Good news from Europe for knee cartilage damage patients. A simple and minimally invasive procedure for the treatment of cartilage defects in the knee was previously approved for the European market in 2012. German biotechnology company Amedrix GmbH has improved the product and a new injectible liquid gel form was given European CE certification in December 2013.
The treatment uses cell-free collagen implants and results in good autoregeneration of the cartilage defects.
Not only are cartilage injuries painful, but they may also 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.
Autologous Chondrocyte Implantation
Early alternatives to artificial knee joints were biological therapies, such as autologous chondrocyte implantation (ACI). In ACI, chondrocytes, the only cells found in healthy cartilage, are isolated from a small piece of the patient’s cartilage, expanded in the laboratory and after three weeks implanted into the defect, often in combination with a shaping matrix.
Over a period of time, the implanted cells reconstruct the damaged matrix until the injured cartilage is totally regenerated. But the cost of ACI treatment is high and is not always completely covered by health insurance. Not only that, but two surgical interventions are always required: one to remove the cartilage cells and a second to implant the proliferated cells.
Now, a one-step process is available.
Liquid Collagen Implant
“Our new product is arthroscopically injected as a liquid collagen implant. Once injected, the liquid collagen forms a stable cartilage replacement in minutes,” said Amedrix CEO Dr. Thomas Graeve.
Following the injection, cartilage and stem cells from the surrounding tissue travel into the implant and kindle the self-healing of the cartilage. Within a short time, there is a new and resilient cartilage.
“Patient MRI studies show that the cartilage defect is nearly completely filled after six months,” says Graeve.
Amedix works with the Fraunhofer Institute for Interfacial Engineering and Biotechnology to optimize purification and manufacturing processes per current legal regulations.
“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, of the Institute’s Good Manufacturing Practice unit.
“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.