Herniated disc - new therapies in view
The therapy begins with the chondrocytes are isolated from the disc tissue of the patient. At the tissue reach the doctors when a herniated disc so huge problems that must be surgically removed. The intervertebral disc cells from the incident be propagated in the laboratory and after a few weeks, embedded in a new biomaterial, again injected into the disc in order to regenerate the tissue here. "We start with a few hundred thousand cells are needed finally some million. The exact cell dose determined by the treating physician, the maximum injection volume are currently 2,5 milliliters of up to five million cells, "explains Prof. Dr. Jürgen Mollenhauer, research and development manager TETEC AG. The company has long been a development partner of the NMI in terms of cell therapy and already leading provider of cell-based cartilage grafts for the knee.
Together with the cartilage cells a pain retardant biomaterial is injected into the intervertebral disc, where it solidifies, fixing the cells and the disc supports biomechanically. The injection liquid consists of two components which are mixed in a special syringe during injection. One component contains the cells and other biomaterials, the other one crosslinker. In the disc therefrom forms a hydrogel with cartilage tissue-like properties. The hydrogel is a marketable TETEC product. At the primary development team today Cellendes GmbH was involved, a spin-off of the NMI, which specializes in hydrogels.
The first patients are now being treated with the new procedure for intervertebral disc regeneration - scientifically supported by the NMI and its partners. This work is funded with around six million euros as part of a BMBF project. While TETEC AG is responsible for the clinical study, provides the production technology and delivers the cell transplants to the doctor, the NMI team is responsible for the preclinical and clinical accompanying analyzes. “Our primary project goal is the development of quality markers. In the medium term, we also want to develop prognostic markers that can be used to predict whether a successful treatment is even possible, ”explains Dr. Karin Benz, project manager at the NMI.
With the marker development, the NMI is advancing personalized medicine. "We analyze from all stages of the cell culture and after transplantation periodically blood and urine of the patients. For this, we put together a suitable assay system to detect different classes of biomolecules, "explains Benz. "The combination of patient and cell culture data, we put together a package that is to describe the safety, efficiency and effectiveness of the new treatment. Validating markers to assist us in the project end, to apply for admission under the guidelines of the Medicines Act, "Mollenhauer concludes.
The lead study center is the Innsbruck University Hospital (Prof. Dr. Claudius Thomé). Involved are also German clinics, z. B. the BG Clinic in Halle and the BG-Trauma Center Murnau. Currently, eligible patients are still being sought, wishing to participate in the study. "All patients are followed up to three years by function controls, surveys on quality of life improvement and by modern imaging techniques (MRI) brain scans," said Mollenhauer. In the long term, patients are expected to benefit, which is not available through an operation incident tissue for cell isolation. Within a project of the Health Region REGiNA the NMI and TETEC explore the use of stem cells from the bone marrow. They are to be injected and propagated for tissue regeneration in the intervertebral disc.
Source: Tübingen [NMI]
