CBSC - Cord blood Stem Cells

Cord blood stem cells are immature cells found in the umbilical cord and placenta of a newborn baby. They have the ability to develop into various types of cells in the body. These cells can be used in medical treatments because of their potential to regenerate and repair damaged tissues and organs. They are particularly valuable in the treatment of blood and immune system-related genetic diseases, cancers, and blood disorders. When transplanted, they can help rebuild a healthy blood and immune system in patients with certain conditions.

However, to safely administer someone else’s tissue into your body it needs to undergo a process known as terminal sterilization. A product that has undergone terminal sterilization has been exposed to irradiation to eliminate bacteria and viruses, which also destroys any human cells. This is considered the most secure method for utilizing tissues or cells from another person. Nevertheless, some firms bypass this process in order to market their products as 'living.' Adhering to pharmaceutical manufacturing standards, which is both challenging and costly, requires thorough screening of donors and rigorous contamination prevention throughout production. In light of ongoing CDC alerts, the omission of this step by these companies potentially endangers patients.

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.