Orthobiologics, sometimes misleadingly called stem cell or regenerative medicine injections, is the generally accepted term for injecting one’s own body materials (such as blood or fat) at a site of injury to promote a healing response.
In our current medical climate, there is a lot of misinformation and disinformation surrounding the body’s capacity to heal itself with experimental treatments. This article is intended to provide an overview of orthobiologic treatments, as well as education on false claims and fraudulent terminology.
There are many clinics around the country advertising regenerative medicine and stem cell injections. This is why the term stem cell injections is misleading. In the United States, any tissue that is harvested, such as blood, bone marrow or adipose, with the intent of injecting back into the body must be harvested, centrifuged and injected all in the same day (except in the case of stem cell transplants). Therefore providers are not allowed to harvest bone marrow or adipose tissue, separate and culture stem cells (which takes many days or weeks), and then re-inject them at a much higher concentration.
Using Our Own Bodies to Heal Our Own Bodies
In orthopedics, our experience with orthobiologic treatments has been very exciting. We have provided injections either of platelet-rich plasma (PRP) from the patient’s own blood, or concentrated adipose (fat) combined with PRP, to hundreds of joints, tendons, ligaments and soft tissue sites. More than 360 research studies about these types of treatments have been published, with nearly all of them showing improvement in their subjects. However, there is little that has been published in a randomized controlled trial fashion to prove that these treatments are superior to standard of care, such as cortisone injections.
Dr. Hoff receiving a concentrated adipose and PRP injection into his knee
While the gold standard for a severely arthritic joint is still a joint replacement, a number of our patients that were recommended for total joint replacement have undergone injections of concentrated adipose and PRP to joints and have done very well. Many of them have improved to the point of having little to no pain and are able to return to most, if not all, of their daily living and sports activities.
The patient population we have treated with OrthoBiologics ranges from 16 to 93 years old. Knees have been the most common application, with shoulders and hips nearly as prevalent, and many other sites such as… have also been successfully treated.
As the procedure uses the body’s own materials with a simple mini-liposuction for the fat harvest and small blood draw for the PRP, the complication rate is extremely low and there is little concern for negative side effects like with, synthetic substances.
Unfortunately, at the time of this writing, there are no insurances that cover this type of procedure and the cost can vary from practice to practice. We have made every attempt to make this procedure affordable for the general population, and we continue to advocate insurance companies for cost effectiveness and patient benefit.
It is my hope that in the next few years we will be able to recruit for and publish our own randomized controlled trial to further assist with this next evolution of OrthoBiologics medicine. Such studies will be necessary for these procedures to eventually achieve insurance approval.
If you’re dealing with joint or muscle pain and would like to find out if you are a candidate for OrthoBiologics treatment, talk to a provider you know you can trust. Call EmergeOrtho for a consultation.
A Little History
Beginning in 2008, a new and promising line of treatments for multiple physical maladies was first published. As the term OrthoBiologics was not yet coined, many of the authors of these original research papers used the appropriate terminology with whole blood, platelet rich plasma, bone marrow, concentrated bone marrow, adipose, and concentrated adipose injections.
The differences evolved when terminology, such as stem cell and regenerative, started being used. Currently in the United States, injections of “stem cells” are not available for any orthopedic applications. The guidelines from the FDA (Food and Drug Administration) limit our ability to manipulate any and all human cells to what would be classified as “minimal manipulation.”
What this means is that in the United States, as opposed to in Europe where human tissue manipulation is less heavily regulated, we are unable to harvest human tissue and grow or culture stem cells from that tissue. Although there are many providers and clinics who advertise “stem cell injections,” these claims are misleading and significantly exaggerated.
Bone marrow and adipose tissue do contain both hematopoietic and mesenchymal stem cells, the stem cells that differentiate into the majority of the tissues in the body. However, they also contain many other components and even with the concentration of the bone marrow or adipose tissue, the majority of the product is neither a hematopoed or mesenchymal stem cell.
In addition, it is quite dangerous to receive live, active cells from an individual other than one’s self without appropriate cleaning, matching and typically destruction of immune cells. This is the reason blood donors have to be cross-matched and typically blood is irradiated prior to infusing in the recipient.
So, what does this mean for you? It is important know that providers who claim to regenerate tissues with stem cells are fraudulent. The FDA has worked hard to crack down on these types of clinics. Unfortunately, it is easy potentially/likely? to open a fraudulent clinic and often very hard for the government to shut one down.
Despite the growing use and popularity, and numerous published studies; most insurance companies do not cover orthobiologics techniques. These companies deem this use as “experimental” and not approved. Discuss this with your provider for more information.