Ep. 11: The Controversy Over Stem Cells

Hey everyone, Dr. Jay Bowen here, and welcome back to the NJ Regenerative channel! Over the last few weeks, my team and I have been shedding some light on various regenerative procedures. Today, we’re diving into one of the most talked-about topics in regenerative medicine: stem cells. They’ve been labeled as everything from a miracle cure to a controversial therapy. But as always, we’re going to break it down and give you the good, the bad, and the truth about stem cells in medicine today. Let’s get started!  

What is a stem cell? So what exactly are stem cells? Stem cells are the body’s raw materials—essentially, the building blocks of life. They have the unique ability to develop into many different cell types, from muscle cells to brain cells, depending on what the body needs. What makes them so powerful is that they can either renew themselves by dividing or specialize into cells that have a specific function. For example, if there’s damage to your tissue—like in a knee joint after an injury—stem cells have the potential to step in and transform into the type of cell needed to repair that tissue. They play a crucial role in growth, healing, and even maintaining overall health.

Now, let’s talk about the FDA’s role in stem cell therapies, because this is an area that’s often misunderstood. The FDA, or the Food and Drug Administration, has a role to evaluate disease transmission with treatment and is responsible for ensuring that medications in the U.S. are both safe and effective.  In one case, the FDA argued and the court agreed stem cells were drugs. If (and this is a big IF) stem cells are drugs or medications then FDA DOES have the jurisdiction to regulate them. 

Remember, I am not a lawyer and do not play one on TV.  This is just a general overview.  However, in the most recent court case, the judge determined that one’s body CANNOT be a drug and FDA has no role in regulation. This may be appealed by the government.  The FDA has no scope in the “practice of medicine.” You may think this is scary that no one regulates these treatments, but this is incorrect. Each State has a Board of Medical Examiners that can monitor these treatments. The use of stem cells is regulated the same way a conventional surgery is regulated. In general, the FDA considers 3 factors in regards to stem cell therapies:

First, is minimal manipulation: this means that the cells that are taken from your body cannot be grown in a lab, etc.  They can be cleaned with salt water or resized through a filter to make injection easier but they must remain in their most natural form.

Second, the cells must be autologous: meaning, the cells that are used for your therapy must come from YOU and not another source.  This mitigates the concern for disease transmission. 

Third, homologous: This can have two potential meanings: the cells that are used must be of a similar structure or function as what already exists in your body. For example: you don’t find placental cells in your knee.  But you DO have a fat pad existing in your knee naturally; therefore we can use fat cells for a stem cell therapy in that particular area of the body.

Fourth, no additions or mixtures. This means that your cells cannot be mixed with another substance or drug to create an entirely new product. To be regulatory compliant at NJRI, we focus on platelet rich plasma or PRP, bone marrow or BMAC, and adipose or MFAT, which were discussed in prior videos.  These are minimally manipulated cells that are taken from your own body. If you want to learn more about these treatments, please check out the videos.  We can also take extra time during an MFAT treatment and obtain additional fat.  This fat can be sent off for storage and used at a later date. Currently, the only regulatory compliant method to receive these cultured expanded stem cells for treatment of orthopedic issues would be through the Right to Try Act, so you do not need to travel outside the country with large cost and many unknowns.  If you are interested in the storage of your cells, give my office a call to set up a consultation and I would love a chance to discuss this in greater detail as it relates to your situation.

One of the challenges we face is that not all clinics follow these guidelines or the regulations. There are some places that offer unregulated stem cell therapies that haven’t been properly tested, which can lead to false claims and, unfortunately, real risks for patients. Additionally, many clinics offer perinatal or umbilical tissues that have a risk of disease transmission. Some may claim that the perinatal tissue was treated to limit the risk of disease but in doing so, this may have ALSO killed any stem cells that could have been potentially present.  I’ll get more into this when I talk about the bad of stem cells in part 2 of this video. This is why it’s so important to work with reputable clinics, like New Jersey Regenerative Institute, that adhere to FDA guidelines and focus on evidence-based treatments

Stem Cell History

Alright, now let’s take a step back and look at how stem cells became a part of modern medicine. The concept of stem cells might seem cutting-edge, but did you know that the history goes back well over a century? Let’s dive into it. The first clues about stem cells came in the late 1800s. Scientists were already starting to wonder how cells in the body could differentiate—meaning, how a single cell could evolve into many different types of specialized cells. It wasn’t until the early 1900s that researchers began to seriously explore the concept of ‘stem cells’ as those early, undifferentiated cells that could give rise to other types.

Fast forward to 1908, and a Russian scientist named Alexander Maksimov proposed the idea of ‘stem cells’ as the foundation of blood formation, laying the groundwork for what we now know as hematopoietic stem cells—those are the ones that develop into all the different types of blood cells.

The next big leap happened in the 1950s and 60s. Researchers began understanding how stem cells could be used in medicine, specifically for treating blood-related conditions. In 1956, Dr. E. Donnall Thomas performed the first successful bone marrow transplant—a huge milestone that relied on stem cells. This procedure would later revolutionize the treatment of leukemia and other blood disorders.

In the following decades, stem cell research continued to focus on blood and bone marrow. The discovery that bone marrow contains hematopoietic stem cells, capable of producing blood cells, became the basis for many life saving therapies we use today. If you want to learn more about the power of bone marrow, check out my recent video on bone marrow aspirate concentrate, or BMAC for short. Click here.

By the 1980s and 90s, scientists began exploring other types of stem cells. One major breakthrough was the discovery of neural stem cells, which opened the door to exploring treatments for neurological conditions like Parkinson’s and spinal cord injuries.

But the biggest game-changer came in 1998, when Dr. James Thomson at the University of Wisconsin isolated the first human embryonic stem cells. This breakthrough sparked a wave of research into how we could potentially use these cells to regenerate damaged tissues, cure chronic diseases, and even slow aging. However, it also triggered ethical debates that still influence stem cell research policies today.

While embryonic stem cells offered exciting possibilities, the ethical controversies surrounding their use pushed researchers to look for alternatives. This is where adult stem cells took center stage. These are the cells we find in our own bodies—in fat tissue, bone marrow, and even blood—and they offer many of the same regenerative possibilities without the same ethical concerns.

Then, in 2006, Dr. Shinya Yamanaka from Japan made a breakthrough discovery with induced pluripotent stem cells, or iPSCs. These are regular cells, like skin or blood cells, that scientists can ‘reprogram’ to behave like embryonic stem cells. Yamanaka’s discovery earned him a Nobel Prize and opened up even more possibilities for regenerative medicine without the ethical hurdles.

Today, stem cells are being used to treat everything from orthopedic injuries, like we deal with here at NJRI, to heart disease. The focus has shifted to adult stem cells and the use of iPSCs, which are now being researched for conditions like diabetes, spinal cord injuries, and neurodegenerative diseases. 

While we’ve made incredible strides in understanding and using stem cells, we’re still in the early chapters of their story. Ongoing research continues to explore how we can better harness the power of stem cells to treat a wider range of conditions, and as science evolves, so too does the potential of these amazing cells. This is where our partner organization, DataBiologics is leading the way in stem cell research. Stay tuned for a live YouTube video with DataBiologics CEO Leah Braddel where she will discuss the company’s role in stem cell research. 

So, there you have it—a journey from the early 1900s to the cutting-edge research happening today. Stem cells have come a long way, and as science continues to evolve, their potential to revolutionize medicine is truly exciting. Stay tuned as we explore more about how these cells are being used in regenerative treatments in our video NEXT MONDAY. While today looked a bit different than the other videos in this series, I wanted to be sure to give plenty of background on stem cells before I gave you the good, the bad, and the ugly. Come back to our page next Monday for a few hot takes on stem cells!

That’s all for today folks! Be sure to tune in next week as I get into the nitty gritty of the good, the bad, and the truth of stem cells. With such a controversial topic, there’s plenty to discuss. Please leave a comment below or on any of our social media platforms telling us what you’d like me to address in my next video on stem cells. While we’re on the subject of socials, be sure to follow us! We are on TikTok, X, Instagram, and Facebook. Of course, our main home is here on YouTube. If you haven’t already and you’ve made it this far, be sure to smash that like button and subscribe HERE (point to top right!!!!). 

With the holidays approaching fast, now is the perfect time to come in and treat those nagging aches and pains so you can fully enjoy the most wonderful time of the year. My team and I here at NJRI would be honored to treat you. Give our office a call so we can get you on the schedule and unleash your intrinsic ability to heal. That’s what we do here! Alright, that’s all for me. See you all next week here on the NJRI channel.