The Dallas PRP and Stem Cell Institute/Texas Orthobiologic Institute “Know Series” Video #9. In this short video clip Don Buford, MD answers a surprisingly common question asked by patients…..”Will my knee xrays get better after a stem cell injection” As it turns out, there are many “stem cell” clinics running stem cell seminars at which patients are told that their cartilage will completely regenerate and that their X-rays will get better. This is not proven by any published study in orthopedics and patients should not be told this as a sales ploy.
In this short video clip Don Buford, MD answers a surprisingly common question asked by patients…..”Do I need special massages to make these injections more effective?” As it turns out, there are several local DFW “stem cell” clinics running stem cell seminars at which patients are sold a package that includes massages “….to help regenerate the joint after the injection”
One of the most common questions I get in clinic from prospective patients is about the post procedure rehab and the recovery process. Many patients come to see me because they have been told that their next option is surgery with significant time off of work and other family and recreational activities. Naturally, they want to know how much down time is involved with orthobiologic injections if they are a candidate. The good news? For virtually every clinical condition I treat, the “downtime” after an orthobiologic injection is measured in days instead of weeks or months like it usually is after a surgical procedure
Many unscrupulous regenerative medicine clinics are telling patients that because their clinic is doing a “study”, or sometimes an “IRB study”, their procedures are allowed by the FDA. This is simply not true. Many orthobiologics are regulated by the FDA and if there are claims of stem cells in the product, then the FDA definitely is involved. As we have seen in recent publications, the birth tissue products do not have living functional stem cells when thawed in a doctor’s office in 5 minutes so all of those products tested to date by independent university level researchers have shown no significant stem cells in them! Furthermore, if they DID have stem cells in them, they would still be in violation of FDA regulations because they would be need to be regulated as biologic drugs and none of those companies have applied or paid or done the research necessary to type of regulatory clearance from the FDA. The best advice? Avoid ANY clinic trying to sell you stem cells that are not 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!
https://prpseminar.com/agenda/The TOBI 2019 Regenerative Medicine Course is underway in Chicago!
I had the opportunity to give the first talk on Bone Marrow Aspirate and Concentrate Basic Science.
This course brings together many hundreds of international clinicians all interested in learning the most recent data in the orthobiologic field. The course is also a training course with hands on cadaver labs so attendees can practice bone marrow aspiration, adipose harvesting, etc.
I have been fortunate to be invited to lecture/teach at this course for many years!
Anyone interested in the lecture handout from my talk on
Bone Marrow Aspiration/Concentrate Basic Science can click here:
Goodbye and good riddance to the R3 Stem Cell Chain of over 45 affiliated clinics who were taking advantage of people in pain and with debilitating conditions by selling them stem cell injections that were not properly registered and that were not even stem cell injections in the first place.
FDA just sent another Untitled warning Letter (https://lnkd.in/e4MhAHR) to a “Stem Cell” Organization promoting stem cells from birth tissue products like amniotic fluid and umbilical cord blood for diseases like ALS, diabetes, Parkinsons, Lyme disease, strokes and more. The R3 Stem Cell Clinic (r3stemcell.com) founded by David Greene, MD, MBA has over 45 affiliates nationwide. The FDA letter once again notes that these birth tissue/prenatal products require registration as section 351 products which is NOT the way any of these companies and clinics operate with very very few exceptions. I would hope that this organization will be rolled up and shut down and stopped from treating people as it currently does in violation of FDA regulations.
The company’s founder, David Greene, MD ….used to be an orthopedic surgeon but had his AZ medical license revoked in 2009. I am glad to see that the acting FDA commissioner, Ned Sharpless, MD, is continuing to ramp up FDA enforcement against unscrupulous and in some cases frankly criminal organizations preying on people in pain and with chronic debilitating diseases. #fda #orthobiologics #regenerativemedicine