The Fraunhofer Institute for Cell Therapy and Immunology IZI is certified as a GLP testing facility. Most recently, a preclinical study was carried out at the institute to test the safety of an ATMP for the treatment of cartilage damage to the knee. A drug for advanced therapies (Advanced Therapy Medicinal Product, ATMP) developed by BioPlanta GmbH was subjected to extensive tests under GLP conditions with regard to its potential undesirable biodistribution and tumorigenicity.
Our knee joints are covered by a layer of cartilage about five millimeters thick. By evenly distributing pressure and impact, it protects our joints and its smooth surface allows for smooth movement. However, this layer of cartilage wears out over the course of life and cannot regenerate itself. In addition to an acute injury from an accident, chronic improper strain in particular can permanently damage the knee joint cartilage. This is very painful for those affected and can lead to significant physical limitations. Left untreated, cartilage damage can develop into osteoarthritis of the knee joint.
Physiotherapy cannot heal cartilage damage, it can only alleviate it. Autologous cartilage therapy is currently available as an alternative to the implantation of a partial or full prosthesis of the knee joint. Here, the body's own cartilage cells are removed from the knee joint, multiplied in the laboratory under GMP conditions and then transplanted into the patient in order to heal the focal cartilage damage while largely restoring functionality. BioPlanta GmbH is pursuing a new approach that can be standardized and is less complex. Stem cells from umbilical cord tissue are used for this, as they are particularly adaptable to foreign immune systems. Implanted in the damaged knee, the aim is to stimulate the growth of new cartilage tissue. Before such a new ATMP is approved, however, various preclinical and clinical tests must first be completed and passed.
The preclinical tests under GLP conditions for this ATMP have now been completed at the Fraunhofer IZI. Director of Studies Dr. Jörg Lehmann, head of the Preclinical Development and Validation department, explains: “The data collected in the preclinical GLP study to assess the safety are an essential part of the application for approval for the ATMP and an essential prerequisite for the subsequent clinical trials of the cell therapy. « The Fraunhofer IZI has many years of expertise - it has been certified as a GLP test facility for such test studies since 2009 - and enables the planning and implementation of preclinical efficacy and safety test studies for new drug candidates (in particular ATMPs) and medical devices (according to ISO 10993) under GLP conditions.
Source: Press release Fraunhofer IZI from June 07th, 2022