The Muse in the Middle

Dr. Rand McClain on June 3, 2021

Stem cell replacement therapy— A gift from the gods or the end of our ethics?

When it comes to stem cell news, there seems to be no middle ground. It’s reported that either stem cell replacement therapy is a gift from the gods or it’s the end of our ethics as we know them. Very few news articles have taken the time to step away from the hype and answer some very basic questions. So, if you will, please allow me.

What’s in a Name?

Regenerative medicine focuses on regaining lost or impaired body function. Adult stem cells can replace cells that have died or just stopped working effectively. Athletes have found that they help to heal or prevent injuries. Research has also shown stem cells can help fight certain diseases and serve as an anti-aging treatment. And, of course, stem cell transplants have been used since 1957 to restore the immune system after chemotherapy for cancer and these treatments continue to be improved and used today. It’s all good stuff.

Part of the controversy surrounding stem cell replacement, pounced on by the media, is the idea that stem cells must be retrieved from human embryos or specifically the umbilical cord, which has raised ethical concerns. But the reality is that all approved therapies in the United States do NOT include cells harvested from fetal tissue and are either performed using adult stem cells or those collected from donated (and otherwise typically discarded) umbilical cords of successful healthy births. And yes, more investigation into adult stem cell use needs to be done, but the idea that medical researchers are looking to “frankenstein” the human body or scavenge for stem cells is hyperbole, to say the least. One impetus for stem cell treatments is the success observed using what one person already has an abundance of to give someone else a new lease on life, much like a transplant but much less invasive and more accessible. It’s a procedure that dates back to 1948 and was expanded in 1968 when the first adult bone marrow cells were used in clinical therapies for blood disease.

There are different kinds of adult stem cells, categorized differently depending upon their capability or potency, their use and their derivation (as well as by the branch of science or medicine that is doing the categorizing): three main types found in the blood and bone marrow called hematopoietic stem cells, mesenchymal stem cells, endothelial stem cells, but there are other types found throughout the body, and each of these has a predilection to replace a particular type of cell. One of the most versatile types of cells is called a Muse cell – a type of cell that resembles a stem cell that increase in number under conditions of considerable stress, and exist in the blood, bone marrow, and connective tissue of various organs. So, when an organ isn’t working properly, stem cells and Muse cells collected from a donor can be administered to a patient through an IV infusion, intramuscular or intraarticular injection to regenerate tissue and restore functionality. Some might call them a doctor’s muse for healing. Too much? 

Why is the FDA Being Cautious?

The FDA is in the middle of the debate over these new therapies. They are tasked with regulating regenerative medicine products to ensure that they are safe for patients. Just like any other type of drug or medical procedure, the FDA must be cautious because they have to protect the best interest of the patient. They demand strict testing and evidence to show that these treatments aren’t harmful. But sometimes oversight can be a slow process, and, while use of stem cells and even Muse cells have been proven safe and often efficacious in many other countries, the process of proving the efficacy and safety here in the United States has not been completed. Meanwhile, patients should be wary of unqualified doctors trying to take advantage by marketing therapies that have not yet been approved or for which they have not undergone proper training.

It’s important to be your own medical advocate and do your homework. Know what regenerative therapies have been approved and what products or services are undergoing legal clinical trials. Work in consultation with your physician, and don’t take any unnecessary risks. Seek advice as if you were undergoing any other medical procedure.

Options Available Now

So, what’s available now for those interested in stem cell therapies? First, you can ask your doctor if there is a trial in your area or a reputable clinic in another country. Look for studies that mention “IRB Approval” or are part of an “IND Study” since these are those that have FDA oversight and approval to be undertaken. Take advantage of websites that provide an overview of trials and clinics throughout the world.  One of the best sites is run by The International Society for Stem Cell Research. It provides links to a wide range of other resources too. Depending on your ailment, you could also try to work on the reverse by matching your issue with a potential stem cell treatment. 

Educate yourself about whether a given clinic or treatment has been the subject of lawsuits, controversy, or negative (and well researched) publicity. Some stem cell purveyors exaggerate claims, take shortcuts with their techniques, and engage in other practices that are morally dubious. Look for clinics run by individuals with strong science and medical credentials.  Ask your doctor about the validity of their methods and specific stem cell extraction and infusion approaches.  Beware of any clinic that is selling stem cells like a late-night TV pitchman hawking slicers-and-dicers.  

Then, set a budget and determine how much, if any, insurance is willing to cover. Currently, most insurance plans will only cover stem cells collected through bone marrow transplants. Be mindful that different methods have different associated costs. In many cases, liposuction is the most cost-effective option, and those stem cells can be expanded, offering more bang for the buck.

Finally, keep track of emerging treatment developments.  Stem cells represent a rapidly evolving field, not just scientifically but from a regulatory perspective.  Invariably, new and more effective treatments will emerge for a wide range of conditions. At the same time, stem cells will gain greater acceptance overall—while the media continues to play catch up.