There are many ways patients can educate themselves on regenerative medicine. There are countless resources online and, if you’re in the right city, weekly regenerative therapy dinners, seminars and more all aimed at educating prospective patients on the benefits of these treatments. You can even attend online webinars on “stem cell therapy” virtually anywhere with an internet connection.
However, there are also lots of buzzwords thrown around that are either used incorrectly or by exact definition are misleading when used to describe regenerative therapies. While learning the meaning of these terms is helpful, it’s also a good idea to understand the context behind how these words relate to regenerative medicine.
Stem Cell Therapy
When we talk about regenerative medicine, it’s hard to not use the term, “stem cell therapy” even though it is technically incorrect. This is because of how many doctors are still describing their treatments using this term and, consequently, how many patients are continuing to refer to such treatments the same way.
The reality is that while regenerative therapies, such as those utilizing umbilical cord allograft, are shown in multiple case studies to have resulted in a positive outcome for the patients using them, the exact mechanism by which the improvement resulted has not yet been fully researched. As such, it is incorrect to claim or imply that there is cellular interaction from the usage of regenerative medicine products including those containing stem cells. This is why referring to a regenerative therapy as “cell therapy” is also wrong.
By definition, a stem cell is an undifferentiated cell of a multicellular organism which is capable of giving rise to indefinitely more cells of the same type, and from which certain other kinds of cells arise by differentiation.
One of the most common misuses of the term “stem cell” occurs when doctors or regenerative medicine distributors describe the contents of their regenerative therapy products. For example, a typical vial of umbilical cord allograft-derived regenerative medicine contains between 15-30 million cells. Referring to all of those cells collectively as “stem cells” is incorrect because the solution is actually a heterogeneous (diverse) mixture of cells including stem cells.
Many patients wonder if your body can “reject” stem cells that come from an outside donor, such as what would happen during an organ transplant that didn’t match. Because our cell products contain stem cells with the ability to differentiate into multiple cell types, your body doesn’t reject them in this way. These cells with the ability to differentiate are known as, “MSCs”.
In a typical vial of cells derived from umbilical cord allograft, there is about a 1-4% ratio of MSCs, or mesenchymal stem cells. These are the highly sought-after cells known for their regenerative properties.
Mesenchymal stem cells, or MSCs as they are known, are multipotent stem cells known for their ability to differentiate into various cell types. MSCs are believed to be directed to where they are needed by cytokines.
Cytokines are proteins that work as messengers and may be able to direct MSCs to where they are needed for their regenerative properties. An example of a regenerative medicine treatment that would aim to leverage cytokines would be a direct injection to a knee experiencing pain. The goal of the treatment would be for the cytokines to keep the MSCs in the location where they are injected for regenerative purposes, such as repairing damaged cartilage or tissue.
Umbilical Cord Allograft
Cell products derived from umbilical cord blood are considered umbilical cord allograft products. The umbilical cords are ethically donated following live births. There is a rigorous screening process for all our regenerative medicine products utilized by our doctors, including testing for 15 different diseases (current industrial standard is 7-8 diseases). Cell viability regularly tests at 90%+.
Platelet-rich plasma, or PRP, is a concentrate of plasma derived from whole blood, centrifuged to remove red blood cells. PRP may be combined with other regenerative medicine procedures such as those involving umbilical cord allograft treatments to maximize potential benefits. One of the most popular properties of PRP for usage in regenerative therapies are the growth factors present in the solution.
“More Than Minimal Manipulation”
You’ll hear this term a lot, especially when discussing FDA regulations. Products regulated under Section 361 of FDA guidelines, such as umbilical cord allograft products, may not undergo more than minimal manipulation in their production. Examples of processes that exceed minimal manipulation include duplicating of stem cells through artificial means, isolating MSCs from the heterogenous cell solution they are found in, and utilizing regenerative medicine products obtained from unauthorized sources or in unnatural combinations with other medicines.
All of our human cellular and tissue-based products (HCT/P) come from ethical sources and are regulated under FDA Section 361.
HCT/P refers to human cellular and tissue-based products such as umbilical cord allograft, Wharton’s Jelly, amniotic fluid and exosomes.
Most of the HCT/P products you will encounter for usage in regenerative therapies are only intended for homologous use. Homologous use refers to the intended function of the HCT/P to maintain the same function in the recipient as the donor. In other words, the cells coming from the donor are intended to take on similar cell functions in the recipient. An example would be umbilical cord allograft regenerative medicine being injected to a source of pain for the hopes of the MSCs taking on the cellular function of local cells for regenerative benefits.
An example of a treatment that is not considered homologous use is an IV infusion. This falls under systemic treatment and is not allowed under ordinary circumstances per FDA regulations as the MSCs may influence an entire system of the body and not just a problem originating from a single area.
Legality of IV Infusions
Are IV infusions illegal? While many individuals educated on FDA regulations may believe they are, the answer is not quite that simple. While it is better to error on the side of caution than to get yourself into trouble with the FDA, the answer is really dependent on the conversation the patient had with the doctor.
Patients have the “right to treatment” and doctors are allowed to conduct infusions at the request of patients seeking them. However, a doctor cannot actively market IV infusions with any purported benefits or lead patients in consultation to believe that there are any proven benefits to this treatment option. This is especially true when claiming “antiaging” benefits.
However, a patient may consider the testimonials of individuals that have undergone IV infusions and see what benefits they might receive from the treatment option for any doctor willing to offer it. What is most important for patients considering this kind of treatment is the understanding that there are no guarantees when it comes to expected results.
When referring to the benefits of regenerative therapies, some doctors may describe the treatments as having “antiaging” properties. There are many problems with this terminology.
First of all, there are many theories correlating the aging process with the loss of stem cells (and some studies to back it up). At birth, about 1 in 10,000 of your cells are stem cells. By age 70-80, only 1 in 2,000,000 cells are stem cells. It does stand to reason that stem cells are impacted by the aging process and the loss of stem cells may impact the body’s ability to naturally heal itself. While there are case studies showing that the introduction of donor stem cells may positively impact specific problems that are symptoms of the aging process, referring to regenerative therapies as “antiaging” treatments is misleading.
While regenerative therapies may treat the symptoms of many issues that result from aging, there is no “cure” for aging. While some qualified patients may report an increase in energy levels or a reduction in pain following regenerative therapies, calling them “antiaging” benefits is misleading.
At Vitality Regenerative, we will never quote a success rate for any of the procedures our doctors offer. This discussion is between you and the doctor. The reason we do not discuss success rates is the fact that every patient’s experience with regenerative medicine is different. We recognize that even a procedure reported to have an 80% success rate is based on the assumption that all the patients undergoing the procedure are qualified candidates. As we are not doctors and cannot review your medical history to determine that you are perfectly qualified for the treatment you are considering, we leave it to the doctors to evaluate your probability of success in undergoing a treatment.
That being said, our goal through our complimentary consultation services is to make sure there is nothing obvious that disqualifies you from the procedure and to make sure that you have the right expectations regarding the outcome of your treatment.
“Guaranteed” & Other Absolutes
There are no guarantees when it comes to the expected outcomes from regenerative therapies of any kind. Therefore, patients must exercise caution when working with any doctors or entities that speak in absolutes. Your consultant should speak using words like “maybe” and “may” over “definitely” and “will”.
From a sales perspective, we are NOT closers. Our goal during consultation is to get you accurate information about regenerative medicine so you can make the right decision about whether or not the therapies are right for you. We work with a network of doctors and are selective about who we choose to work with. We don’t have a “quota” and value our reputation more than the value of a patient referral if something isn’t 100% right with it.
Since we are compensated through patient referrals, there is no cost for a consultation with our agency. Furthermore, there is no obligation to purchase services at any time.
Client vs. Patient
This distinction is particularly important for clients of Vitality Regenerative. While you are working with us, you are a client. We are not doctors and cannot review your medical history with the same detail that a doctor can with a patient. What we can do, however, is prequalify you for treatment by asking questions about your history to make sure there is nothing that would disqualify you from treatment. Many of our conversations simply involve educating our clients about regenerative medicine so they can decide on their own if the treatments are right for them before scheduling a consultation with a doctor in our network. If we do not feel that you have the right expectations from your treatment and a good probability of success, we will not recommend you to a doctor in our network.
No physician-patient relationship will be established between you and any doctors in our network or out of network until such time as you register as a patient of that clinic and are seen by a member of their staff.
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Individual conditions, treatment and recovery times may vary. Each patient’s experience with regenerative medicine is different. Some patients may require additional treatments.
The content of this website and/or social media is for informational purposes only. We are not doctors and do not represent information we share as medical advice. Nothing contained in this website and/or social media is intended or shall be construed to constitute professional advice for any purpose including medical diagnosis or treatment. No physician-patient relationship will be established between you and any doctors in our network or out of network until such time as you register as a patient of that clinic and are seen by a member of their staff.
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