A regenerative medicine doctor (Dr. Charles Lee) recently asked the CBER division of the FDA if Wharton’s Jelly products were being correctly regulated and sold for use in humans. Guess what? The FDA said “NO” All allograft stem cell Wharton’s Jelly products currently on the market in the USA are being sold in violation of FDA regulations. Avoid any company and ALL doctors and clinics selling this stuff. On top of it all….there is no science that it even works for human orthopedic conditions anyway. This is why we only use bone marrow derived stem cells from your own body.
Common questions
- Is Wharton's jelly FDA approved?
- No. Dr. Charles Lee asked the FDA's CBER division directly whether Wharton's jelly products were being correctly regulated and sold for use in humans, and the FDA said no. Every allograft stem cell Wharton's jelly product currently on the US market is being sold in violation of FDA regulations. That applies to the companies making them and to the clinics injecting them.
- Does Wharton's jelly work for joint pain even if it is not approved?
- There is no science showing that it works for human orthopedic conditions. That is separate from the regulatory problem and, for a patient, arguably the more important half of it. A product can be both unlawful to sell and ineffective, and Wharton's jelly is currently both. The regulatory question gets more attention only because it is easier to document.
- What should I do if a clinic offered me a Wharton's jelly injection?
- Ask what the source of the cells is and what FDA approval the product holds, then decline if the answer is Wharton's jelly, umbilical cord, amniotic fluid or placental tissue. Texas Orthobiologics uses only bone marrow derived stem cells taken from the patient's own body, which is the one source that does not rely on an allograft product the FDA considers unapproved.
