Regenerative medicine has taken some abrupt turns and changes in the last two decades, and ongoing research is just furthering the study and use of stem cells in the treatment of medical conditions and disorders. The most promising advances in regenerative medicine today have more to do with the research and clinical trials necessary for determining the effectiveness of stem cell therapies for different medical conditions.
Just this month, the FDA issued a publication and statement about stem cell research and clinical trials. Up to this point, stem cell therapy has been growing largely without regulation. Without regulation, many doctors are using stem cells in new ways that may or may not be effective. When doctors who are not regulated perform stem cell therapy on patients, they are putting themselves and the patients at risk for complications and legal negligence.
However, all of that is set to change in the coming months. The FDA has now announced that they will be regulating stem cell research and stem cell therapy. But what does this mean for the advancement of regenerative medicine?
The most important aspect about this coming regulation is that it paves the way for thorough and legal human clinical trials to determine exactly what stem cells can do and what they can treat. Thus far, clinical trials have been few and far between because the FDA has not had a hand in approving them. This is all set to change fairly quickly, as the FDA begins reviewing and approving human clinical trials in regenerative medicine.
Another key advancement that we will see in regenerative medicine with this new policy is that doctors offering stem cell treatments may be more limited in what they can do or say when it comes to stem cells. The FDA has yet to approve any stem cell therapy for any medical condition with the exception of bone marrow transplants for those with leukemia.