RegTech-Verbundvorhaben: Validierungsstudie Chondrozytentransplantationstechniken, Teilprojekt Qualitäts- und Prognostikkriterien
- Bundesministerium für Bildung und Forschung (BMBF)
- Projektträger Jülich (PTJ)
According to the new tissue law, drug criteria are applied to patients' own cartilage cell transplants. In this research project, solutions are developed to answer questions on the identity (origin of the starting substances), purity (verifiability of the cell type) and efficacy (healing in the patient) of autologous cartilage cell products for each patient personally.
For several years now, it has been possible to heal defects in the cartilage layer of the joint by implanting the patient's cartilage cells. Thousands of patients have already been successfully treated with this cell transplant procedure. Recently, the treatment of diseased intervertebral discs has been added with a similar procedure, an option that could possibly improve the quality of life of tens of thousands of people by reducing pain.
Since January 2009, the new tissue law has been in force in Germany. It specifies how a transplant made from a patient's own cells in the laboratory is to be controlled and its efficacy tested. Since then, such a cell product has no longer been a transplant, but a drug. As such, it requires central authorisation in the EU.
The new tissue law did not take into account the fact that the technical feasibility of investigating individual cell preparations using typical drugs is currently limited or non-existent. The aim of this research project is to make it possible for each patient to personally answer the questions typical for a drug with regard to identity (origin of the starting substances), purity (verifiability of the cell type) and efficacy (healing in the patient). This objective is absolutely new. Previously, it was sufficient for a drug that its efficacy had to be verifiable in general and not in individual patients.
- Orthopädische Universtitätsklinik, Heidelberg
- TETEC AG, Reutlingen