Stem Cells and Regenerative Therapies – How to extract the essence
The process of finding and developing new drugs is long and costly. It takes years and millions of dollars for a single new drug from the stage, in which a candidate molecule to the final stage of regulatory approval for marketing has been identified to be developed. The new era of stem cells and regenerative medicine not shorten this process. On the contrary, it presents new challenges in the road through the translation into approved therapies. The challenges are due to the completely newand other structure of the final product. The patients treated with living cells instead of active molecules. The way to develop new cell-based therapy is just as long, complicated or expensive than the road to conventional drugs to develop.
The amount of information in the media, both professional and popular, is huge. However, the biggest part of it is so interesting and supportive for the further development, not applicable to the current needs of the patient. If we want to assess the currentPotential of a new therapy, the most important parameter is how close it is clinical use. Practically, we want to know whether the therapy to treat diseases in humans already. Such treatment may be experimental, both in the initial phase, or ultimately approved by regulatory authorities and made available by companies, clinics and hospitals.
Let's look at the different stages of development to look, and so capable of the most important tasks for this simple identificationPrinciple. Research is conducted at the molecular and cellular level, as well as in experimental animal models. Such research produces large amount of data, and lay the basis for the identification of new modules of therapies. Once a promising candidate identified, the process of drug-or cell-based therapy begins. It must be the full characterization, understanding the mechanism of action, the optimization of production in large-scale, thorough analysis of the safety profile, establishing quality control and testingmore. The first stage is a general and theoretical research, while the second is a pre-clinical development. Once this stage is reached, the product is ready for clinical studies in the following submission and approval by the regulatory authority. This third stage is called the clinical development. The clinical trials are conducted in three phases and, if successful, received approval for marketing. A product or process that are currently being tested in clinical trials may be better assessedfor the current application. As in the clinical phase of development is appropriate for practical purposes, although only a few products will be approved as safe and effective, and for clinical use. The clinical phase of development is about 2 to 5 years, sometimes longer.
In some countries it is legal and possible, cell-based treatment, even before the full extent of the clinical trials have been completed. Clinics and hospitals in these countries for the treatment of patientslife-threatening and chronic diseases before a thorough examination and approval by the regulatory authorities in the U.S., Europe or other countries. Most of these clinics do not perform or publish systematic clinical studies, but they generally used information about the technologies and therapeutic approaches. Can this be considered "tested in human patients? The answer is no, but it is up to the patient to decide whether to risk to take with all its implications, rather than waittherapy approved.
The most reliable information about ongoing clinical trials is found in the FDA (U.S. Food and Drug Administration) database – Clinicaltrials.gov. Although US-based, most clinical studies from many other countries as well in this comprehensive site, which also published an efficient internal search option. However, pilot and Phase I trials are usually not listed. The results are based on clinical studies can be found found in the known scientific literatureData base site of the U.S. NIH (National Institutes of Health) PubMed Ncbi.nlm.nih.gov. Again, the relevant clinical data will be difficult to extract from the wealth of scientific information, and it is mostly used by professional scientists. Major medical centers are also current information on scientific achievements, together with clinical studies and results. Many other blogs and websites, as well as professional associations, provide information about stem cells and cell therapy news.Clinical relevant information about cell therapies – My New Therapy website is patient oriented and focuses on clinical data. As indicated, you can download the latest clinical relevance of a novelty to be in his vicinity in human patients tested, or to assess preferably, if being already a part of the reliable clinical study. This rule of thumb that has been tested in human patients can better assess needs for practical purposes or assistance, the clinical value of a product, service, technologyprocess or.