A few thoughts from running this by a well-informed MD, though I think most of these probably have already been discussed in some depth one way or the other either in this thread or over on MPP.
- would the patent office consider this a drug and kick it over to the FDA?
- why would someone even seek a patent in the first place on autologous PRP? Is the PRP prepared in a unique way different than how the many others already preparing PRP are doing it?
- the pure tone audiometry improvements seem fairly modest. But if they are statistically significant, even modest improvements are welcome. But, seems unclear if the changes were lasting?
- PRP conceivably might help partially damaged hair cells via growth factors, but seems unclear how it could result in further regeneration of the auditory nerve?
- unclear if patients received dexamethasone, if they did that may account for improvements?
- are the tinnitus improvements quantified and documented in some way?
Perhaps for those Skyping with Dr. Minbo Shim, some questions that could be added to the list.
I'm just trying to answer a bit with conjecture. I believe that the PRP being prepared a unique way is most of what is going on here. The patent describes viscosity that is moving slowly and able to touch anatomy for longer amounts of time. Also, I believe he uses some stem cell as well as vitamins and like you said possibly dexamethasone in combination. I'm not sure if it counts that he had an option for IV treatment listed as well. So whatever his cocktail is, I believe that is thought to be unique. Although it seemed like there were many possibilities as to what the treatment could have been, anywhere from the quantity, frequency, and composition of the treatment. If what I am saying is accurate, I would be very curious to know if/how he tailors the treatment to the individual.
He has said that some of the treatment results reverted and were not lasting in response to our small community Skype questionaire.
If the PRP could repair hair cells, but potentially not the auditory nerve, would the patient still have improvement of hearing? Many of us have only damaged hair cells and not nerve damage, correct? Or does it almost always correlate?
"Since PRP having a high viscosity is slowly discharged from the ear, the PRP may contact nerve cells in the inner ear for a long time. The nerve cells in the inner ear may be regenerated by the PRP."
It seems to me that the ideal candidates for this treatment would be similar to those for LLLT; near time of injury, hyperacusis, damaged and not dead cells, and therefore minimal hearing loss. I would say high frequency damage is a candidate since it is often the first to be damaged, but we still have anomalies with the HF results from this treatment. There is potential for HF damage with this treatment, and it is unclear why. I believe he sad that more treatment was the resolution for this?
@Artemis2K, could you confirm?