The use of human stem cells in research and treatment has been a flashpoint in discussion for decades, ever since the practice came into being. You’ll often hear questions like, “Is stem cell treatment FDA approved?” An alternate of the query is “Are stem cell treatments legal in the U.S.?”
Note that one question focuses on legality while the other is about “FDA approved” status. Those are completely different things because many thousands of procedures, drugs and other medical or food-related activities are allowed by law but are not necessarily “approved” by the FDA. The short answer to the question about whether stem cell treatments are FDA approved is no, but there are a couple of exceptions.
Also, when discussing stem cells, it’s essential to note that there are four different kinds of them and the FDA has little to say about the “approval” of any of them in research but plenty to say about whether they can be used in retail, for-profit therapies. The four kinds of stem cells are:
- Induced pluripotent
- Cord blood
Note that most clinics advertising “stem cell therapy” use adult stem cells and not any of the other kinds. In addition, for-profit therapy clinics use what are called “autologous” stem cells, meaning cells that are taken from the patient’s own body, not transplanted from one person into another.
One of the key exceptions to the illegality of offering stem cell treatments is that it is okay to offer services when the only stem cells used are adult autologous cells. Also, the cells cannot have been “expanded” or enhanced in any way before they are put back into the person’s body. Finally, for clinics to meet the legal threshold, any procedure done with adult autologous stem cells must be performed on the same day as the donation of the stem cells. There can be no holding of the sample for use later on.
As long as clinics meet those strict requirements, stem cell therapies are allowed by law. But keep in mind that none of the therapies are “approved” by the FDA. In any case, the FDA is not in the business of approving or disapproving of therapies. Their main function, as a U.S. government agency, is to protect public health. They achieve this mandate by overseeing the purity of drugs, foods, cosmetics and drugs.
Myths About Stem Cells
There aren’t many other realms of modern science that are as susceptible to myths as the field of stem cell treatments. Here are some of the most persistent myths about stem cells. You’ve probably heard them all, but have you heard the facts?
- Myth: All stem cells come from human embryos. Fact: This is the most frequent myth, perhaps because its been around so long and is based on a pure misstatement. The vast majority of all stem cell treatments use adult cells, umbilical cord blood. If you know of a treatment clinic in your city that advertises its ability to help patients with spine, joint, ligament or tendon pain, they’re almost certainly using autologous adult stem cells to do their work. In fact, because adult cells are so abundant in the human body, most researchers prefer to use them in studies. Treatment clinics use them because they’re easy to remove from just about anyone’s fat tissue.
- Myth: The only good stem cells for therapy are from bone marrow. Fact: In the everyday world of stem cell treatment, the best and most available source is human fat tissue. It’s in everyone’s body and is easy to remove for treatment purposes. Bone marrow stem cells are used in specific types of blood treatment and tend to be harder to remove because of where they’re located: in the center of bones.
- Myth: All forms of stem cell treatment and therapy are unsafe. Fact: It’s simply not true. As for autologous adult stem cell therapies, they are highly safe procedures because the client is receiving his or her own blood, not blood from a donor. You can’t infect yourself.
- Myth: All therapies involving stem cells are untested and unproven. Fact: The opposite is true, namely that most therapies using stem cells have been heavily tested and shown to bring good results. Especially for people who suffer from joint pain, defective knees, problems associated with lumbar discs and problematic shoulders, stem cell therapy has a long record of effective treatment results. That means not only increased function and range of motion but significant pain reduction as well.
- Myth: Stem cell treatments are exorbitantly expensive. Fact: Quite to the contrary, most clinic-based stem cell therapies and treatments are much less costly than the common alternative: surgery. Of course, prices for medical procedures differ from region to region, but the average price of routine surgery is typically more than 10 times that of stem cell treatment for the exact same condition.Further, the risks associated with major surgery are well known. Many cautious people avoid surgery for this very reason. On the other hand, the risks associated with stem cell therapies are nearly non-existent.
- Myth: Stem cell treatments are painful and take a long time. Fact: This myth is wrong on both counts. For some reason, many people associate stem cell therapy with bone marrow donation. In fact, when you undergo stem cell therapy, the most painful stem, if it’s painful at all, is the needle stick to draw the blood sample. Typically, the entire process takes less than half a day and clients can return home or work within hours.Compared to routine surgery, the pain factor involved with stem cell therapy is minimal, if there’s any pain at all. Some people hate needles, so you have to take that factor into account. However, the majority of stem cell treatment clients are surprised at how quick the procedure is and how painless it is.
What’s the Future of Stem Cell Treatment?
As science advances, it’s inevitable that there will be more diverse forms of treatment with human stem cells. Whether the FDA gets on board and expands its rules about what is and is not legal is another question. Unfortunately, much of what the FDA does falls into the category of politics. It’s usually unwise to make a decision about a particular kind of therapy or medical treatment based on whether it’s technically, currently legal.
It’s helpful to recall that many treatments that are fully legal began as experimental procedures that were not legally offered to the public but only took place in controlled research environments. The good news is that stem cell therapy continues to make rapid advances on several different fronts, primarily those related to joint pain and associated discomfort. Athletes have made good use of the treatment and were, in fact, among the first major wave of clients for the technique when it was still brand new. After that, word spread about the effectiveness of stem cell treatment as more and more people turned to it as an alternative to surgery and prescription medication.