| The process of finding and developing new drugs is | | | | application. Being in the clinical stage of development |
| long and costly. It takes years and millions of dollars | | | | is meaningful for practical purposes, although only |
| for one single new drug to be developed from the | | | | few products will turn to be safe and effective, and |
| stage in which a candidate molecule was identified to | | | | approved for clinical use. The clinical phase of the |
| the ultimate stage of regulatory approval for | | | | development may take about 2 to 5 years, and |
| marketing. The new era of stem cells and | | | | sometimes longer. |
| regenerative medicine does not shorten this process. | | | | In some countries, it is legal and possible to offer cell |
| On the contrary, it presents new challenges in the | | | | based treatments even before the full scale clinical |
| road through translation into approved therapy. The | | | | studies were completed. Clinics and hospitals in such |
| challenges are due to the completely new and | | | | countries are treating patients for life threatening and |
| different structure of the final product. Patients are | | | | chronic diseases before thorough testing and |
| treated with living cells instead of active molecules. | | | | approval by regulatory agencies in the US, Europe or |
| The road to develop new cell based therapy is not | | | | other countries. Most of these clinics do not conduct |
| less long, complicated or costly than the road to | | | | or publish systematic clinical trials, but they usually |
| develop conventional drugs. | | | | provide information on the technologies and |
| The amount of information in the media, both | | | | therapeutic approaches used. Can this be regarded as |
| professional and popular, is huge. Nonetheless, most | | | | "tested in human patients"? The answer is no, but it |
| of it, although interesting and supportive for further | | | | is up to the patient to decide whether he would like |
| development, is not applicable for present patient's | | | | to take the risk with all its implications, rather than |
| needs. If we want to evaluate the current potential | | | | wait for the therapy to be approved. |
| of a new therapy, the most important parameter is | | | | Most reliable information on ongoing clinical studies is |
| how close it is to clinical utilization. Practically, we want | | | | found in the FDA (US Food and Drug Administration) |
| to know if the therapy is used already to treat | | | | database - Clinicaltrials.gov. Although US based, most |
| diseases in human beings. Such treatment can be | | | | clinical studies from many other countries as well are |
| either experimental in its early stages, or ultimately, | | | | published in this comprehensive website which also |
| approved by regulatory authorities and provided by | | | | includes effective internal search option. However, |
| companies, clinics and hospitals. | | | | early pilot and phase I studies are usually not listed |
| Let us look at the various stages of development | | | | there. Results on clinical studies can be found in the |
| and thus be able to identify the most relevant ones | | | | well known scientific literature data base website, the |
| according to this simple principle. Research is | | | | US NIH (National Institute of Health) PubMed |
| conducted on the molecular and cellular levels, as well | | | | -Ncbi.nlm.nih.gov. Here again, the relevant clinical data |
| as in experimental animal models. Such research | | | | will be difficult to extract from the plethora of |
| generates large amount of data, and set the basis | | | | scientific information, and it is mostly used by |
| for identifying new modules of therapies. Once a | | | | professional scientists. Large medical centers will also |
| promising candidate is identified, the process of drug | | | | provide updated information on scientific |
| or cell based therapy starts. It needs full | | | | achievements, along with clinical trials and results. |
| characterization, understanding mechanism of activity, | | | | Many other blogs and websites, as well as |
| optimization of large scale production, thorough | | | | professional organizations, provide information on |
| analysis of safety profile, establishing quality control | | | | stem and cell therapy news. For clinical relevant |
| tests and more. The first stage is a general or | | | | information on cell therapies - My New Therapy |
| theoretical research, while the second is called | | | | website is patient oriented and focuses on clinical |
| pre-clinical development. Once this stage is | | | | data. As suggested, you can evaluate the current |
| accomplished, the product is ready for clinical studies, | | | | clinical relevance of a piece of news according to its |
| following the submission and approval by regulatory | | | | proximity to being tested in human patients, or |
| body. This third stage is termed clinical development. | | | | preferably, if being already a part of reliable clinical |
| The clinical studies are conducted at three stages and | | | | study. This rule of thumb, being tested in human |
| if successful, approval for marketing is obtained. A | | | | patients, can help to better judge for practical |
| product or process which is presently being tested in | | | | purposes or needs, the clinical value of a product, |
| clinical studies, can be better evaluated for its current | | | | service, technology or process. |