Science and misinformation surrounding amniotic, cord blood, placenta stem cell therapy

Ross Hauser, MD.,Danielle R. Steilen-Matias, MMS, PA-C

There is a great amount of misinformation surrounding “amniotic stem cell therapy,” and “umbilical cord blood stem cell therapy.” We hope in this article we can help you understand what these treatments are and what these treatments are not. These treatments can help people, however, at this time we choose not to offer them.

The primary reason we do not offer these products is that we do not find them to be more effective or economically viable to the patient than the utilization of the patient’s own stem cells (which we rarely offer) and because we find simple dextrose Prolotherapy and Platelet Rich Plasma (PRP) to be effective treatments which, in our observations, yield similar if not better results.

There is also a question as to whether this is actually stem cell therapy. It is an injection and then there is a debate as to what is it an injection of?

In many of our patients, we find the goals of treatment can be achieved without the use of stem cell therapy. How can we say that? More than twenty-eight years of clinical observation.

• The first thing that should be pointed out about amniotic/placenta stem cell therapy and umbilical cord blood stem cell therapy is that there are many doctors and researchers who suggest that there are NO stem cells in the treatment.

If there are no stem cells, why are they called stem cell therapy? That’s a good question.

• Many “stem cell” companies buy amniotic/placenta tissue and cord blood from tissue banks. The cord blood is remnant blood usually collected from that which remains in the placenta.
• The tissue banks get the afterbirth materials from hospitals who collect the material for laboratories doing scientific research or for companies who can make medical products out of them. Some amniotic tissue preparations are used for foot ulcers for example. Some cord blood is used to help patients with blood disorders.
• It should be pointed out that in almost all cases, there is not someone waiting at the blessed birth event to collect the afterbirth to send it to your doctor for injection into your knee. As mentioned, afterbirth material is generally collected in the hospitals’ maternity ward. There may be consent forms the mother’s sign that allows their afterbirth material to be used for medical needs and scientific research. Therefore they become “donor mothers.”
• The “stem cell” companies buy this material and must process the amniotic membrane and fluid for preservation and to remove disease and other unwanted hazards.
• The processing destroys the amniotic stem cells. “Amniotic stem cell therapy,” therefore can not contain living stem cells.
• The “healing” factors of amniotic tissue treatment are the growth factors found in the remnant of the extracellular matrix of the amniotic tissue and well as remnant natural hyaluronic acid. (Learn more about  Extracellular matrix (ECM) and cell signaling).

Sometimes contaminated batches of amniotic/placenta/umbilical cord blood material get out.

On December 20, 2018, numerous news outlets reported that 12 people were hospitalized during the course of 2018 because of contaminated umbilical cord stem cell therapy injections. This story first appeared in the journal Morbidity and Mortality Weekly Report (MMWR), (1) from the U.S. Department of Health and Human Services, Centers for Disease Control.

These are talking points from the CDC report:

• 12 people were hospitalized over the course of 2018 because they received “umbilical cord stem cell injections,” contaminated with fecal matter and bacteria.
• The most serious case of hospitalization was a patient who was hospitalized for 58 days after receiving a “cord blood stem cell injection” into the lumbar spine. The patient suffered infections in the bloodstream, lumbosacral epidural abscess, discitis (inflammation of the discs), and inflammation of the bone of the vertebrae. A patient at another pain clinic spent 30 days in the hospital with a blood infection after also receiving a “cord blood stem cell injection” injection into the lumbar spine contaminated with fecal matter and bacteria.

Reports of contamination are of course also concerning and warrant attention. Contamination warnings are not limited to stem cell treatments, most recently romaine lettuce and other meat and food products have been recalled for contamination.

Amniotic “stem cells” marketed in many chiropractic offices are, in reality, micronized amniotic fluid. The micronization process takes amniotic fluid, freeze-dries it, and then processes it. The process kills the stem cells. NO live stem cells are present. However, growth factor remnants remain.

Many people attend seminars on the benefits of amniotic stem cell therapy. These seminars are often conducted by a chiropractor whose presentation includes a segment on how the attendees of the seminar have joint pain because their own stem cells are too few, too weak, too feeble and too old to repair the damage.

The great irony of this argument is if you have been told that your own stem cells are too few, too weak, too feeble and too old, how does the amniotic tissue then work if it has no new stem cells in it?

• The entire concept of how “amniotic stem cell therapy,” works is that it relies on the remnant growth factors not donated living stem cells. The remnant growth factors in the donated amniotic tissue stimulate your own stem cells to work.

For amniotic tissue treatment to work, it must work at the expense of debunking its own marketing claim that your stem cells are too few, too weak, too feeble and too old to work.

Many people leave stem cell seminars convinced that their own stem cells are no good and that donated amniotic stem cells will help them with their chronic joint pain. This is inaccurate. So much so that one company was asked to stop their current marketing practices by curtailing claims of what amniotic tissue was and could do by the FDA’s Inspections, Compliance, Enforcement, and Criminal Investigations unit. Other amniotic stem cell companies followed suit and put up FDA disclaimers about their amniotic fluid products. Some websites simply disappeared.

Clearly, amniotic stem cell therapy is not donated stem cells working in your damaged joint, it is in fact growth factors that activate your own stem cells.

The amniotic stem cell fact check:

• The amniotic fluid contains an abundance of mesenchymal stem cells (MSCs) that originate from the fetus.
  • Actually, the amniotic fluid does contain an abundance of mesenchymal stem cells in its nature pre-donated state.
  • They are all killed in the processing.
• Amniotic stem cells have a higher expansion potential than the ones derived from the bone marrow which means that more new tissue cells can be derived from the amniotic fluid.
  • Actually, amniotic stem cells do have a higher expansion potential in their natural pre-donated state.
  • Unfortunately this benefit is also killed in the processing.
• Amniotic stem cells possess enhanced stability and plasticity compared to adult stem cells allowing them to develop into healthier cells needed for tissue repair.
  • Unfortunately this benefit is also killed in the processing.
• There’s no risk of the patient rejecting the stem cells.
  • There is no risk because you are not getting any stem cells.

Human amniotic membrane (HAM) and human amniotic fluid-derived cells (HAFCs) do help people

The above section of this article deals with the idea of amniotic stem cells from afterbirths and the concept of getting live stem cells. Sometimes using semantics it is called amnoitic stem cell therapy because the fluid that is processed out are remnant of the once living stem cells. However good research shows that human  amniotic fluid-derived cells, minus the word stem, can help people.

A September  2022 paper in the Journal of pain research (5) comes to us from multiple authors including those from the Mayo Clinic and the Icahn School of Medicine at Mount Sinai, New York. The authors write: Human amniotic membrane (HAM) and human amniotic fluid-derived cells (HAFCs) contain properties that present potential for alleviation of osteoarthritis disease progression. Amniotic tissues consist of anti-inflammatory factors that upregulate anti-inflammatory pathways, high hyaluronic acid and proteoglycan content, as well as regenerative chondrocyte differentiation properties.

Amniotic-derived tissue product vs cortisone for knee osteoarthritis

In July 2022, Emory University researchers wrote in the journal Regenerative medicine (4), of their comparison of a single injection of an amniotic-derived tissue product (dehydrated cell and protein concentrate) to corticosteroid. Fifty-one patients were enrolled in the study (27 patients received amniotic-derived tissue product, 24 patients received corticosteroid). Both groups demonstrated improvement in pain and function six months after treatment. There was a larger improvement in the amniotic-derived tissue product group, but this did not reach a level of statistical significance.

Growth Factors in stem cell therapy and Platelet Rich Plasma Therapy

Platelet Rich Plasma is a treatment where you own blood is centrifuged to separate out growth factors found in your blood platelets. This gives us a platelet rich plasma that is injected back into your damaged joints.

The key to regenerative medicine is growth factors. Adipose (obtained from a patient’s fat) stem cells contain live growth factors. Bone marrow stem cells contain live growth factors, Platelet rich plasma (PRP) contains live growth factors. Micronized amniotic fluid contains growth factors, NOT stem cells.

Initial comparison…

• Adipose (fat) stem cells contain live growth factors and live stem cells.
• Bone marrow stem cells contain live growth factors and live stem cells.
• Platelet rich plasma (PRP) contains live growth factors.
• Micronized amniotic fluid contains processed growth factor material.

Is your own blood just as effective or better than amniotic material?

Platelet Rich Plasma Therapy is an injection of growth factors drawn from your own blood. In our practice, this is not a stand-alone treatment. It is supported by the injection of a dextrose-based solution, the treatment best known as Prolotherapy. This is a comprehensive program to treat the whole joint. This is best explained in the video below as demonstrated on a patient’s knee.

With PRP Prolotherapy, we draw your blood from your arm. The blood is then centrifuged to separate the healing platelets for easier collecting and processed right in the office. These concentrated platelets are then injected back into the problem area(s).

There is a long list of research papers on the benefits of healing degenerative joint disease with PRP healing factors. This is covered in my article: What is Platelet Rich Plasma Therapy?

Briefly, research has shown that:

• PDGF (Platelet-Derived Growth Factor) found in your own blood initiates connective tissue healing through collagen and protein production.

Stem cells have to eat. Is simple sugar better than amniotic stem cells? How Prolotherapy helps feeds your own stem cells

Of obvious interest to doctors and researchers is how to make stem cells more viable and effective in the diseased joint environment. The answer may be glucose or dextrose, which is the main ingredient used in traditional Prolotherapy injections.

Stem cells have to eat. One of their favorite foods is glucose, simple sugar. Glucose is one of our great energy sources. Doctors and researchers have written for years that stem cells can be activated to work better if they are in a glucose-rich environment. Here is an example of the research.

• One source of injectable stem cells is adipose (fat) tissue as mentioned above. Adipose-derived stem cells are an excellent source of multipotent stem cells (cells that can transform themselves into other cells, i.e., cartilage) and are capable of differentiating into a variety of other cells that are useful for musculoskeletal conditions.
• Researchers at Duke University subjected human-adipose-derived stem cells to concentrations of glucose. Of interest in this study was not only did the higher concentrations of glucose cause the stem cells to proliferate (grow), but their differentiation into osteogenic (bone) stem cell lines was only observed when the glucose concentrations were physiologically at normal to high levels.(2)
•  In other words, the glucose helped stimulate bone repair.
• An important paper on stem cell research from Purdue University confirmed the notion that dextrose, especially hypertonic (high level) dextrose is a significant factor in the ability of mesenchymal stem cells from bone marrow to proliferate.(3)
• The mesenchymal stem cell consumption of glucose increased proportionally with the glucose concentration in the medium. The higher the glucose concentration in the medium, the greater the glucose consumption by the bone marrow stem cells. The primary results note that the higher glucose and serum concentrations appear to produce higher cell populations over time.

More than 28 years of Regenerative medicine, tens of thousands of patients.

Our clinic has been offering regenerative medicine for over 28 years. We have always explored many new healing opportunities for our patients. While amniotic material therapy may provide results for some, we do not offer it because the results are not consistent, the cost is more prohibitive, and many of the claims made are not backed by good science.

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