The FDA’s approval process is extensive and time-consuming, so it is currently a work in progress. However, that does not automatically mean stem cell therapy is unsafe or poorly researched—it just has not yet made its way into the official United States recommendations.
Despite not yet being included in official treatment guidelines, mesenchymal stromal cells are already considered safe for use in specific medical contexts. Numerous clinical trials and research studies have demonstrated their safety and potential efficacy for various conditions. Many countries and regions around the world, including Europe, have already recognized the safety and therapeutic potential of MSCs and have established regulatory pathways for their use.
In Serbia, as well as in many European countries, regenerative medicine is subject to strict regulations and oversight to ensure patient safety and treatment efficacy. Our clinic adheres to all applicable European and Serbian healthcare standards and regulations.