FDA revises the regulations of stem cell therapies and regenerative medicine
The regenerative medicine which implies the extensive use of stem cells has become one of the most far-reaching fields of medicine and science. These innovative technologies have the potential to significantly improve current treatment methods as well as find brand-new treatments for some incurable diseases and permanent injuries. More recent attention has focused on understanding the mechanisms underlying the processes of tissue damage and regeneration. These researches have led to considerable progress in adult stem cell biology. There is no doubt that for the time being medicine is at a turning point. The scientists should put efforts in finding the possible ways of implication of cell technology in treating a wide range of conditions such as cancer, Parkinson’s disease, diabetes mellitus and many others.
However, although cell therapies hold much promise, the novelty of these techniques is associated with uncertainty as this field develops. Unfortunately, there are bad actors who use this uncertainty and deceive patients offering them unproven, sometimes even dangerous medical products. They assure patients of the effectiveness of their products and encourage their optimism that lead to the fact that they successfully sell their products at very high prices. This puts the entire field of stem cells therapy at risk. It would be much harder to improve existing reliably and carefully developed products provided unscrupulous corrupted actors are still able to promote unproven, illegal, ineffective and even dangerous treatments.
In the meantime, FDA intention is to make sure that the existing framework is well defined, with bright lines separating new medical products which are subject to the FDA’s regulation from those therapies that were individually developed by surgeons for their patients. The latter products are not subject to FDA’s regulation.
The FDA is aiming at the creation of an efficient and least burdensome framework that will allow the new products to remain compliant with the law and won’t become a barrier to beneficial new innovations. The FDA plans to implement new regulations this autumn.