* 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.
A federal court just affirmed the FDA’s claims and injunction against against US Stem Cell and two of its employees/principals.
Basically, the federal court once again confirmed that adipose tissue and especially enzymatic digestion of adipose to make an orthobiologic called SVF is NOT allowed unless the product is properly regulated by the FDA as a biologic drug. US Stem Cell did not properly register their processes or products and on inspection the FDA found many deficiencies in their business practices. Basically, this will have the effect of shutting down US Stem Cell’s adipose tissue “stem cell” practices in the USA. It also means that The Cell Surgical Network, another similarly operating chain of clinics, will likely have the federal court action upholding the FDA injunction against its network. The FDA has moved first against these two networks in part because of horrendous complications that clinics in both networks caused with improper drug creation and processing and delivery….along with flawed medical protocols that in Florida led to the blindness of several patients.
The new FDA director looks to be continuing the FDA enforcement actions and let’s hope that these efforts continue!
Any clinic still using adipose/SVF as a stem cell source should probably stop now!
The Park Avenue Stem Cell clinic is a former Cell Surgical Network affiliate which is a network whose founders (Drs. Mark Berman and Dr. Elliot Lander, are currently entangled with their own legal struggles with the USA Justice department over their stem cell clinic claims and activities.
The AG is seeking permanent injunction on the basis of “fraudulent and illegal advertising regarding its stem cell procedures.” The alleged fraud was based on the clinic selling an adipose/stromal vascular fraction stem cell therapy as a treatment for “…urological diseases, erectile dysfunction, cardiac/pulmonary disease, neurological diseases such as Parkinson’s disease and ALS, various autoimmune diseases such as lupus, and orthopedic conditions.”
Additionally, the clinic is accused of misrepresenting that the treatments were “FDA-approved, that their patients are participating in an established research study” both very common lies told to patients by clinics trying to justify these alleged scams. Finally, the AG is seeking a return of profit, and a potential penalty of $5000 PER PATIENT!!
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
Ok, just kidding, FDA doesn’t endorse any stem cell sources….BUT the FDA doesn’t regulate bone marrow as a stem cell source when used in orthopedics and they DO regulate adipose(fat), amniotic fluid, umbilical cord blood, placental tissues, and other stem cell sources used in orthopedics as biologic drugs. So, stick with the one source that is given the “top-line” exemption for use by the FDA. Here is a 15 minute video on why the FDA doesn’t regulate bone marrow in orthopedics.