The FDA and Stem Cell therapy

The legitimate interest in stem cells and the promise of new therapies sometimes takes a back seat to overhype, false claims, and outright quackery- or at least a very conscientious effort to separate folks from their money. Enter the Food and Drug Administration (FDA.gov), whose main job it is to protect the public. A scheduled meeting at the FDA has now been delayed, but sometime this year a “conversation” will be held between many participants and stakeholders in the field. I suspect that “guidelines” will eventually be determined, and the public should take note; this is a conversation that should be held. A good resource for information is : http://www.ipscell.com/, no need to repeat it all here. We should all advocate safety,  proper product labelling, and a post treatment effort to determine efficacy.  This gets a bit sticky when the putative stem cell product is autologous (comes from YOU) and there is no drug company involved; but certainly we should at least know IF there are stem cells in the product. Not so easy. In cases where bone marrow aspirate is used, the injections may, in fact, have few if any stem cells …the abundance of such cells is low, and declines with age. Other sources of stem cells should have lot by lot quality control, using appropriate biomarkers, and cell counts.  Without better science, the task of separating a real therapeutic advance from a placebo effect becomes daunting.