It’s the question that I get asked everyday.
Is PRP approved by FDA? Is P-shot approved by FDA? Is O shot? Vampire facelift? What all these questions mean is, I don’t know what FDA does.
First let’s talk about what FDA stands for. Food and Drug administrations. (I am surprised at how many ppl think F stands for federal). They “approve” or disapprove, food, drug, and medical devices. Since umbilical cord tissue is not food, drug nor medical device, FDA does not approve or disapprove, but they regulate. These human tissue products are regulated as FDA 361 human tissue products and regulated to ensure that they are clean and safe. It also needs to meet a certain requirements such as minimal manipulation and homologous use. The tissue labs who process the tissue also have abide by the FDA rules and regulations and must be fully compliant with American Association of Tissue Banks.
Same thing goes for PRP and PRP procedures. The kits that produce PRP must be approved by the FDA however it is up to the doctor to decide how the PRP is used.
Be sure to seek these type of treatments with the doctors and clinics who does due diligence to ensure the tissue product is clean and safe. Recently, there was a FDA recall on a umbilical BLOOD stem cell product marketed by Livyon (manufactured by Genetech). Their tissue was found to contain e.coli and other bacteria, and the blood cells caused severe rejections in many patients. Personally I do not work with labs who doesn’t allow me to visit. There is just too much at a stake for me to just take a sales rep’s words. In February, I am re-visiting a few labs to meet with the science directors to learn what the latest technology is. I will also be attending Perinatal Stem Cell Society Conference. I will keep you guys updated on what I learn in the stem cell industry.
Until next time. Dr. An