Question: Should a small Orthobiologic animal study immediately result in a mass produced biologic drug for humans? Answer: hmmmm.
* 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!
Have Exosomes been shown to work in humans for orthopedics? Ummmm, NO!
One of the latest fads in regenerative medicine is to sell doctors and patients on “exosomes”.
Exosomes are the little “containers” that cells produce and they can contain cytokines, growth factors, proteins, and even genetic material.
1st problem: Cells produce exosomes and their contents in response to their local surroundings….so if a cell is in an inflammatory joint….it will produce the correct exosomes and release them to try to stimulate a healing response. So…..how can a company produce a “one size fits all” bottle of exosomes? They can’t.
Second problem: Exosomes are almost certainly considered a biologic drug by the FDA. Why? because they are made in a laboratory as a byproduct of culturing stem cells and the FDA has already ruled that the process of culturing stem cells is considered drug making. Additionally, any allograft (not from your own body) injection that can transfer genetic material has typically been considered a biologic drug by the FDA….requiring many years of study and carefully controlled experiments before being approved by the FDA for sale and use in humans. Have any exosome makers done this? Nope, not one!
Third problem: Show me the science…..So, how many human outcome studies have been published showing that the use of exosomes results in a better clinical outcome in humans…for any orthopedic conditions? NONE, ZIP
If and when an exosome ever gets published we will be all “ears and eyes” to see the results of using exosomes compared to the Platelet Rich Plasma or even Mesenchymal Stem Cells.
Fourth Problem: The last offer I had to buy 1cc (yes 1cc!) of exosomes was $900! That is the equivalent of spending $3.4 MILLION dollars on a gallon of gas.
My advice, tap the brakes on any clinician offering to treat you with exosomes or on any salesman doing the same…..spend about $2.50 on a gallon of gas and go see a reputable, orthopedic trained MD/DO…..maybe even an orthopedic surgeon who can give you all of your legit options!