MSC Exosome Therapy FAQ | Safety and Compliance
WHERE DO YOUR EXOSOMES COME FROM?
Our manufacturer harvests our exosomes from Wharton’s Jelly found in the umbilical cord of a new birth and extracts the mesenchymal stem cells. The umbilical cord tissues are obtained from healthy, consenting donors who are under the age of 35 who have been thoroughly screened, and who are undergoing a scheduled c-section. This allows us to use the newest and most potent stem cells / exosomes possible.
ARE MSC EXOSOMES SAFE?
Absolutely! Exosomes in general are safe and don't have any negative side effects. The only issue that could come up is how the exosomes are extracted and handled. Our exosomes are manufactured in accordance with the strictest Current Good Manufacturing Practice (cGMP) standards. Our exosomes are carefully sourced and processed to ensure the highest quality and efficacy. Furthermore, our manufacturer performed safety studies, injecting participants with 1,000 times the normal dosage 3 times per week for 30 days. There were zero side effects and they found that the excess exosomes were discarded in the participant's urine.
We extensively evaluated the different exosome labs and manufacturers and chose the one that stood out among all the others. Our exosomes are the only ones legally permitted to be sold and used for research and investigational use. Unlike the others, our manufacturer provides a Certificate of Analysis (test results) with every order so we know the exact contents of the product we are treating you with and that it is sterile and safe.
WHAT’S THE DIFFERENCE BETWEEN STEM CELLS and EXOSOMES?
Stem cells are a special type of cell found in the body. They’re unique because they can become many types of cells and act as both building blocks and repair mechanisms in your body.
Exosomes are extracellular vesicles, which is the medical term for tiny bubbles that are released from stem cells when there is inflammation in your body. Exosomes carry genetic information and proteins to cells throughout your body, and they create paths for communication between cells. MSC exosomes are known to be 7 times more potent than stem cells.
When you are born, you have fresh and healthy stem cells. Your stem cells secrete exosomes when you have damaged cells from an injury, virus, disease, or anything abnormal happening in your body. The exosomes travel to the affected area and begin the regeneration process. The exosomes we use are harvested from Wharton’s Jelly, which has the most potent and abundant stem cells you can find. The exosomes are separated from the stem cell, extensively tested, diluted with saline, and bottled up, resulting in the purest and most potent MSC Exosomes on the market today. Our product has a minimum of 20 Billion Exosomes per mL and over 700 Growth Factors.
ARE EXOSOMES FDA APPROVED?
At this time, the FDA has not officially approved any exosome products. The reason for this is that unlike other drugs on the market that treat a specific condition, Our MSC exosomes are capable of regenerating a multitude of medical conditions. Our manufacturer has 13 clinical studies in process as of today and adding new studies all the time. Given each individual study is successful, the FDA will approve our exosomes for that specific medical treatment. However, it’s been stated that our exosomes are in fact safe because they are cell-free and do not contain any DNA. The only issue that has been reported is when a manufacturer didn’t properly sterilize the product or if the provider contaminated the syringe during administration.
WILL MY INSURANCE PAY FOR THE PROCEDURE?
Insurance carriers won’t cover the cost of exosome therapy until they are FDA-approved for specific medical conditions. Some insurance carriers who underwrite policies for the NFL, NBA, and NHL have written a specific policy and will cover the cost when using our exosomes only. Unless you are covered under the policy with those professional sports organizations exosome therapy is a cash pay procedure.
HOW DO MSC EXOSOMES COMPARE TO PLATELET-RICH PLASMA (PRP) TREATMENTS?
Exosome treatments are considered 100x MORE effective than PRP. PRP treatments require a blood draw which can be unpleasant for some people. The purpose of drawing your blood is so we can spin it and separate the platelets that contain growth factors. However, PRP has been found to be inferior to exosome therapy for many reasons the most notable being that you can typically get just 7 and 25 total growth factors from PRP and our MSC exosomes have over 700 growth factors. Also, PRP does not have any anti-inflammatory properties where exosomes do. Furthermore, the older you are the less effective PRP will be. With exosomes, age does not matter.