Here is a summary of how the Exosomes are obtained.
In the USA, tissue acquisition companies obtain consent from mothers undergoing a scheduled c-section. Ethicists have determined the donors are not allowed to be paid. The mothers complete a 210-question packet, which eliminates over half of the potential donors. Questions about risk factors, recent travel, smoking, medical conditions, etc. are asked. If the mother is accepted, the birth tissue is collected into a sterile container in the operating room. Remember, if the tissue isn’t donated, it’s typically discarded so there are no ethical issues for donation. The tissue is then transported directly to the tissue processing lab. The processing of the tissue is performed in clean rooms that are ISO Certified. Once completed, several samples are sent to a third party for disease and sterility testing. The biologics are kept in quarantine freezer until all the quality control testing returns negative. If anything is positive, ALL the biologics are discarded to ensure patient safety. The biologics are kept at frozen until just prior to administration. Testing of batches continually shows purity, potency and effectiveness. This is of utmost importance to ensure patient outcomes, trust and integrity.
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