The public and interested parties long remained hidden, that at the Technical University of Berlin, a most interesting hair model is developed that could bring the hair back in the foreseeable future.After a few weeks ago a lot of information has been spilled into the press, we want to try in an online interview with Dr. Gerd Lindner, introduce the project, but also the opportunities and the necessary steps yet. We would like to take this opportunity to thank R. Azar of the iFUE Hair Clinic Berlin, who is working with Dr. Lindner and has made contact.
Dr. Gerd Lindner Head "organ models & Imaging" at the Institute of Biotechnology at the Technical University of Berlin. The Institute, headed by Prof. Dr. Roland Lauster has, inter alia by the Federal Ministry of Education and Research (BMBF) a promotion for the development of " multi-organ bioreactors in chip format received. "Dr. Lindner studied biochemistry at the Free University of Berlin and has become the subject of hair growth induction worked for his doctorate at the Charité in Berlin by growth factors. After he has developed artificial skin systems for the safety testing of substances at the Federal Institute for Risk Assessment in Berlin, he was at the Department of Medical Biotechnology, TU Berlin develop a process in which, from hair follicle stem cells an artificial skin can produce. At the moment is to create a micro-hair follicles, which could potentially be used in the future for hair transplantation in hereditary hair loss.
We are pleased that Dr. Lindner would like to answer a few questions that are sure to see concrete against the background that many sufferers are urgently waiting a help with their hair loss problem.
There are a number of publications with different emphasis, however, is not easy to understand here the exact procedure. could you briefly describe the expiry of Haarfollikelzüchtung for your technology to us all:
In our method, the Haarfollikelzüchtung is the world's first and only procedure in which autologous cells engineered to körpereigene- -so special "hair germs" are assembled.
First, while the subjects / patients are a few hair follicles taken from which the required cells are isolated. This will greatly multiplied, composed under special conditions again and covered with a biological matrix / protective layer so as to form inductive hair germs. This "Neopapillen" are small, hair-producing "Mikrofollikel" build already in a position in the culture dish. We have used this method just in a scientific journal (
Journal of Biotechnology described) in more detail.
We assume that this Mikrofollikel are also in the scalp able in the future to be able to produce a new hair.
It will therefore always be necessary to remove some hair, and then replace it in the desired shape?
Yes, exactly (the small units producing our hair so) will be used as a FUE -Haartransplantation even with our method with small 0.9 mm biopsies hair follicles.However, depending on the degree of alopecia a much smaller number will have to be removed. Up to 30 biopsies are expected for 10000 hair germs must be taken, not even pinhead but are large. It's painless, leaves no visible scars and is done in a few minutes.
What is the most difficult step in the process?
The most difficult step is the preparation of the required cells, since this must be done under the microscope and it takes a lot of experience and especially for the coating with the biological matrix / protective layer. All other steps are indeed complex and expensive, because they must be performed in a clean room laboratories, but biotechnological standard.
How far are you? Does it work in animal models?
We have progressed so far with the development of this technology that preclinical animal studies and clinical trials on humans can be processed after acquisition of adequate financing in a detailed planned test program now. We are very confident that this technique is successful because at the development of hair shafts even succeed in vitro. In contrast to the human skin are here essential supporting factors such as nerve, support and blood supply does not exist yet does Mikrofollikelbildung.
Biotechnology is of course synonymous with progress on the one hand, for large safety concerns on the other side. How do you assess because from today's perspective, the safety of the procedure, a?
Security Studies Aderans (US) or Intercytex (GB) and other companies for the implantation of autologous cells in the scalp have promoted no identifiable risks to light in recent years. From our vantage point, therefore, our technology is safe, because the body's own material is used and this is not such as genetically modified. Finally, the reliability of the method is of course subject of clinical trials for our grafts under the enormous strict European ATMP (advanced therapy medicinal products) rules must be performed before a first application on the patient. If the trials are successful, the process has met the world's highest safety standards.
Let's talk about a very decisive question: You are working to make the procedure available to patients? And more importantly, how long will it take?
Course is to provide objective of our development all this treatment option available. It will be gentler than any previous process and it may also cases can be treated at which lack sufficient donor hair currently there are no methods available. For our test program we need rigorous project management at about 5 years for all of the safety and efficacy of the grafts questions to clarify solid. In the course of the program, we treat in clinical trials already a significant number of those affected. An authorization may be achieved earlier than 5 years after the start, so far, however, we are still looking for partners for the necessary funding.
Of course, it is much too early, but still a very important question: the procedure for a normal person will be affordable?
It is anticipated that the market price of admission is first is rather high. Years of development costs and the biotechnological production are the main price driver here. However, as well as the transplantation method comes in the mass application, the cost of the utilization of production facilities and the automation of manufacturing are likely to be significantly reduced.
