ECV - Extra Cellular Vesicles

Exosomes are tiny vesicles or sac-like structures, ranging from 30 to 150 nanometers in size, that are secreted by virtually all cell types. They are a key part of the cell's communication system and play a role in the transfer of proteins, lipids, RNA, and other molecules between cells.

Here's how they typically work:

1. Formation: Exosomes are formed inside the cell in endosomal compartments called multivesicular bodies (MVBs). When these MVBs fuse with the cell's plasma membrane, the exosomes are released into the extracellular space.

2. Release: After their release, exosomes can travel to other parts of the body through bodily fluids like blood, saliva, urine, and cerebrospinal fluid.

3. Targeting: Exosomes display molecules on their surface that can specifically bind to receptors on target cells, ensuring that they are taken up by the correct cells.

4. Uptake: Target cells can take up exosomes by different mechanisms, such as endocytosis or direct fusion with the cell membrane.

5. Function: Once inside the target cells, the cargo carried by the exosomes can exert various effects, such as altering gene expression, modulating immune responses, or even transferring pathogens between cells.

Exosomes are being intensively studied for their potential roles in disease, their utility as biomarkers for diagnosis, and their possible applications in therapies such as targeted drug delivery systems.

**The FDA presently regards exosomes and Cord Blood Stem Cells as substances that should be regulated as drugs, not biological tissues. Although several exosome products are undergoing phase two and three clinical trials, none have received approval yet. The FDA is intensifying its oversight of entities that manufacture, distribute, or utilize these products. Patients should be aware that there have been numerous instances of injuries linked to the use of allogeneic products. It is advisable to use one's own tissues until FDA-approved exosome and umbilical cord stem cell products become available.

Because of the stance of the FDA, Total Spine does not use ECV’s or Cord Blood Stem Cell Products at this time.

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