the recipient’s organism. In the appropriate biochemical and biomechanical environment these tissues will achieve their full functional potential and serve as native tissue equivalents. TE products may be fully functional at the time of treatment, or have potential to integrate and form the expected functional tissue after implantation.

The success in this promising field requires different scientific and clinical specialties. Therefore, we gathered a team with different expertise and backgrounds. The close collaboration within the team and with our collaborators at the ETH and in Europe offers the required multidisciplinary dimension to the vision we are embracing.

The TE approach has major advantages over traditional organ transplantation and does not face the problem of organ shortage. Tissue can be reconstructed from a generally readily obtainable biopsy and implanted with minimal or no immunogenicity. This eventually conquers several limitations, encountered in tissue transplantation approaches. Our research Laboratory is situated within the Department of Clinical Research at the University Hospital of Zürich. Our researchers are applying current scientific knowledge with the ultimate goal to translate this research into clinical treatments and aim at developing future medicine by providing new tailored treatments to patients.

 

Project Participation

 

In this project, we will combine clinical and basic research for an optimal result for our patients. In the clinic for urology at the University Hospital Zurich, we extract small samples of muscle tissue and transport them to our cooperation partner the Wyss center Zurich. Under most sterile conditions, we will extract cells from the muscle samples, grow them until a sufficient amount of cells and test for multiple quality criteria. We will re-transplant autologous cells into the sphincter muscle of participants and stimulate engraftment by neuro-electro magnetic stimulation. The UZH also functions as coordinator and is responsible for the smooth implementation of the collaborative project.

 

 

Members

 

Prof. Daniel Eberli, MD PhDLeading physician in Urology, USZ; Head: Laboratory for Tissue Engineering and Stem Cell Therapy, UZH; MUS.I.C. PI & Coordinator

 

 

Deana Mohr, Dr. sc. ETHClinical Project Manager and Coordinator, UZH and USZ

 

 

 
 

Regina Grossmann, MDHead Quality Assurance, CTC ZKF

Florian Schmid, MDAssistant Physician in Urology, USZ
 
 

Jenny Prange, PhDResearch associate: Lead GMP validation and production, UZH

Rosa Sousa, M.Sc.Research associate: GMP technician, UZH
 
 

Anka Baltensperger, MA, MPHStudy Nurse in Urology, USZ