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Why Is Stem Cell Therapy Still Illegal?

In 2018, actor Mel Gibson and Dr. Neil Riordan appeared on the popular podcast series The Joe Rogan Experience to talk about stem cell treatment.

Gibson explained how his father, a 92-year-old man with serious age-related problems, dramatically improved after getting stem cell treatment at Dr. Riordan’s renown Stem Cell Institute in Panama. Rogan then started questioning the Doctor – a pioneer and an expert in stem cell research –, and conversations about the benefits of stem cell treatment (Rogan himself had had his shoulder injected) and its illegality in the United States ensued.


Although Gibson brought a scientist along with him to back up any false or misleading statements he may have erroneously made – thus setting a more intelligent example –, publicity about “celebrities from Hollywood going to remote islands to have some intravenous stem cell injection” is becoming an issue, when it comes to acquiring such relevant, accurate, complex information.


To begin with, one has to understand what stem cells are. Any research will give you the same result, the simple statement that: stem cells are ‘unique’ cells – found in our body – which are able to reproduce into any type cell (blood cells, brain cells, bone cells, fat cells, etc…). What makes them unique is the fact that no “other cell in the body has the natural ability to generate new cell types”. Indeed, they can either multiply into themselves, or specialize into any other cell type: controlling this latter process is just what stem cell therapy is about.

Stem cells may be found in embryos (embryonic stem cells), in adults (adult stem cells) – in “adult tissues, such as bone marrow or fat” – and in the amniotic fluid and umbilical cord blood (perinatal stem cells). Researchers find that embryonic and perinatal stem cells are much more versatile than adult ones, in specializing into any other cell type in the body. However, genetic reprogramming has allowed scientists to alter the genes in adult cells thus making them act as embryonic cells.


As we move from what is known as ‘reactive medicine’ (reacting to injuries and health problems, only being able to “prevent further damage”) towards a ‘regenerative medicine’, where we are actually able to repair those injuries and health problems, stem cell therapy seems to be of key importance. Sharks, for instance, are able to regrow their teeth and live hundreds of years precisely because of the abundance of stem cells in their bodies.

Stem cells can be grown in a lab, “manipulated to specialize into specific types of cells”, and then implanted, injected directly into a localized area in a person’s body: into the heart muscle, for example, if a person suffers from heart disease. (The now healthy heart cells, which were originally stem cells, would reproduce and effectively repair the heart muscle) Gibson himself stated that, after treatment, his almost-a-hundred-year-old father “started walking again… His kidneys were good, his heart

[…] healed, and his cognitive powers improved, his eyesight improved…” All this, owing to a strong injection of stem cells.

(Here is a link to sensitive footage of a Bone Marrow Prolotherapy for treatment of the knee, hip and ankle – to show you how Stem Cell Therapy actually works)


Does it sound too good to be true? Yet, if such a treatment does exist and is indeed possible, why is it still illegal in most parts of the world?


Before we answer this question, we should get an idea of what the global map looks like, when it comes to stem cell research and therapy. The United States are at the top of the list; South Korea, India, Iran, Canada, Australia and China are some of the countries following behind, though not at a close range – since the number of clinical trials is way higher in North America.


In spite of this, the U.S. Food and Drug Administration (FDA) still considers stem cell treatments “illegal and potentially harmful”, and warns patients against being fooled by clinics. The FDA regulation states that manufactured products (stem cells in this instance) require approval by way of a very thorough review process; however, it is often the case that clinics advertise their treatments as being FDA-approved when they are not. The potential risks that patients in unstable or complex conditions might incur are high: some unsuccessful cases even recorded the growth of a tumor (as a result of stem cell multiplication) and the loss of sight in one eye (as a result of an eye injection).

So far, only treatment with “blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood” has been approved in the USA.


As a result of not being widely allowed and legalized, stem cell treatment is incredibly expensive too. In fact, it may cost anything between 1,000 and 100,000 dollars, depending on: the type of treatment, the type of stem cells administered, and the clinic’s geographical location.


As medicine moves into “a new way of thinking”, stem cells are at the centre of the debate. Although it may be argued that the FDA’s regulations are particularly strict, the reasons why a country would diligently make sure that all of its medical products and practices are safe are easy to be grasped. As a human race, we strive for improvement as much as we tend towards evolution. It is in our nature. Finding new ways – better ways – to survive and behave is just what our modern life is about: we just need to make sure that, in doing so, we do not deceive each other – as we often have –, thus compromising the health of many for the benefits of a few.


Written by Edoardo Cippitelli


Edoardo Cippitelli is a columnist at DecipherGrey.