Del Mar Integrative Medicine & Med Spa

STEM CELL THERAPY

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Over the past several years, umbilical cord stem cell therapy has become extremely popular. Several biological components combine to make up regenerative therapy with these "products of conception," including:

The Umbilical Cord

Umbilical Cord Blood

Wharton’s Jelly

Placental Membrane

Amniotic Fluid

First of all, it should be noted that these products DO NOT contain embryonic stem cells or involve aborted fetuses. That would be both unethical and illegal. All of R3 Stem Cell’s Centers of Excellence only use products that are obtained ethically and processed at FDA Certified labs.

In the same fashion that the umbilical cord, placenta, and amniotic fluid protect the growing baby and help it thrive, these biological cells have shown to be instrumental in helping repair and regenerate damaged tissues in the body. It’s been very exciting to see the outstanding outcomes achieved with the usage of umbilical cord materials!

Overview

Regenerative medicine refers to therapies that are able to repair, restore, and regenerate damaged tissues in the body. These therapies represent a significant advancement from traditional ones that only offer symptom relief as a proverbial "band-aid.

Regenerative procedures come in two forms. Those that require a biologic harvest from the patient (bone marrow or adipose tissue) or those that come from an external source (e.g., PRP Therapy, amniotic fluid/membrane, and umbilical cord blood/tissue).

Significant myths and misinformation have been propagated regarding the external source of regenerative biologics. Many of these myths are disseminated by industry competitors who have presented biased and manipulated data to confuse prospective patients.

What Do They Contain?

Known as the "products of conception," the regenerative materials from amniotic and umbilical tissue include the following:

Amniotic Fluid

Placental membrane

Umbilical Cord Tissue

Umbilical Cord Blood

Wharton’s Jelly

How Are They Acquired?

The amniotic and umbilical cord tissues are obtained from healthy, consenting donors under the age of 35 and undergoing a scheduled c-section. The FDA strictly regulates the process of how these tissues are acquired, tested, processed, and stored to ensure the highest level of patient safety.

During a regular, scheduled c-section, the products of conception are normally discarded. This includes the amniotic fluid, placenta, umbilical cord, and accompanying materials. In this case, the products of conception are donated by the mother, with the baby being fine. The materials are placed in a sterile container and taken to the nearby FDA-registered, certified laboratory right away.

Are there any ethical issues with these biologics?

No, there are not. None of the biological materials come from "aborted fetuses." During the biological acquisition, the babies are fine, and the material donated and used is normally discarded.

In addition, no embryonic stem cells are legally used in the US anymore. There is no fetal tissue or cloning, and all donors are consented to and screened according to FDA regulations.

This means there are NO ethical concerns with the materials being used from the products of conception.

Difference Between PRP & Stem Cells

PRP stands for platelet-rich plasma and involves a simple blood draw from the patient. This blood is placed into a kit and spun quickly for 10-15 minutes in a centrifuge machine, thus separating the blood into several layers.

The middle layer is termed the “buffy coat” and contains concentrated platelets, white blood cells, and 8-12 growth factors. There are minimal stem cells in PRP, if any, so it is a very helpful regenerative biologic but not a stem cell therapy.

Amniotic and umbilical cord materials contain over 80 growth factors along with an extensive amount of cytokines, mRNA, exosomes, secretomes, and additional biologic elements, including stem cells. The amount of these elements varies depending on the lab that processes the material and the amount of preservative and radiation, among others.

Are all amniotic and umbilical cord products the same?

The short answer is no. While the actual biological material from the donor is extremely similar, the processing can vary. All donors are heavily screened for diseases and are under the age of 35. The DNA factors are removed to prevent rejection, making the biological material immunologically privileged.

The main differences occur when the material is processed at the FDA-certified lab. While the FDA is strict about how the materials are processed, there are some significant differences that can take place. For instance, some labs will radiate the biologic, which essentially kills all the cells. Others will use a lot of preservatives, which will kill all the cells instead of preserving them.

Suffice it to say that not all of these products are the same once processing is complete. So it is critical to receive treatment from an expert provider who is using a quality product. R3 Stem Cell has vetted the materials used extensively, which is just one reason why over 10,000 patients have received treatment at our Centers of Excellence over the past six years.

Why Are Regenerative Procedures With These Products So Popular?

No harvest

Bone marrow-derived stem cell procedures require an aspiration from the patient's iliac crest (pelvis). Studies have shown a 29% incidence of chronic pain from the aspiration procedure along with the potential for additional complications such as nerve/vessel injury, bowel perforation, and fracture.

In addition, as one ages, the quantity and quality of stem cells obtainable from the bone marrow drops exponentially. It is illegal in the US to culture one’s bone marrow to amplify cell counts. At birth, 1 in 10,000 cells in one’s bone marrow is a stem cell. This drops to 1 in 2 million by age 70. No matter how much one’s bone marrow is concentrated, the cell counts are a problem.

Adipose-derived stem cell procedures require a mini-liposuction from the abdomen or buttock. The first problem with this is that many patients simply do not have significant adipose tissue to spare.

The second problem with adipose procedures is interesting. Adipose tissue contains VERY HIGH numbers of stem cells. However, once the adipose is processed and moved to your treatment area, over 80% of them die within two days. So they do not even get a chance to help!

Safe

Studies have shown that bone marrow aspiration procedures have a high incidence of complications. Twenty-nine percent of patients end up with chronic pain, which is a real problem when the objective is to rid patients of pain. Can you imagine that conversation?: "Hey doc, my knee feels awesome, but what did YOU DO TO MY HIP!

Additional complications reported from bone marrow aspirations include infection, bleeding, nerve/vessel injury, bowel perforation, and pelvic fracture.

The mini-liposuction procedure does not have a high incidence of complications. However, as mentioned, most of the stem cells from that procedure die within 48 hours. Real bummer.

On the other hand, all of these issues are avoided by not having to use a harvesting procedure.

In addition, the amniotic fluid does not have HLA factors in sufficient quantity to cause a rejection in the recipient. Also known as MHC factors, these are the cell components that would lead to a Graft versus Host reaction if they were present in sufficient concentrations. The amniotic fluid is immunologically privileged as a result.

The umbilical cord tissue/blood material could cause a rejection reaction if not treated properly. For example, if one receives a blood transfusion from an incompatible donor, the blood will be rejected with a potentially severe reaction. All red blood cells are removed from the umbilical cord blood to prevent that from happening. This removes the HLA factors and prevents the Graft versus Host reaction.

Consistent

Amniotic and umbilical materials are very consistent. When the processing occurs at first rate labs certified by the FDA, the amount of cells is very high and extremely consistent. Unlike adipose and bone marrow, where the cell counts drop big time with aging and the quality of those cells diminishes as well.

One thing that should be noted is the myth that there are no live cells in processed amniotic fluid. The FDA does not require the material to be radiated; if a low amount of preservative is used, the cells survive the processing. In addition, cryopreservation does not kill cells. (If it did, egg donor programs would go out of business.) So labs that don't radiate and use minimal preservatives get plenty of live cells!

Excellent outcomes

When you look at the very high Benefit profile and the very low Risk profile of these materials, in medicine that is called a HOME RUN!

How Many Treatments Will It Require?

On average, patients can see the effects and potential relief within 4 weeks of the initial treatment.
This is not covered by insurance. Prices start at $2,500

Will It Cure My Condition?

It is improper for ANYONE to provide an unrealistic expectation of what these therapies can do. Using the words "heal" or "cure" is inappropriate and propagates distrust among patients. No study shows 100% effectiveness; more likely than not, patients will see improvement and relief, but NOT a cure. We get asked all the time if our affiliated providers offer a "Guarantee." The answer is no because medical procedures are never foolproof. More reasonable words to use are "facilitate," "mitigate," or "improve." The biological elements in these materials work together to repair damaged tissue and facilitate one's own body to assist in the process. Just how much improvement is achieved will vary since people are UNIQUE AND DIFFERENT!

How Exactly Do These Materials Work?

The father of modern stem cell therapy is Dr. Arnold Caplan, a researcher at Case Western Reserve University. His extensive work has shown that the regenerative materials used predominantly act as signals to one's body, telling the body to "get to work" and repair itself. He recommends changing the abbreviation of MSCs, which usually stands for Mesenchymal Stem Cells, to Medicinal Signaling Cells. The goal is to "more accurately reflect the fact that these cells home in on sites of injury or disease and secrete bioactive factors that are immunomodulatory and trophic (regenerative), meaning that these cells make therapeutic drugs in situ that are medicinal." He continues, "It is, indeed, the patient's own site-specific and tissue-specific resident stem cells that construct the new tissue as stimulated by the bioactive factors secreted by the exogenously supplied MSCs.

"I was diagnosed with spinal stenosis at a very early age and suffered greatly for over 50 years. Epidurals, surgeries, acupuncture, and other treatments were ineffective or only gave me relief for a limited time. In June of 2019, I sow Dr. Kremer for a stem-cell procedure and it changed my life. I had a second treatment in December of 2019, and since that time, I have been 100% PAIN-FREE. At 72, my back is now the best it has ever been. Dr. Kremer's treatment gave me my life back...and I can not thank him enough!!!!"

-Johnnie J.