Is FDA Caution in Approving Stem Cell Treatments Justified?

Stem Cells Therapies: Are they actually safe? Why is FDA approval being withheld?

As is the case with any investigational or approved treatment, consumers have the right to speak with their doctor to learn about the potential risks and benefits from being treated with a stem cell-based product. At Stem Cells Transplant Institute in Costa Rica we work with transparency and loyalty with our patients. We want our users to feel safe and well informed about the treatment they are acquiring. Do to the fact that many treatments are not approved yet in the United States, you may have some questions like: Why does the FDA have not approved these therapies yet? Is it something wrong? What is the real panorama?

In order to answer these questions, it is very important to understand what is the mission of FDA and what is the drug development process. First of all, is necessary to know that the time required to legally market any drug, even the simplest one you might know takes years of study and has to go trough many phases first. The requirements change according to the country laws and the kind of investigation that is being done. At this point is important to mention that nothing is actually going wrong so far with stem cells research, in the other hand, the results are very promising and every year more and investigations are being approved. The point here is that the therapies are a relative new medical trend, so it will still take years to actually have well established long term studies. Absolutely every drug you have used in your life, had this same problem at the very beginning of its development process.

The mission of FDA is to ensure that drugs marketed in USA are safe and effective. FDA conducts research in the areas of drug quality, safety, and effectiveness. In the specific case of United States there are 5 different phases that are part of the Drug development process: 1.Discovery and develpment: In this phase researchers discover and design a product, they do tests of molecular compounds to find possible beneficial effects and only a small number of compounds that look promising, continue for further study. Once the compound is identified, researchers conduct experiments to answer important questions like: How it is absorbed, distributed, metabolized and excreted. What are potential benefits, the side effects, the best dosage and the best way to give the drug? Etc 2. Preclinical Research: This phase is done before testing a drug in patients. Researchers must find out whether it has the potential to cause serious harm. The preclinical research can be done in vitro or in vivo. FDA requires researchers to use development regulations which set the minimum basic requirements for: study conduct, personnel, facilities, equipment, written protocols, operating procedures, study reports and others. Is this phase already approved by Stem Cells Investigations? Yes, phase 1 and 2 where positive for this research. 3.Clinical Research: This phase refers to studies, or trials, that are done in people. 4 and 5 FDA review and post-market Safety monitoring: If a drug developer has evidence from its early tests and preclinical and clinical research that a drug is safe and effective for its intended use, the company can file an application to market the drug, once FDA receives it, the review team decides if it is complete or not. If it is complete, the review team has 6 to 10 months to make a decision on whether to approve the drug or not.

So Far FDA has found the therapies secure. The truth is that even though clinical trials provide important information on a drug’s efficacy and safety, it is impossible to have complete information about the safety of a drug at the time of approval. Despite the rigorous steps in the process of drug development, limitations exist. Therefore, the true picture of a product’s safety actually evolves over the months and even years that make up a product’s lifetime in the marketplace. So far Stem Cells therapies are in clinical phase in the USA.

The first clinical trial approved in the U. S using stem cells was in 2009. Since then hundreds of clinical trials have been conducted globally. Nowadays the most important investigation centers in the world are doing research on Stem Cells. The most studied and accepted stem cells so far are the Induced pluripotent stem cells (IPS), which are generated by reprogramming adult cells that have already differentiated into a specific cell, such as a skin cell. After reprogramming, iPS cells are able to develop into any specialized cell type in the body. At Stem Cells transplant Institute in Costa Rica they use top technologies to extract IPS from your own fat and bone marrow. The therapies are legally approved in this country and the fact that they are obtained from your own body makes almost null the possibility of rejection.

In conclusion, are the therapies safe? Yes, the therapies have demonstrated to be safe so far although they are not legally approved yet in the United States, but it is impossible to have complete information about the safety of a drug until years of use, that´s why it is important to make decisions together with your doctor, who can advise you about the benefits, potential risks and the best therapy that is available for you.

At Stem Cells transplant Institute in Costa Rica you can find high-qualified professionals to help you answer your questions about Stem Cells therapies. The Institute counts with legally approved therapies and top technologies. Remember look for the correct place to make the correct decision! Good health decisions are not just about absolute answers, but about right questions.