Dr. Michaela Endres is the CEO and Head of Research & Development at TransTissue Technologies, and has over 20 years of experience in tissue engineering. As a bioengineer, she specializes in developing cell-based and cell-free products for tissue regeneration. During her thesis, she worked on biological trachea reconstruction. She also coordinated clinical studies, managed several research projects, and participated in an EU FP7 project on a 3D human tissue disease platform to enable regenerative medicine therapy development. Additionally, she played a significant role in developing two products (a medical device and a medicinal cell product) until market maturity.

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Could you describe the main tasks that TransTissue Technologies is working on in INKplant?

INKplant is a research project that aims to advance the field of personalized medicine by tailoring medical treatments to the individual needs of each patient. The EU has invested significant funds in the project because it recognizes the potential benefits of personalized medicine in addressing the complex health challenges faced by an aging population. The project aims to improve patient outcomes, reduce healthcare costs, and accelerate the development of new treatments.

TransTissue is a Biotech company that specializes in tissue engineering and regenerative medicine solutions. By developing personalized tissue replacements, TransTissue can help address the growing demand for effective and safe medical treatments, especially in areas such as joint defects that are more common in the aging population.

TransTissue's specific tasks within the INKplant project involve developing personalized implants for the treatment of meniscal and osteochondral defects. In addition, TransTissue, in its role as a company experienced in regulatory affairs, identifies potential regulatory hurdles from the beginning of the project to avoid pitfalls and therefore took the lead on Work Package 8.

Overall, the INKplant project and TransTissue's contribution to it represent an important effort to advance the field of personalized medicine and develop new solutions that can address the complex health challenges of an aging population.

How do you see the role of 3D printing in the medical industry and what excites you about the future of regenerative medicine?

3D printing is poised to transform the field of regenerative medicine by allowing the development of personalized implants, tissue replacements, and even organs. One of the most significant advantages of 3D printing is its ability to produce complex structures with precise geometries and customized shapes, which can be difficult to achieve with traditional manufacturing techniques. With 3D printing, it is possible to create patient-specific implants that fit perfectly and integrate seamlessly with the surrounding tissue, leading to better outcomes and faster recovery times.

In addition to 3D printing, there are numerous other medical technologies that are promising and have the potential to improve patient outcomes. Virtual reality technology, for example, can be employed to train medical professionals in real situations. Wearable devices with sensors can also be used to monitor patients and provide real-time data to healthcare providers, allowing for earlier interventions and more tailored treatments. These emerging medical technologies represent a significant step forward in personalized medicine, with the potential to change the way we deliver healthcare and improve the lives of patients.

What would you say have been  TTT’s most notable achievements?

TransTissue Technologies GmbH is a pioneering company in the field of tissue engineering and regenerative medicine. The company has achieved many notable successes, particularly in developing biotechnology solutions for patients with joint tissue defects.

Some of TransTissue's key accomplishments include the development and patenting of one medical device and one cell-based product both used for the treatment of joint cartilage defects, using innovative techniques in combination with absorbable implant solutions. Additionally, the company has successfully translated pre-clinical research into the clinical routine and established strategic partnerships with academic and industry partners.

Overall, TransTissue's contributions to the field of tissue engineering and regenerative medicine have been significant, with the potential to positively impact the lives of many patients.

What are the challenges that TTT faces in the field of tissue engineering and regenerative medicine, and how does it plan to overcome them?

Tissue engineering faces several challenges, particularly in the orthopedic field, where developing engineered tissues should effectively mimic the complex biomechanics and microenvironment of native tissues. For example, cartilage tissue has a specific structure and composition that is challenging to reproduce in a scaffold and ensure proper integration with surrounding tissues.

Furthermore, ensuring that tissue replacements are safe, effective, and cost-efficient is another challenge. Regulatory challenges in developing tissue engineering solutions are also significant, as the regulatory pathway for tissue-engineered products can be complex and time-consuming, requiring extensive preclinical and clinical studies to demonstrate safety and efficacy.

TransTissue has developed a range of strategies to overcome these challenges, including ongoing research and development efforts to optimize its tissue engineering techniques and products. This includes developing advanced scaffolding materials and techniques to improve the differentiation and maturation of cells into functional tissues. Additionally, the use of bioreactors to mimic the microenvironment of native tissues can also be a solution. The 3D multi-material printing technologies also help us to overcome the problem of mimicking complex tissue structures.

TransTissue also partners with academic institutions and industry leaders to collaborate on research and development projects and seeks funding from the government and private sectors to support its research efforts. Moreover, the company places a strong emphasis on working closely with regulatory bodies to ensure that its products meet all necessary safety and efficacy standards, and adheres to good manufacturing practices to ensure consistent quality and compliance with regulatory requirements.

Can you tell us about any significant advances that have already been made in the INKplant project?

The INKplant project has made significant advances in the field of tissue repair through the development of various biocompatible ink formulations for 3D printing. These ink formulations enable the printing of complex structures with exceptional accuracy, opening up new possibilities for creating functional tissue constructs. Alongside the ink formulations, the project has also made notable progress in printing biomaterials that possess a range of desirable properties for tissue engineering, such as biocompatibility, biodegradability, and mechanical strength.

Another noteworthy accomplishment of the INKplant project is the successful demonstration of 3D printing scaffolds in prototypes to replicate meniscal and osteochondral defects. The scaffolds have demonstrated considerable potential for effectively covering defects of the appropriate size.Overall, the INKplant project represents a significant step forward in the development of printed implants using 3D printing technology.

Can you walk us through the process of developing a tissue replacement or a cell-free implant, and what role does TransTissue play in this process?

Developing a tissue replacement or a cell-free implant involves a multi-step process that typically includes the following steps: identification of the target tissue, selection of scaffold materials, development of biomaterials, testing the structure for biocompatibility and biomechanical properties, and finally implantation tests to show its safety and efficacy. In parallel, quality management is set up to define parameters such as quality markers which are used to evaluate product quality during the manufacturing process.

The scaffold material should promote cell attachment, proliferation, differentiation, and provide the necessary mechanical properties. The scaffold can be made from natural, synthetic, or combination materials, and can be designed to have specific pore sizes and geometries. Developing an osteochondral implant is a good example of the tissue replacement process. The implant should substitute the cartilage on the surface and the underlying bone in the knee joint. Two phases of hard and soft biomaterials can mimic the osteochondral tissue and promote the attachment and growth of both cartilage and bone cells. The scaffold is seeded with both chondrocytes and osteoblasts or their precursor cells, such as mesenchymal stem cells.

The seeded scaffold is cultured in a specialized bioreactor under appropriate conditions to allow the cells to grow and differentiate into both cartilage and bone tissues. The tests can involve applying mechanical stimulation to the scaffold, such as compression or shear stress, to mimic the natural environment of the joint tissue. Once the osteochondral model is fully developed, implantation testing is typically done in animal models before moving on to human trials. Cadaveric samples are sometimes used to assess the suitability of the implant before animal testing.

How do biocompatibility studies and quality management play a crucial role in developing tissue replacements and cell-free implants, and what is TransTissue's expertise in this area?

Biocompatibility studies and quality management are essential to ensure that tissue replacements and cell-free implants are safe and effective. Biocompatibility studies assess how well a material interacts with living tissue, excluding potential cytotoxicity, sensitization, genotoxicity, carcinogenicity, and reproductive toxicity. Quality management ensures that every step of the manufacturing process, from raw materials to the final product, meets the required standards for safety and efficacy.

TransTissue is a company that has been involved in the development of two biomedical products that are already in the European Union market. The company has extensive expertise in conducting biocompatibility studies and quality management for tissue replacements and cell-free implants. We use advanced techniques, such as in vitro tests, animal models, and clinical trials, to test the safety and biocompatibility of our products. A rigorous quality management system, including ISO 13485 certification, ensures that TransTissue products meet the highest standards of safety and efficacy. Through our expertise and commitment to ensuring that our products are safe and effective, we have built trust in the field which ultimately benefits the patients who receive our tissue replacement products and cell-free implants.

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