Question: Should a small Orthobiologic animal study immediately result in a mass produced biologic drug for humans? Answer: hmmmm.
Video #14 in the “Know Series” of most common Prp and Stem Cell and orthobiologic questions we get from Doctors and patients and salespeople.
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.
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.