Right now, we know that PRP is not overseen by the FDA as it is neither a drug nor a minimal manipulation therapy. We know that the FDA frowns upon the use of medicinal signaling cells, and exosomes unless they are part of trial. We know that the FDA has approved several research protocols at various centers to use signaling cells. Some centers are approved in select applications to use regen med outside of research protocols.
None of the regenerative medicine procedures are FDA approved. We are all waiting to hear from the FDA. In October of 2020, they are supposed to publish a set of recommendations and guidance for regen med practitioners.
So, PRP is considered outside of the purview of the FDA. Other biologics are not approved.
Right now, harvesting signaling cells from you and then re-inserting them back into you is considered part of same surgery exemption and is allowed under FDA 361 approval pathway.
So, with all the gray areas in regulation, which treatment should you choose?
The treatment in which there is the most experience is PRP. It is believed to work for around nine months. If a patient achieves 70% reduction in pain, after multiple treatments, that is considered success. Exosomes in the plasma as well as exosomes and other signaling bioactive substances released from the platelets are the likely factors involved in treatment success
Exosomes are probably a major contributor in signaling your body to regenerate. So, why not simply treat with extremely potent exosomes derived from donated afterbirth related materials? It makes intuitive sense and seems to be producing results. The fad approves exosomes as a treatment only if enrolled in a trial. One of the fundamental questions with exosomes is……do the afterbirth signaling packets have the right stuff? Do they have the right signals to tell your body to regenerate? Are the signaling packets that were used to create new life the same ones that are needed to create new tissues in you? We don’t know. The early studies suggest that this is the case. But we do not have enough data.
Medicinal signaling cells probably function by supplying your body with the tools to regenerate. It is unlikely that they are true transplants and take up residence in your body and therefore regenerate your tissues. More likely is that they have the right stuff (genetic information and signaling)(growth factors)(signaling molecules) to turn your body into a local tissue regenerator.
So which one to choose? Experts in the filed believe that the effects of exosomes may be temporary and that stem cells may have a longer lasting effect. Which will result in more regeneration? We don’t know. Prp has the lowest presumed potency of the three choices, but this is not proven. Exosomes may be the holy grail as some believe, but we just do not know.
Some evidence suggests that a combination of the three may be best. My recommendation is as follows: If you want a one and done treatment, consider exosomes or signaling cells from your own body. If you don’t mind two or three treatments, choose PRP. Prp costs much less than other treatments, so, until the data is firmly established, the most rational approach may be to start with PRP and see if you get the results you want.