The Multi-Million Dollar Business Of Unapproved Stem Cell Therapies

The Multi-Million Dollar Business Of Unapproved Stem Cell Therapies

by from Medelita | Monday, Jul 11, 2016

Adult stem cells, and controversial embryonic stem cells, have been at the center of major research efforts to cure diseases such as ALS, cancer, heart disease, and other chronic conditions. As of January 2016, there are 10 types of stem cell therapies around the world that have received approval. However, the number of treatment options in the United States far exceeds this number, with a recent study showing that some clinics are offering treatments for 30 or more diseases and/or injuries.  Before we delve into the nature of these previously undisclosed stem cell facilities, here is a brief background on stem cells:

  • Embryonic stem cells are those that come from four to six-day-old embryos, that are typically a result of repurposed IVF treatments at fertility clinics. Ethical implications come into play when other methods are used to specifically generate these cells.

  • These unspecialized cells are “pluripotent,” which means they are a master key of sorts, able to generate into any cell in the body.

  • Multipotent cells are specialized cells that can only generate into certain cells within a particular system or organ. Bone marrow cells fall into this category, and are also what are referred to as adult stem cells.

The survey investigated 570 clinics that advertise being able to cure dementia, hair loss, pulmonary diseases, immunological conditions, and more with stem cell applications. While researchers are actively working to develop new treatments, bone marrow transplants and umbilical cord therapies are the only two FDA approved methods, meaning the therapies offered at these clinics are unregulated.  

Stephanie Simek, Ph.D., Deputy Director of the FDA’s Office of Cellular, Tissue and Gene Therapies, stated, ”[Although] stem cells can come from many different sources and under the right conditions can give rise to many different cell types, there is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body.”

The main concern with these clinics is the high potential to scam individuals with harmful treatments, or to make false claims to those that in fact have incorrigible diseases. In recent years, scammers have made millions of dollars by using these corrupt methods. Those offering to cure diseases linked to children or the elderly, such as autism or Parkinson’s disease, are the most concerning to the FDA due to the fact that the patients themselves are often not the decision makers, leaving them at risk to receive a potentially adverse stem cell treatment.

Some clinics do have positive intentions, such as cosmetic surgery offices that simply use the fat cells from liposuction to harvest adult stem cells for other cosmetic procedures. Orthopedic and sports injuries were the most highly marketed treatments, with the clinics offering additional stem cell services to help repair joint and tissue damages.  

The FDA recognizes that there are still some benefits to easily accessible stem cell therapies, and hopes to announce stem cell advertising guidelines by the end of 2016.


Aptly named, Enclothed Cognition is the official Medelita blog for medical professionals interested in topics relevant to a discerning and inquisitive audience. Medelita was founded by a licensed clinician who felt strongly about the connection between focus, poise and appearance.