Cartilage damage is the most common form of joint disease. Recently, the German biotechnology company Amedrix has developed collagen implants for damaged cartilage that allow cells from surrounding tissues to migrate into the implants. The processes for collagen purification as well as GMP-compliant manufacturing of the collagen implants were developed in cooperation with the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB.
Five million people suffer cartilage damage to the knee every year in Germany. Cartilage injuries are not only painful; they can lead to osteoarthritis decades later. In the course of the disease, the protective shock absorbing cartilage that covers the bone within the joint slowly is removed until the bone is finally exposed, typically requiring an artificial joint replacement.
An early alternative to the artificial knee joint are biological therapies, such as autologous chondrocyte implantation (ACI), where chondrocytes are isolated from a small piece of cartilage of the patient, expanded in the laboratory and after three weeks implanted into the defect, often in combination with a shaping matrix.
Over time, the implanted cells will reconstruct the matrix until the injured cartilage is completely regenerated. However, the cost of treatment is high and not always fully reimbursed by health insurance. In addition, two surgical interventions are always required: one to remove the cartilage cells and a second to implant the proliferated cells.
The German biotechnology company Amedrix GmbH developed a one-step minimally-invasive surgical procedure for the treatment of cartilage defects using their cell-free collagen implants – with comparable good autoregeneration of the cartilage defects. Their first gel-like implant was approved for the European market in 2012. In December 2013 a further development of this product, a liquid application form, received European CE certification, which ensures that the implant is safe and medically-technically efficient.
"Our new product is arthroscopically injected as a liquid collagen implant. Once injected, the liquid collagen forms a stable cartilage replacement in minutes", describes Dr. Thomas Graeve, CEO of Amedrix. After injection, cartilage and stem cells from the surrounding tissue migrate into the implant and stimulate the self-healing of the cartilage. Within a short time, the result is a new and resilient cartilage. “Patient MRI studies show that the cartilage defect is nearly completely filled after six months", says Graeve.
In order to optimize the purification and manufacturing process according to current legal regulations, Amedrix cooperates with the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB in Stuttgart. The institute supports a 215-square-meter Good Manufacturing Practice (GMP) unit certified for developing production processes for medical devices or cell-based tissue-engineered products.
"Our specially trained staff work together with Amedrix employees to isolate collagen protein from animal tendons and then process the collagen in the IGB clean rooms," explains Markus Schandar, head of the GMP Group.
The Fraunhofer IGB has also applied for the manufacturing authorization of medicinal products on behalf of industrial partners. "Previously, we have developed GMP processes for autologous endothelial cells for the colonization of a vascular prostheses, autologous cartilage grafts and autologous bone marrow stem cells for regenerative medicine under GMP conditions and according to the guidelines of the Medicines Act", according to Schandar.
Markus Schandar | Fraunhofer-Institute
How brains surrender to sleep
23.06.2017 | IMP - Forschungsinstitut für Molekulare Pathologie GmbH
A new technique isolates neuronal activity during memory consolidation
22.06.2017 | Spanish National Research Council (CSIC)
An international team of scientists has proposed a new multi-disciplinary approach in which an array of new technologies will allow us to map biodiversity and the risks that wildlife is facing at the scale of whole landscapes. The findings are published in Nature Ecology and Evolution. This international research is led by the Kunming Institute of Zoology from China, University of East Anglia, University of Leicester and the Leibniz Institute for Zoo and Wildlife Research.
Using a combination of satellite and ground data, the team proposes that it is now possible to map biodiversity with an accuracy that has not been previously...
Heatwaves in the Arctic, longer periods of vegetation in Europe, severe floods in West Africa – starting in 2021, scientists want to explore the emissions of the greenhouse gas methane with the German-French satellite MERLIN. This is made possible by a new robust laser system of the Fraunhofer Institute for Laser Technology ILT in Aachen, which achieves unprecedented measurement accuracy.
Methane is primarily the result of the decomposition of organic matter. The gas has a 25 times greater warming potential than carbon dioxide, but is not as...
Hydrogen is regarded as the energy source of the future: It is produced with solar power and can be used to generate heat and electricity in fuel cells. Empa researchers have now succeeded in decoding the movement of hydrogen ions in crystals – a key step towards more efficient energy conversion in the hydrogen industry of tomorrow.
As charge carriers, electrons and ions play the leading role in electrochemical energy storage devices and converters such as batteries and fuel cells. Proton...
Scientists from the Excellence Cluster Universe at the Ludwig-Maximilians-Universität Munich have establised "Cosmowebportal", a unique data centre for cosmological simulations located at the Leibniz Supercomputing Centre (LRZ) of the Bavarian Academy of Sciences. The complete results of a series of large hydrodynamical cosmological simulations are available, with data volumes typically exceeding several hundred terabytes. Scientists worldwide can interactively explore these complex simulations via a web interface and directly access the results.
With current telescopes, scientists can observe our Universe’s galaxies and galaxy clusters and their distribution along an invisible cosmic web. From the...
Temperature measurements possible even on the smallest scale / Molecular ruby for use in material sciences, biology, and medicine
Chemists at Johannes Gutenberg University Mainz (JGU) in cooperation with researchers of the German Federal Institute for Materials Research and Testing (BAM)...
19.06.2017 | Event News
13.06.2017 | Event News
13.06.2017 | Event News
23.06.2017 | Physics and Astronomy
23.06.2017 | Physics and Astronomy
23.06.2017 | Information Technology