There are many types of Cellular Treatment, but is there a best form out there?
There are many types of stem cells being used in the Regenerative Industry. But how do these cells compare to bone marrow Mesenchymal Stem Cells? In this post I will break this down, and see what science is left behind.
What about the promise of retrieving MSCs from amniotic fluid?
Amniotic fluid is what surrounds the developing fetus in utero. It was thought to have promise for another readily available source of regenerative stem cells from what would be discarded during labor.
This too was exciting for a stretch, but independent research conducted by the Interventional Orthopedics Foundation (IOF) did not support the claims of these products. They had a hard time finding living MSCs in samples tested.
Some companies making these products are over-reaching then when marketing them as “Cellular Treatment”. Others more correctly state that even if there are no living cells, the dead cells could leave behind some amount of growth factors that could stimulate additional healing if combined with older MSCs taken from the patient. That may have some evidence to support the claim, but it would be far better to create those growth factors from the patient’s own blood. (Your platelet cells, taken from a simple blood draw from your arm, contain vast reservoirs of growth factors – and are far less expensive to source than manufactured growth factor products).
Those of us in the Integrative Orthopedics field continue to be hopeful that someday in the future we will have products that are backed by science and can be used to augment the response of our current treatments. Or, alternatively they can be used in patients from which we are not able to use their cells for medical reasons.
Manufactured products certainly may contain some useful growth factors that can stimulate healing and contribute possibly to the positive outcome some patients experience with the treatments, but they are not true stem cell procedures.
If companies simply marketed them truthfully for what they are – growth factors – and did not charge thousands of dollars for a couple of milliliters of the stuff, then it may have some potential to be another tool we can use to help more people through Regenerative procedures.
Bottom line: Data continues to support that companies manufacturing placental, umbilical, and amniotic sources of “stem cells” are misrepresenting the products as stem cell products when they actually contain very few live cells.
What About Adipose (Fat) Stem Cells?
As far back as the first World War it was found that fat had some innate potential to help wounds heal faster in injured soldiers.
Adipose grafts were also being used successfully for decades in plastic surgery and reconstructive applications.
Let us now chew the fat a little more to see if this cell source is a viable stem cell treatment option for Orthopedic applications.
There is at least one company (Lipogems) marketing fairly aggressively that their device is FDA-approved (since 2014) and has an indication to treat conditions including knee osteoarthritis.
The procedure involves taking some fat and breaking it down mechanically in a device.
Here is an actual snippet of the FDA approval:
“The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system.
The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired.”
The indication talks much about surgical applications but very little about producing a viable stem cell product, nor specific application in a non-surgical setting for Orthopedic conditions.
Reviewing their website, they are not marketed it as a stem cell procedure but rather state:
“Lipogems is an innovative therapy option that employs a precisely engineered device to create an injectable micro-fragmented fat tissue made from your own adipose tissue reserves that can be used to repair injured or damaged tissue and provide cushioning and support as your body heals.”
Despite the fact that they are not marketing it as Cellular Treatment, that hasn’t kept physicians from making the leap on their own.
The “selling point” is that it is a simple and far less invasive procedure than a bone marrow aspiration. It certainly is. I can and have performed this procedure in less than 30 minutes, and patients have little discomfort if any harvesting the fat cells.
The problem is that this is not the highest level of Cellular Treatment!
This, or any other device on the market like it, is simply a device to create a fat graft, from what we term a lipoaspirate – a mini-liposuction procedure. The fat graft material can be very useful in reconstructive procedures where defects are being filled. Basically, it can be used as a “biological filler” and very commonly is used in Cosmetic Plastic Surgery.
This has been determined to be quite useful for filling in large tendon, ligament, or other soft tissue defects. Essentially you can think about it as a soil that we can spread into larger holes in the tissue to “level it out” and then plant high-quality bone marrow MSCs in to stimulate healing. This is why you will find some Integrative Orthopedics clinics using fat cells possibly as a component of their stem cell procedures.
The Interventional Orthopedics Foundation (IOF) tested the Lipogems device to determine if there are any viable MSCs released from the adipose. When mechanically broken down by this process they did in fact find that some viable stem cells, but again far less than what is recovered in a typical bone marrow aspiration.
With further study, scientists determined that there is a specific fraction of your fat cells that are actually legit mesenchymal stem cells, termed the stromal vascular fraction (SVF).
The problem is that you cannot maximally extract or separate the SVF component through a mechanical process alone. The reason is that the SVF cells are bound tightly by collagen, a connective tissue, that holds the adipose cells together, kind of like a net.
In order to break down and remove all of collagen to fully release all of the SVF MSCs, it requires the use of enzymes. And this is where the FDA states that this is going beyond the regulations of acceptable minimal manipulation of cells and tissue.
This has not stopped clinics from doing this procedure.
Since 2013, the FDA has been cracking down on clinics known to be using enzymatic breakdown of adipose in this way. In fact, just in May 2018 the US Department of Justice, on behalf of the FDA, filed another major lawsuit against once such company.
This is a true point of contention between Integrative Orthopedics specialists that are working to advance the field, and the FDA that continues to regulate the use of how you the patient can decide to use your own cells.
The FDA is doing this first because they have a primary responsibility to vet the safety of the procedure before widespread use. That is fine.
However, other countries have been safely using this technology for many years, and it has helped countless patients, at a fraction of the cost of standard treatments such as joint or spine surgery.
Those of us who know the potential, agree that is a simpler and less invasive procedure, and holds great promise, especially for the older population who may produce fewer bone marrow stem cells.
If it is being used in other countries with great success – wouldn’t it be nice if we were freed up to harness the full potential of this form of Cellular Treatment??
For now, the current FDA regulations are very clear on how adipose graft stem cells can be used for Orthopedic applications.
• Adipose (fat) grafts can be used.
• Mesenchymal stem cells (MSCs) can be obtained from adipose lipoaspirates
• Using enzymes to break down the adipose graft is currently not allowed by the FDA.
• The numbers of cells will be far less than what can be obtained from a bone marrow aspirate unless enzymes can be used.
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