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!
Category: Legal Issues With Regenerative Medicine (USA)
Mounting legal problems for clinics using fat/adipose stem cells in orthopedics
Any clinic still using adipose/SVF as a stem cell source should probably stop now!
The NY Attorney General has just filed lawsuit against Park Avenue Stem Cell and Dr. Joel Singer for selling adipose/SVF derived stem cells.
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 $!!
FDA Just Reaffirmed That You Can’t Use Umbilical Cord Blood in Orthopedics Without A Drug License Or Specific Permission Thru a RMAT Or Other FDA Program
3/29/2019
https://lnkd.in/eR7Jpq2
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
Why the FDA Recognizes Bone Marrow As The Best Source For Stem Cells….
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.
There have been 9 civil lawsuits (at least) filed against doctors and clinics in the USA!
These clinics and providers that are being sued all have a few things in common…..
#1 they all use either adipose or blood as a supposed source of stem cells
#2 they all were injecting IV or into the eye (in the case of US Stem Cell)
All of the clinics are basically being sued for fraud, misrepresentation, malpractice, amongst other things generally associated with unethical business practices
https://www.nature.com/articles/s41536--6/tables/1
Another Example of Adipose Tissue Tissue Used In Violation Of FDA Regulations
Dr. Joel Singer is a plastic surgeon affiliated with the Cell Surgical Network, who has publicly announced he has treated NFL player(s) with IV adipose tissue for concussions or other neurologic disorders. According to the FDA guidelines, adipose tissue digested to make SVF or made into smaller adipose tissue pieces broken down by mechanical disruption is a biologic drug. Biologic drugs need to be registered and go thru a well defined and expensive and time consuming FDA process BEFORE being approved for human use. Dr. Singer doesn’t have an Investigational Drug License or a BLA on file with the FDA so apparently, according to the FDA…he is using and promoting an unapproved biologic drug.
We only use minimally manipulated bone marrow derived stem cells because that is allowed by the FDA for homologous uses…We can’t sultry or store or bank the stem cells. According to there best legal opinions we have today, using bone marrow for orthopedic applications….a practice done for the past 100 years in various ways……is currently not regulated by the FDA.
https://www.medpagetoday.com/neurology/headtrauma/70921
FDA issues warning letter to US Stem Cell/Kristin Comella Over Advertising and Using Adipose SVF for Stem Cells
Today the FDA issued a warning letter (http://bit.ly/fdausstemcell) to US Stem Cell and their Chief Scientific Officer, Kristin Comella, giving them 15 days to stop their current practice of using stromal vascular fraction (adipose tissue) for multiple medical conditions. The FDA was very clear in its position statement that it considers making SVF from adipose tissue to be a violation of at least 3 aspects of the current FDA guidelines and therefore is considering making a biological drug….which is not approved by the FDA. Be sure to ask the source of stem cells if you see a clinician for consultation! If they say they are using amniotic fluid or umbilical cord blood or adipose tissue (especially SVF) you should strongly consider seeing a clinic that uses bone marrow instead…..since this is the one source of those mentioned that is not being shut down by the FDA and meets all of their criteria as a stem cell source. We have only used bone marrow as our stem cell source from day 1!