What you need is patient cells. The certified laboratories of TETEC AG use autologous cells to produce biological cartilage replacement for degenerated joints and intervertebral discs. The company considers itself the global market leader in the knee cartilage market. This means that the rapidly growing company is excellently placed for introducing new products to the regenerative medicine market.
Autologous chondrocyte transplantation or ACT was still a relatively new procedure when TETEC was established in Reutlingen in 2000. ACT is the treatment of articular damage using cartilage cell transplants produced with autologous, i.e. a patient’s own cells. Back then, ACT was only just emerging and there was, of course, no long-term experience. However, research data and initial joint applications were so promising that the founders of the company, Dr. Jürgen Fritz and Dr. Christoph Gaissmaier, were convinced of the procedure’s medical and economic potential. In close cooperation with the NMI Natural and Medical Sciences Institute at the University of Tübingen in Reutlingen, Gaissmaier and Fritz, then at the BG Trauma Clinic in Tübingen, developed the basis of TETEC’s methods for treating cartilage defects. The company is now jointly managed by Christoph Gaissmaier and Dr. Klaus Maleck.
Articular cartilage has very poor regenerative qualities and defects can only be treated using laboratory grown cells. Then as well as now, the production of an autologous cartilage implant starts with a handful of cells from the articular tissue that needs to be replaced due to injury resulting from a fall or a sports accident. The cells are removed with a minimally invasive surgical procedure (arthroscopy) from a patient’s undamaged articular cartilage, expanded in the TETEC laboratory and applied to a three-dimensional, biphasic collagen-based matrix. It takes around three weeks to produce NOVOCART® 3D and deliver it to the hospital for transplantation. The NOVOCART® 3D transplant has several benefits:
There is no risk of rejection as the patient’s own tissue is being transplanted into the joint. In addition, the cells grow well in the pores of the three-dimensional collagen matrix. The material is also rigid enough for transplants of the desired size to be easily punched out of the laboratory-grown tissue. Another benefit is that the biphasic implant has a blood-tight and highly tear-proof boundary layer; the punched-out tissue graft can thus easily be implanted and fixed to the defect with just a few stitches.
Although NOVOCART® 3D and NOVOCART® Basic (three-dimensional collagenous matrix supporting biological repair of cartilage defects in the knee following microfracture) are very effective in treating cartilage defects, they are not suitable for all cartilage. Cartilage defects in the hip area and of intervertebral disc cartilage can only be treated with injectable implants. TETEC’s NOVOCART® Inject is an innovative injectable product for the arthroscopic reconstruction of cartilage. Gaissmaier: “This enables us to apply cells purely arthroscopically to articular cartilage defects. We are currently carrying out an observational study for the treatment of a femoroacetabular impingement where a bone spur develops around the femoral head or along the acetabulum. The bone overgrowth pushes the cartilage into the acetabular cup, leading to tearing and breakdown of the articular cartilage. This is one of the major causes of hip arthritis. The condition can be treated by removing the spur and subsequently regenerating the cartilage with NOVOCART® Inject. This product was also developed in cooperation with the NMI in Reutlingen. TETEC AG works with the NMI in numerous applied R&D projects that are funded through the BMBF.
One such product is for the regeneration of intervertebral disc cartilage and is also based on the patient’s own cells. The cells are isolated from the intervertebral disc tissue that is surgically removed in patients with herniated discs. The cells are enriched in the laboratory and the cell implant injected into the patient’s intervertebral disc using a dual-chamber syringe. One chamber contains a cell suspension and the other a biocompatible cross-linker. Similar to a two-component glue, cross-linking only starts when the two components are mixed together – in this case, immediately after injection. A gel that keeps the cells in the desired spatial distribution forms in the intervertebral disc. The effectiveness of this method is currently being investigated in a clinical study and the TETEC team expects the method to be ready for broad application within a few years.
Another BMBF-funded project that is part of the REGiNA health region explores the potential of human bone marrow stem cells to develop cartilage cells. This would then no longer require cells to be isolated from the defective cartilage. As bone marrow punctures are relatively easy to perform, the number of patients that could be treated with ACT would considerably increase.
In addition to cell products, intelligent biomaterials form an important pillar of TETEC AG, and will be expanded considerably over the next few years. Maleck explains: “We are working on a combination product consisting of albugel and hyaluronic acid for the symptomatic therapy of osteoarthritis. As cartilage wears away, synovial liquid loses its ability to lubricate the joint, leading to stiffness and pain. This can be improved with hyaluronic acid, but multiple injections are usually required as hyaluronic only remains in the joints for a few hours. “We want to combine hyaluronic acid with albugel so that the acid remains in the joint for longer. This would only require one injection and still achieve the same effect as with multiple injections.” Albugel is a hydrogel variant based on serum albumin and was developed at the NMI in Reutlingen.
TETEC soon hopes to obtain authorisation for marketing its ACT products in other countries. The company is currently preparing the launch of its products on the American market. “We have established a subsidiary, Aesculap Biologics, in the USA. This company is developing a NOVOCART® 3D equivalent. The production processes in the USA are slightly different from those here in Germany due to specific requirements of the American FDA. The American product is already undergoing clinical phase III testing and is therefore quite close to receiving marketing authorisation,” said Maleck.
The name of the subsidiary comes from the fact that the German company Aesculap AG has been a majority shareholder of TETEC AG since 2003. Aesculap itself belongs to B. Braun Melsungen AG, which is why TETEC is also part of the latter. Maleck emphasises that these connections improve TETEC’s access to market. “It already became obvious in 2003 that cell therapy products would undergo regulatory changes. We realised quite early on that a small company like TETEC would find it a lot easier to comply with the changes as the subsidiary of a big company.” With the new ATMP (ATMP = Advanced Therapy Medicinal Products) regulations coming into effect in January 2009, cell therapy products come under the same strict regulations as traditional drugs. Gaissmaier, from the point of view of a medical doctor, believes that this is unreasonable, especially as far as methods that involve autologous cells are concerned. “I would have thought that less red tape and regulations would be in the interest of patients,” concluded Gaissmaier.
Further information:TETEC Tissue Engineering Technologies AGDr. med. Christoph Gaissmaier (Managing Director)Dr. Klaus Maleck (Managing Director)Aspenhaustraße 1872770 ReutlingenTel.: +49 (0)7121 5148760Fax: +49 (0)7121 5148761E-mail: info(at)tetec-ag.de