
Please let me begin by saying that I believe stem cell therapy is going to change the future of health and medicine in our near future. I am excited about the potential for healing with stem cell therapy and have been following the trend for quite some time. I look forward to the future of being able to reverse many chronic degenerative conditions with this incredible therapy. However, at this point in the United States, with regards to stem cell therapy, we need to take a long hard look to understand the landscape of what is the legitimate use stem cells and what is hype.

Let’s begin with understanding what a stem cell is? A stem cell is an undifferentiated cell that has the ability to become many other types of cells. For example, if you have a degenerative knee joint, and stem cells were injected into your knee joint, they would give rise to the formation of new cartilage cells. If they were injected into a diseased liver they would give rise to new liver cells. The ability of a stem cell to become specific types of cells is what makes stem cells so appealing. The term used to describe this ability is pluripotent (from the word pluripotential) meaning it can become any type of cell within the human body.  Amazing right? But, it’s unfortunately not that straightforward.

What is the source of the stem cell and how viable are they once delivered to a patient?  This is where the controversy begins. Stem cells can come from embryo’s, amniotic fluid, cord blood, and placental tissue. They can also be derived from adipose tissue and bone marrow. There are different types of stem cells, depending on where they are derived or sourced. Some stem cells are not pluripotent,  they are multipotent, meaning they can become many different types of cells, but not any type of cell. A pluripotent hematopoietic stem cell (PHSC for short), is a stem cell that can give rise to all types of cells in the blood. A mesenchymal stem cell (MSC) is multipotent and gives rise to all cells of loose connective tissue, allowing it to form things like cartilage. An embryonic stem cell (ESC) is the only true pluripotent stem cell, meaning it can become any type of cell within the human body, of which there are over 220. It’s important to note that although you’ll notice the word pluripotent used in PHSC’s, they are only able to make all types of blood cells, not all types of cells within the human body.

Currently, the only FDA approved use of stem cells in the United States is that of PHSC’s when they are used to treat disorders involving the blood. The use of stem cells to treat any other condition is prohibited in this country.

So, how are doctors able to advertise stem cell treatment? The answer has to do with cell regulations and the pathways for FDA approval of donor tissues. There are two different types of registrations for stem cells, a 351 or a 361 registration. A 351 cell-drug designation is a long, complex and expensive process. In contrast, a 361 tissue registration requires about 45 minutes to fill out and submit. The big difference between the two is that a 351 has to do with the cells being alive and thereby considered a drug. With a 361 approval, you don’t need to prove that the cells are alive, you only have to make the claim that they are. When you see advertisements for stem cell injections in this country, they are using the 361 approval as a loophole to lead you to believe they are using live stem cells.

This is how companies and doctors are able to advertise that they are providing stem cell therapy. The problem is, the stem cells they are selling or using are dead! Sure they can tell you that their product is from cord blood, or amniotic fluid, or placental tissue and that it has live stem cells, but once these cells are harvested they must be processed, concentrated, freeze-dried and packaged. Then they are thawed and ready for use. The problem is, by this point in time, there are no viable, living stem cells. Even if they were alive, they would not be pluripotent.

There has been some evidence of cell regeneration with these treatments, but that has more to do with the remaining leftover growth factors, hyaluronic acid, and stem cell activators. There are currently other types of approved treatments such as Platelet Rich Plasma (PRP) injections or prolotherapy injections available. Both have shown to have positive effects on stimulating the growth of stem cells and cost much less than the current cord blood (dead) stem cell injections.

What other options are available? There are clinics that will offer to source the stem cells from your own adipose tissue or your own bone marrow. This may be a viable option, but still a gray area as far as the FDA is concerned. Their current position is that once the tissue is outside of the body it is considered a biologic tissue and a drug, and once anything is considered a drug it must go through the process of FDA approval. The only options left are to go outside of the United States, or opt for PRP or prolotherapy injections.

I am confident that things will change for the best as time moves on. One day I believe we will be able to receive safe and effective stem cell treatments that will have amazing results in treating a variety of conditions, thereby allowing us to live longer, more productive lives. For the time being, be wary of what is currently being offered and in my opinion, save your money. If you are facing a life-threatening disease or a debilitating condition and you are set on stem cell treatment, you’re only option is to look for a reputable doctor or clinic outside of the country.

For the time being, be cautious about spectacular claims of stem cell treatment in the United States. Unfortunately it is more hype than anything else.


health

Stem Cells: Should you believe the hype?

Become a subscriber today!