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Amniotic Stem Cells

Posted By :- Mitchell Bloom, July 24th, 2019

There is a great deal of excitement about the use of amniotic stem cells for a variety of painful conditions. Some claims about its results are nothing short of grandiose; promising miraculous, life altering changes that are able to cure arthritis, back pain and many other orthopedic conditions. These promises can seem very enticing; but are they justified, or just deceptive marketing for which some people are paying nearly $15,000 – to get injected with baby urine?

In December 2015 The Interventional Orthopedics Foundation issued a press release about faulty stem cell products after testing placental tissue-derived products. The warning stated: “THE PRODUCT CONTAINED NO LIVE CELLS.”

Researchers have found that indeed, the amniotic fluid has an extremely high concentration of stem cells, even more than bone marrow in adults. When processed at an FDA regulated lab, the biologic material was also found to contain regenerative factors, such as growth factors, hyaluronic acid, and stem cell activators. While this seems encouraging, the problem is that the stem cells do not survive the processing.

The basic fact is that according to third party testing (i.e. not sponsored by the manufacturer), amniotic preparations and Wharton’s Jelly, (the tissue inside the umbilical cord) don’t have any living cells. This is not the fault of the doctor or the sales rep. The innocent medical doctor is often told the amniotic product has living stem cells. The unassuming sales rep is often told that misinformation by the manufacturer in order to sell the product to the doctor. The unassuming medical doctor then passes on that misinformation to their patients.

Sadly, many patients attend live seminars and are enticed by promises of pain relief. Many are incorrectly told that their own stem cells are no longer functional; and even if they were, there are not enough of them. Rarely are the root causes of their pain addressed.

But before going any further, let’s back up a bit (well quite a bit – to the time of birth) to consider what we are really injecting. If a baby could talk, they would tell you that the amniotic fluid is the fluid sac in which a baby lives when inside the mother’s womb. This amniotic fluid is mainly composed of baby urine. The placenta is where that sac attaches to the mother’s uterine wall. The amniotic fluid does contain some beneficial growth factors including collagen and extracellular matrix.

With this in mind, let’s clear up some possible misunderstandings. As mentioned, although they did contain live stem cells at delivery; once the fluid is concentrated, cryopreserved, chopped up, freeze-dried, packaged and shock thawed for use, etc. no living stem cells remain.

Let’s also clear up another possible misunderstanding about the capabilities of amniotic cells. Even if living cells were present, amniotic stem cells are intermediate between embryonic stem cells and adult stem cells. They have some potential to develop into different cell types, but not any cell type. For amniotic cells to be able to differentiate into any cell type they need to be genetically modified. This would require special FDA registration.

Another misunderstanding is that amniotic products are FDA approved and have therefore gone through rigorous testing. The fact is, there are two pathways for FDA approval, the 361 registration which is very easy, and the 351 registration requiring hundreds of million dollars for cell drug registration. All amniotic and cord blood products have gone through the 361 registration which does not require clinical trials or data. This 361 process takes less than an hour to complete. If there were indeed any live cells present, it’s considered to be a drug and the manufacturer would need to go through real 351 FDA approval through the multi-million dollar registration process which takes many years.

The bottom line is that although amniotic preparations do not contain any viable stem cells, they do contain growth factors that may be helpful. The fact is, you don’t need to spend your hard earned money on expensive baby urine. Highly effective results can be obtained by using the Affordable Stem Cell Alternative Treatments discussed throughout this website.

Riboh JC, Saltzman BM. Am J Sports Med. 2016 Sep;44(9):2425-34. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications.

Disclaimer: All information provided by Dr. Bloom is for educational purposes only It is not intended to prevent, diagnose, treat, or cure any disease or injury. Individual results may vary. No results are guaranteed.