A Comparison of Amniotic Fluid and Bio-Active Regenerative Fluid

A Comparison of Amniotic Fluid and Bio-Active Regenerative Fluid

Many of the amniotic fluid-derived stem cell products on the market are actual amniotic fluid extracted from the womb at the time of caesarean section delivery. This fluid goes through a filtering process to remove debris as well as metabolic waste byproducts.  If the amniotic stem cell product is not sterilized, there is the potential for adverse reaction based on the effectiveness of the filtering process.

Some companies simply cryofreeze the filtered liquid for use as a treatment.  Other companies isolate desirable growth factors and create a powder that can be rehydrated, similar to dehydrating coffee and then adding it to hot water later. Is this rehydrated product as good or as effective, as the original?

Many of these products claim to contain live stem cells. Stem cells are undifferentiated biological cells that can differentiate into other types of biological cells. They can also multiply and produce more of the same type of cells.  Even though a product can be marketed as having a certain cell count, there is a huge difference between cell count and VIABLE cell count. Viable cell count is the number of actively growing/dividing cells in a sample.

It is important to know that live cell products are NOT STERILE and need to be cryofrozen. Since the product is not sterile, contamination is a possibility. In addition, there is always a possibility of graft vs host disease. Also, any product claiming to contain live stem cells (other than hematopoietic cells used to treat blood conditions) does not meet the regenerative medicine gold standard, FDA regulation 361.

A vital consideration: any product or procedure claiming to contain live stem cells, even those taken from a patient, processed in some manner, and injected back into the patient, is basing those claims on a misunderstanding of the mechanism behind the therapeutic action of stem cells. In many cases, transplanted stem cells do not demonstrate a high survivability rate, and the rate of transdifferentiation of stem cells into surrounding tissue cell types has also been quite low.

It is now understood that the principle mechanism that contributes to tissue repair is the secretion of soluble growth factors into surrounding media that act in a signaling fashion. The observed effects of stem cell-related activity include anti-inflammatory immunosuppression, and the activation of resident stem cells in the area of interest. The signaling factors affect multiple cell types and create a microenvironment that promotes repair and regeneration at multiple time points. In fact, stem-cell conditioned medium alone has been shown to be sufficient in replicating the therapeutic beneficial effects of cells of the same type.

The in-utero environment is the most regenerative environment known. Our products come from the amnion, the innermost layer of the amniotic membrane, which is a rich source of various biologically active key growth factors, cytokines, amino acids, carbohydrates, hyaluronic acid, extracellular matrix (ECM) proteins, and cellular components recognized as intrinsic to the complex healing/regeneration process.  In addition, our amnion-derived regenerative fluid has anti-inflammatory, anti-bacterial, re-epithelialization, immune-privileged and antibiotic properties.  Our Bio-Active Regenerative Fluid is sterilized by irradiation and has an 18-month shelf life at room temperature.  It is THE cutting-edge stem-cell technology available today.