Through the recent establishment of a positive “dose-response curve,” which I will explain below, we are one step closer to a cure for these neurocognitive disorders. This is the latest step on an amazing treatment journey that is being written in real-time before our eyes.
Duration of Benefit:
I have written of our stunning success in partially reversing Parkinson’s Disease, ALS, Lewy Body Dementia, and Alzheimer’s with exosomes derived from stem cells. This is an apparent disease-modifying benefit that has never before been reported. Results have been enduring for PD for many months, a little less so for LBD, and much less so for ALS.
Repeat Treatment:
Repeat treatment has produced further benefit in patients who responded to the initial treatment.
But If Some is Good, Is More Better?
This was the next step to be investigated.
In our trip to Antigua last week where we performed our treatments, we performed repeat treatment on several patients who had shown improvement but were still quite significantly affected. Until now we had provided the same dose to each patient - which was extrapolated from the dose which had produced results in mice and rats.
However, this time we performed treatment on consecutive days, 800 billion exosomes Friday and then 800 billion more exosomes Saturday, for a number of patients to see if the benefits would be greater by doing so. We found that patients had significant benefit from their Friday 800 billion exosomes treatment but then even further benefit after their additional 800 billion exosomes on Saturday. And their final status after the Saturday treatment had them at a higher level than they were at after their single-day treatment at their prior visit to Antigua.
This greater benefit from a higher dose, 1.6 trillion exosomes compared to the 800 billion exosomes is called a positive “dose-response curve.” It might seem obvious that this would occur, but it is not always the case. For example, in our systematic review of stem cell treatment for knee osteoarthritis, it was not clear that more was better above a certain threshold.
The significance of this relationship being present here is that it raises the possibility that further incrementally increasing the dose will provide even greater benefit – all without eliciting any side effects or serious adverse events. We have already had one Parkinson’s patient whose subsequent treatment eliminated essentially all his symptoms. We intend to keep incrementally increasing the dose in other patients to explore how much greater benefit can be obtained and observe to make certain that no adverse events occur. We think there is considerable room to increase the dose based on some mouse studies where much greater doses were given with complete safety.
And this also means that there is a possibility that further increases in dose may have the potential to eradicate the disease altogether – although even if this does occur it is likely that booster treatments will be necessary to maintain it. However, for a quick, painless procedure without side effects, this should not be problematic.
The Future:
This finding also means that the more potent exosomes that are now being engineered are likely to produce significant benefit with smaller and less frequent treatment. And we are also hopeful that these more potent exosomes will produce more frequent success in areas, such as hearing and retinal disease, where we have had some success but much less frequently than the very high response rates seen in Parkinson’s disease, ALS, Lewy Body Dementia and to a lesser extent Alzheimer’s disease.