Stem cells, or Wharton’s Jelly Allografts, or Human Cellular Tissue, all are the same thing. The FDA is not allowing the use of the term “stem cells” any more, so doctors are calling them all of these things.
No, these products are not FDA approved. The FDA says there is not enough research done on these products in order for them to be FDA approved. These products are regulated by the FDA. This means that the FDA has given guidelines that labs that sell these products to providers must follow.
Just because a product is not FDA approved, does not make it unsafe or dangerous. There are many products in the market that are not FDA approved. Nutrition and vitamins that you purchase regularly are likely not FDA approved. The FDA simply does not have the manpower to review every product that comes onto the market. That plus the amount of new products coming out regularly, creates an impossible situation for the FDA. They simply can not keep up. In some cases, yes, you should be wary of products that are not FDA approved. There are a lot of “snake oil” products out there, especially in the vitamin/nutrition arena. In the case of regenerative medicine, it is a different situation. There are a lot of labs out there offering regenerative medicine products, so it is up to the doctor to find a trustworthy, reliable lab that provides a good product. Remember, the doctor administering the product is ultimately responsible and is putting his/her license on the line with every treatment they approve or administer. So, you should do your research and find a clinic that you feel comfortable with, one where you trust the doctor and the medical clinic administering the product.
We have been in the regenerative medicine field for almost 20 years, so we have seen and heard it all. The medical staff in our office has a combined experience of over 100 years in regenerative medicine! We have treated everyone from professional athletes to pre-teens, and have injected every body part imaginable with regenerative medicine products.
We also have done a lot of research on where we get our regenerative medicine products from. One of our labs has 13 government certifications, so if anyone in the military, NSA, DOD, etc. needs a regenerative medicine injection, they exclusively use this lab. We have access to this product and have seen great results with it. The other lab that we use participated in a study on “Wharton’s Jelly allografts” and was approved by Medicare. These two labs have gone through great lengths to get this recognition and to be trusted by the federal government and Medicare respectively. That is why we feel like our products are safe and effective. Yes, these regenerative medicine products are not FDA approved, but these are very good references none the less.