There are almost too many red flags to count with the advertising of Stem Cell USA. http://stemcellusa.co
#1 The clinic lists NO doctor or health care, provider
#2 The clinic lists a wide variety of human conditions that they can treat with stem cells
#3 The clinic lists its stem cell source as placental stem cells….which means they are openly advertising a treatment in violation of FDA section 351 regulations and are selling and using an unapproved and misbranded biologic drug.(!!!)
Please tell your friends and loved ones interested in orthobiologics and regenerative medicine not to be scammed by these types of disreputable clinics and people (not even sure if there is a doctor associated with this one!)
This clinic has already been reported to the FDA and Texas State Medical Board……but consider this a public service announcement!
This time, the company is RichSource Stem Cells, whose CEO is Sara Oracle. On November 20, 2019, the FDA sent the company a letter detailed all of the falsehoods in the claims being mad by these companies when they sell their products to clinicians….and all the falsehoods that clinicians are selling patients when then sell these products. These products simply cannot be used in humans in the USA without FDA approval and 99% do not (Amniofix from a company called MiMedx has an approval for study and use for knee arthritis only) All of the rest of the companies should know better and are putting people’s health and safety secondary to their own profit motive.
This is why we only use bone marrow concentrate…from your own body….as the source for stem cells, and growth factors, another proteins and cytokines when we do our procedures at the Texas Orthobiologic Institute.RIchSource FDA Letter 11.20.19
* EXOSOMES * The Final FDA Word On Exosomes For Clinical Use In The USA. A well respected and thoughtful regenerative medicine doctor and educator recently took the time to do what I have been begging distributors and makers of allograft orthobiologics to do….ask the FDA about the regulatory requirements for their products! Thru the end of this year the FDA has a program called “TRIP” that is free and results in a prelim answer in 3 business days. Chris Rogers sent a letter asking whether exosomes are a biologic drug or not in the FDA opinion. The FDA CLEARLY says that these products are drugs and to be regulated under section 351. Kimera, we have a problem….because last I checked your exosomes were registered under section 361. ANY doctor buying or using exosomes improperly registered is putting their patients and their careers at risk. Patients and their attorneys and the state medical boards and board certifying entities will now have proof that exosomes being sold and used in humans are unapproved drugs. To use this product, we must first be regulatory compliant!
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.
FDA clearly states that umbilical cord blood is NOT exempt from registering as a biologics drug under section 351.
FDA states that “….using the umbilical cord blood products to treat orthopedic conditions is not homologous use as defined in 21 CFR 1271.3(c).”
If you are using or selling umbilical cord blood for use in orthopedics, regardless of stem cell claims or not….you better register thru section 351 or get a RMAT!!!
#orthopedics #stemcells #stemcell #regenerativemedicine #orthobiologics #orthopedicsurgeon #scams