Ethical Use of Stem Cell and Regenerative Medical Therapy
The interest in Stem Cell Therapy has exploded in recent years. Stories in the news about celebrities and elite athletes reporting incredible benefits from treatments with Stem Cells has captured the imagination of ordinary people wondering if this new treatment can help them with various conditions for which mainstream medicine offers no real hope.
It certainly is an exciting time for doctors and scientists as we race to find new ways to help people heal their own bodies using biological and regenerative therapies that have been found to be surprisingly effective and with very little risk of serious side effects. Unfortunately, like all great things, there is a dark side to the stem cell revolution and consumers need to be aware.
First of all, what we are calling “stem cells” may not technically be stem cells. Stem cells are characterized by their ability to replicate themselves and then eventually differentiate into different type of cells. An early embryonic cell that has divided a few times to create a cluster of immature cells can be considered true stem cells because they can, in fact, turn into any organ in the body. The cells with these qualities are considered to be pluripotent. As the embryo matures, groups of cells start to differentiate along different cell lines. Some of the cells will start to tend towards turning into blood tissue while others will turn into nervous tissue and others will turn into connective tissue such as skin, cartilage and bone. Once the cells have started towards a pathway of a specific type of tissue, they still have the ability to differentiate into multiple different tissue types but they are more committed to cell types within their cell line. These cells are considered multipotent. The debate about whether these partially differentiated cells can still be called “stem Cells” is becoming very heated and has attracted the attention of the FDA.
In the United States, the FDA is responsible for regulating the safety of food and drugs. Although cellular therapy is technically just a surgical transplantation of tissue, any product that is sold to the public with claims to cure diagnose or treat a medical condition can potentially be considered a drug. The FDA is even looking at the processing of your own tissue to be considered as manufacturing a drug if it involves more than minimal manipulation. With this in mind, the FDA is currently very interested in what we are calling these cells and what kind of claims we are making about these biological therapies. So let’s take a look at some of the different therapies that are in the arena of “Stem Cell” treatments.
Emryonic cells (true stem cells) are not what we are referring to when we talk about stem cell therapy. The cells that you would receive at any legitimate clinic in the United States come from adult tissue. Even the umbilical cord and amniotic cells are considered adult tissue. Some of the opposition to stem cell therapy stems from the misconception that aborted fetuses are the source of the cells. Using fetal cells is illegal in the United States and is not generally practiced anywhere in the world because these cells are too immature to be useful therapeutically. When truly pluripotent cells are implanted, they tend to not respond very well to signals from nearby cells directing them to differentiate into the needed tissue. There have been reports of bizarre tumors containing teeth and hair growing in the spinal cord when embryonic cells were used. These cells also have a high risk of becoming cancerous. For these and other ethical reasons, use of aborted fetal tissue for stem cell treatments is not a realistic concern. Adult cells are much safer and more effective.
There are many different sources of adult cells that are commonly being called stem cells. These cells are either harvested autologously from the same patient such as from the bone marrow or fat, or they are donated from other people such as umbilical cord and amniotic membrane tissue. Stem cells can also be created in a lab by taking adult cells and inducing them to revert into immature cells that have the ability to later differentiate.
Because we do not have a very effective way to identify specific cells that are harvested as stem cells in a clinical setting, we tend to estimate by counting the number of nucleated cells in a specimen and extrapolate the percentage of those cells that we believe are stem cells. This is where we run into the potential for some very confusing and misleading information being given to the patients.
Lets begin with what is not a stem cell treatment. PRP, Platelet Rich Plasma is a biological treatment that is believed to work by signaling your own body’s stem cells to migrate towards a targeted area. PRP is acquired by taking a sample of blood. You may find a stray stem cell in the mix, but there are no stem cells in PRP.
Sterilized amniotic membrane tissue is produced by taking amniotic membrane, dehydrating it and irradiating it to kill all living cells and viruses. The tissue is then powderized and resuspended into saline. This product does not need to be cryopreserved or even refrigerated. There are no live cells in this type of product, but the signaling growth factors in the product are very potent and just like PRP, these growth factors can help direct your own stem cells. The signal from this type of product is thought to be stronger than from PRP. Some people are marketing PRP and sterilized amniotic tissue as “stem cells.” This is misleading and fraudulent advertizing.
Cryo-preserved amniotic and umbilical cord tissue do have live cells. These cells are typically harvested from donors who have been carefully screened just like a blood donor. The tissue is harvested at the time of a scheduled c-section. In order to protect the integrity of the donor pool, donors have to be volunteers and are not allowed to be paid in the United States.
The actual number of live cells present in these specimen are debatable. The laboratory processing the tissue will count the nucleated cells that can potentially be stem cells. They can do this manually with a microscope, they can do it using a flow spectrometer and they can culture the cells and count the number of colony forming units (CFU). The later is the most accurate way to determine the percentage of cells that are in the specimen that have qualities of stem cells. Because there are so many subjective variables involved in counting stem cells, these type of analysis should be performed by an independent laboratory to avoid conflict of interest.
Transplanted placental tissue seems to have an immune evasive quality that allows the transplant to occur without a host vs graft reaction as might be expected. This is believed to be because the cells are so immature that the host’s immune system does not immediately recognize the implanted cells a foreign. The host's body eventually finds these cells and eliminates them but not before the implanted cells signal your own cells to start the regenerative cascade.
When a stem cell vendor gives you a number, the information really needs to be taken with a grain of salt. They might tell you that in 1cc of product there are 65 million cells. Or they may tell you that there are 2.6million stem cells in the same sample. These numbers are estimates. The 65 million cells may be referring to the total number of potential cells and the 2.6million may be referring to the extrapolated number of possible stem cells based on a guess of 4% being cells with stem cell characteristics. Depending on whom you talk to, the percentage can be 2% or 10%. Some vendors will tell you that they have a proprietary technique that gives them an incredibly high yield. To add to all the confusion, we have to take into account the number of cells that actually survive the shipping of the product. These cells are typically shipped in dry ice and need to be used right away once they are thawed because they start to die. If the cells are going to be stored at the clinic, they need to be stored in a special cryo-freezer or in liquid nitrogen. You can’t just stick them in the freezer in the kitchen.
Autologous cells are harvested from the bone marrow by doing a bone marrow biopsy or they can be harvested from fat by doing a liposuction. Stem cell treatments from bone marrow has been around for decades. When a patient receives a bone marrow transplant after chemotherapy or radiation, these treatments knock out the rapidly diving cells such as cancer cells and the patient’s stem cells. A donor’s bone marrow is introduced into the patient to repopulate the stem cells that were killed by the treatment. The patient’s own bone marrow is not used for this type of treatment because the autologous bone marrow may have cancer cells in it. Marrow from a healthy donor is used. When treating orthopedic conditions, autologous bone marrow can be harvested and used in the same patient. This avoids the hassle of finding a matching donor. Because bone marrow treatments have been around for a while and have gone a few rounds with the FDA, there has been some leeway in calling bone marrow derived cellular treatment “stem cell” treatments. Practitioners should still make it clear to patients that “stem cell” may not be an accurate description of the treatment.
Adipose derived cells are harvested by performing a mini liposuction. This is a technique that is growing in popularity because fat is usually abundant and expendable. Found within the vasculature that nourishes the fat cells, are mesenchymal cells that that have stem cell characteristics. The most popular way of separating the regenerative cells from the fat cells is by using an enzyme to cleave the cells off the fat. The FDA seems to have an issue with this technique because they feel that this may be more than minimally manipulated in which case, doctors are making a drug in the office. The jury is still out on whether this technique will be allowed to be performed in the future. Another way of obtaining the cells from the fat is by mechanically disrupting the cells to separate them. We are hoping that the FDA will see this as a minor surgical procedure rather than a treatment with a “drug” created in the office.
Amniotic fluid has been found to be rich in growth factors with very potent regenerative effects. Stem cells have also be found in this unique fluid that nourishes and protects a baby in the uterus. This fluid can be used directly for regenerative treatments but we should not call this a stem cell treatment or even a cellular treatment because the number of live cells in this fluid is so small.
The newest trend is to isolate the secretions from the stem cells. The secretions are the signal that the stem cells and other regenerative products send out to initiate your body’s own dormant stem cells into becoming active and start the healing cascade. These secretions are called exosomes. Exosomes are so small that they can be filtered to remove all cellular debris making them very clean with minimal risk of immunologic reactions from the recipient. Since there are no cells in this product, these are not considered stem cell injections by any stretch of the imagination, but they may have regenerative characteristics as potent or even better than live cell treatments.
The bottom line is that all of these treatments seem to work with a variety of different documented clinical outcomes. Ongoing studies are providing us with more and more evidence that these biological treatments may provide therapeutic improvements in a plethora of different conditions. How well each type of therapy works and for which conditions they work will depend on many variables. The quality of the product being used and the skill and knowledge base of the practitioners administering the treatment will play a vital role in the effectiveness and safety of the treatment.
Although treatment with biologicals is quickly becoming mainstream, the FDA still considers these treatments to be experimental. Using the word “Stem Cell” is raising red flags with the regulatory bodies because this terminology is being used so loosely. Since technically, only embryonic cells have true stem cell characteristics, we should refrain from calling these “stem cell treatments” so that we do not mislead the public. Even though we have plenty of anecdotal evidence of these treatments causing miraculous changes in our patients, we should not be making any claims or promises that the treatment will do any of these things for the individual patient.
Practitioners providing these treatments need to adhere to the utmost ethical standards and not even appear to be taking advantage of desperate people who have nowhere else to turn. The public trust is so important in allowing this incredible science to change the way healthcare is delivered. We must hold each other accountable and think about what is best for the patient.
Patients need to be aware that there are people who will try to sell you a treatment that may not be right for you. They may make promises and claims to get you excited and take your money without letting you know that the treatment may not work on everyone. They may pressure you with hard core sales tactics and misrepresent the quality of the product you are getting. You should be given an informed consent to sign to indicate that everything has been explained to you, but you should not have to sign a contract or made to feel like you are losing out if you don’t sign today. You should be informed about all of your options including FDA approved treatments that are available through conventional medicine. You should make your decision based on a clear understanding about the treatment you are about to receive, not out of fear.
Is a “Stem Cell” treatment right for you? The best way to decide is to educate yourself about what you can and cannot expect from the treatment. These treatments are typically not covered by insurance. When performed by legitimate practitioners, these treatments are very low risk. The biggest risk is usually financial. You need to be properly informed so that you can make an educated decision. Don’t jump in to get a treatment just be cause someone gave you a free dinner and a lot of hype. There are true caring doctors who want to help you get better with the right treatment. Take your time and find the right doctor.
The Story of Your Stem Cells
Remember how fast you used to heal when you were a kid? As we get older we take longer and longer to heal from even the most minor of injuries. Sometimes we are left with chronic pain that never seems to heal. Wouldn't it be great if we could get our bodies to heal like it did when we were kids?
Stem Cells are the building blocks that our bodies use to regenerate tissue and repair injury. When we are young, we have an abundant supply of stem cells to perform repairs quickly and efficiently. As we age, we start to lose stem cells and it takes longer to perform even simple repairs. The goal of regenerative medicine is to find ways to help our bodies utilize our own stem cells more efficiently and if needed, provide additional stem cells to regenerate and heal.
We used to think that stem cells were only found in embryonic tissue and in the bone marrow. It turns out that stem cells are actually everywhere, even in adults. Adult stem cells, also known as mesenchymal cells are found resting along the vast capillary beds all over our bodies. They are even found within fat cells (adipose tissue). This is significant because fat cells are generally considered to be expendable, and thus a great source for harvesting stem cells.
In response to an injury, signals are sent out to cause the resting stem cells to migrate to the area and start repairing and regenerating damaged tissue.
The signal is initially sent out by the platelets that aggregate at the site of injury. Once on location, the stem cells also send out their own signals to attract even more stem cells.
Once enough stem cells have arrived at the work site, the cells start to multiply and transform (differentiate) into the kind of cells needed to repair the damage. Stem cells can form new cartilage, new bone, new skin, new collagen and even new blood vessels.
As we age, the number of available stem cells start to decrease, making it more difficult to heal. Regenerative therapies help to amplify the signal that attracts stem cells to an injury. Treatments are now available to recruit and even replace stem cells so that you can heal naturally, like you did when you were younger!
What are Your Options?
At Omni Health Professionals we can help you find the most appropriate treatment so that you can feel better, get off of dangerous drugs and, in many cases, we may even be able to help you avoid major surgery. Unlike other "Stem Cell" clinics, we have multiple treatment modalities available and we have the expertise to help you choose the best treatment that meets your specific needs and budget. There is no need to travel out of the country to receive the most advanced cellular and regenerative therapies. Come and find out how we can help you feel better now. No surgery, no drugs, just the most advanced cellular medical therapies:
Biomodulation with Laser, LED, Radiofrequency and Accoustic Wave therapies
Platelet Rich Plasma (PRP) treatments
Cell Derived Growth factors from donated Cord blood, amniotic fluid, or amniotic membrane.
Injections of Autologous Regenerative Cells harvested from your own bone marrow or fat.