Andrea Mazzoleni, vice president of Beike Europe, expresses his views on clinical trials based on stem cells

Andrea Mazzoleni (Beik EUROPE): RESEARCH AND DEVELOPMENT NECESSARY TO THE WORLD OF MEDICAL RESEARCH Andrea Mazzoleni, Vice-Chairman of Beike Europe, expresses his views on clinical trials based on cells staminali.INTERVISTA André Mazzoleni A, VICE PRESIDENT OF EUROPE Beik In recent days have been published by the International Society for Stem Cell Research (Isscr) recommendations for regulating the conduct of clinical trials based on stem cells and from the Vatican Instruction Dignitas personae. What do you think of these two documents? In science there are no miracles, and so we agree in saying no to false illusions and exaggerated clamor and especially no confusion engendered by 'excessive emphasis on the therapeutic properties of adult stem cells: the new international guidelines would first be clarified. The 60-page document indicates what are the procedures and tests that a treatment with stem cells must pass before reaching the testing on humans in a phase of general confusion where many false discoveries are announced as capable of changing the history of diseases currently without solution and having no drugs. Are often the same researchers to advance studies are far from clinical practice. Stem cells from umbilical cord administered in clinics are already doing to improve China's leading many sufferers of neurodegenerative diseases such as multiple sclerosis, ataxia, amyotrophic lateral sclerosis, muscular dystrophy, in addition to spinal injuries, certain eye diseases, l Alzheimer 'etc.. Yet these improvements do not mean anything for our "science", which is based on scientific publications often manipulated (as stated by the former director general of the British Medical Journal, Richard Smith). Indeed, often the patients who seek to bring to the attention of all their improvements are mocked and humiliated. Unfortunately, there are also many clinical centers, often disconnected from research in several countries, including European ones, which put patients at risk, taking advantage of the lack of awareness of the time needed for research to move from theory to practice. These structures must not delude patients with mirages unconvincing. The new Vatican document on bioethics ~ may seem a ban to medical progress, while there are also many si: positive affirmations. The Vatican document begins by stating that the''gene therapy''and '''in principle''morally permissible, subject to any other medical treatment, or if it avoids the aggressive treatment. However, Vatican warns against those who want to improve or enhance the genetic endowment''of''one person, because this entails a favor''eugenic''and''introduce an indirect social stigma against those who have no special talents.'' Concerning the therapeutic use of stem cells, are defined as legitimate methods that do not cause serious harm to the subject from which you extract and then in the event of withdrawal from the tissues of an adult organism from the blood of the umbilical cord during birth, from tissues of the fetuses died a natural death. By the Church is nourished by a more than justified concerns about technologisation beginning stages of life, speaking with a strong case against the manipulation of the embryo, its cloning for any purpose. No prohibition but a call to consider the fundamental human dignity. Beike How is oriented towards the western scientists and Italian in particular? Quite positive even in light of recent views expressed by some Italian scientists who clearly confirm what has been achieved and promoted by our Centers research and treatment since the beginning of the activity. At the inauguration of the new space at the San Raffaele Institute of Experimental Neurology (Inspe), which will house 200 thousand square meters of workshops devoted entirely to basic research and clinical research for the treatment of this serious neurological diseases now considered incurable Giancarlo Comi, Professor of Neurology at the University Vita-Salute San Raffaele and director of the Department of Neurology San Raffaele Scientific Institute and University of Inspire has in fact said "The new center is distinguished internationally both for number of dedicated people, more than 100 physicians and researchers, both in size and laboratories, but also the research approach is unique: through translational medicine, in fact, we try to move more quickly the gains of research Basic to the bedside. "The greatest strength of Beike, a key factor that differentiates us from other research initiatives, is that we specialize for years in its translation to clinical application. We know that scattered in the various countries of the world there are many Patients may have a better quality of life and that may even hope for a longer life thanks to the technologies at our disposal, but who find themselves precluded these possibilities for obstacles of a political, religious or bureaucratic. Well, our goal is to help those people. We chose biotechnology research that is the most advanced in the world - that of stem cell therapy - and apply it clinically at a rapid pace. This enables the Beike to achieve its mission, namely: "Move fast results the most advanced biomedical research within the practice, and this now makes it to the health of human beings around the world. "Corriere della Sera on Sunday Nov. 30 Gianvito Martino Director of the Division of Neurosciences Institute San Raffaele in Milan, further states: We have underestimated the influence of tissue in which to transfer these cells, dazzled by the mirage of omnipotence they have not understood that the stem cells are perhaps the main catalyst for regeneration. This hypothesis has been advanced recently by prof. Sean Hu, CEO of Beike, and largely confirmed by our research. We note finally that, in the meeting, called adult stem cells: perspectives for research and therapeutic applications of 21 November, discussed the clinical applications and the encouraging outlook therapeutic stem cells. Many degenerative diseases and ischemic damage induced by trauma are increasingly being treated with stem cells that have shown an incredible therapeutic potential. Furthermore, encouraging research on stem cells from umbilical cord, placenta, and the most recent induced pluripotent stem (reprogrammed adult cells into stem cells) are an issue, but potential therapeutic alternative. This has led to the need to establish structures and appropriate regulations for their handling and preservation for later use in the treatment of an increasingly wide range of diseases. The recently established an "Advisory Committee of Experts of stem cells" and a special "Commission for data security and monitoring" with the task of assessing future research carried out by Beike fully respond to these comments. How the cells act cells? Stem cells are cells whose fate is not decided yet, may give rise to several different types of cells through a process called differentiation. The cells communicate with each other through chemical signals, exchanging information and instructions. It is these chemical signals to tell a stem cell when activated: they are produced by neighboring cells during development or release of substances due to damage or lack of certain cells. Identify the instructions for stem cells is one of the key research in the laboratory to reproduce these mechanisms. In this way it will in future obtain in vitro tissue for transplantation, or even to exploit these molecules for therapies to be administered in humans to stimulate growth subsidiary of a damaged organ. goals are still far from reach, but Current knowledge suggests that there is not science fiction. Several experiments show however that the stem cells from cord blood are more powerful and with a shorter doubling time in culture. As previously mentioned scientists Beike Biotechnology Co., Ltd postulate that the effect benefits of treatment may also be mediated by factors and are currently conducting further research to confirm the theories. What precautions are taken for prevention of disease and treatment steps take place in safety? The use of stem cells in their procedures Beike Treatment is limited to those obtained after cultivation of cells from blood taken from umbilical cord at delivery. In particular procedure is activated and then double check that offers a warranty greater than the parameters normally used by other biotechnology companies, thanks the type of operative protocol implementation in hospitals run by Beik, exclusive of the ethical problems of using cells from embryos. The clinical applications consist of three injections of stem cell subsets: CD34 +, CD133 and mesenchymal. The CD34 + and CD133, as has been shown in numerous studies are prone to become tissue, mesenchymal cells have been shown to be prone to become many cell types, including chondrocytes (a basic unit for the renewal of the fabric, particularly cartilage), liver and kidney interactions. Laboratory tests indicate the mesenchymal stem cells, combined with other cells, just as CD34 + and CD133, are likely to revive the process of transformation of other stem cells. In addition, for each sample UCB achieved are documented: medical history of the infant and parents concerned with the absence of diseases such as HIV I / II, HBV, HCV, syphilis, etc., the mother's blood tested for communicable diseases UCB samples that have positive results are removed and disposed of correctly all the individual units of UCB stem cells are correctly classified for ease of identification and traceability Each example is accompanied by corresponding document: Code ID Total mononuclear cells (MNC) Collection Time Data collection model name UCB UCB Checks are made to the Central Bank of the blood and, for safety, repeated in our laboratories using the criteria dell'AABB (American Association of Blood Banks). How would you answer those who accuse you of false hopes? First let me point out that as Beike Europe received an average of ca. 200 requests per month and, according to treatable diseases and contra, we regret to say no more than 60% of requests. There are specific requirements for access to treatment and for this reason we implement a precautionary procedure well-defined with the required information needed for our medical staff decided that the possibility of processing of cases submitted to it: How it is completely free. Of the almost 4,000 patients around the world who are subjected to treatments based on stem cells, about 70% -80% are satisfied with the improvements that have been awarded, depending on the disease. This percentage is increasing because we consider each case professionally, giving a favorable opinion only when improvements are conceivable and no contraindications. If our medical staff believes that there will be substantial benefits to treatment say it and if possible advise on possible alternatives. While we can not guarantee an improvement in our treatment, consisting of several injections of stem cells, accompanied by a comprehensive rehabilitation program daily tends to get the maximum possible through expertise and professionalism derived from years of experience