Heretofore there has been no effective treatment for Parkinson’s disease - except replacing dopamine with L Dopa - nor for Alzheimer’s, nor essential tremor - which often leads to PD and dementia. While essential tremors can be helped by Beta blockers, they do not eliminate it and they have side effects. There is no effective treatment for hearing loss. Below I will describe our exciting early results using intra-nasal exosomes (which are tiny vesicles secreted from stem cells) where we have some evidence of helping all these problems. This is the first human data of its type of which we are aware.
CLINICAL TRIAL: We are infusing mesenchymal (NOT embryonic or fetal) stem cell-derived exosomes intranasally in a clinical trial for Parkinson’s disease, early/moderate Alzheimer’s, essential tremor, ALS, MS, autism, hearing loss, retinal disease, and related brain/CNS disorders. The exosomes come from Vitro Biopharma from which we obtain our stem cells: their cells and exosomes are approved by the US FDA for use in human patients. As part of our clinical trial, we are offering treatment at no charge in Athens June 17th-23rd and Antigua in August, and previously in May, for the phase 1 stage of the trial now ongoing. The phase 2 trial will have a charge to be determined where we have evidence of efficacy from the phase 1 trial. We have treated twice in Antigua and will be treating in Athens next week. We have had very exciting early results as follows:
INTRA-NASAL: Many pre-clinical (animal) studies have shown efficacy from intra-nasal exosome treatment for neurodegenerative disorders. They have also shown higher exosome brain levels from intra-nasal infusion in comparison to intravenous infusion. This route bypasses the blood-brain barrier by allowing transport of the exosomes along the olfactory/trigeminal nerves directly into the brain through the cribriform plate at the top of the interior of the nasal passages. Pre-clinical studies, and now our own experience in human patients (see below), have shown benefit from intra-nasal exosomes where benefit is not obtained with intravenous stem cells.
The intra-nasal infusion is painless, there are no needles. It takes about 15 minutes using a special (Tian) syringe that pain specialists use to inject the sphenopalatine ganglion. The injections are performed either by myself or a pain specialist medical doctor. We infuse 800 billion exosomes per patient. 4cc in each nostril.
Results of Human Treatment So Far
PARKINSON’S DISEASE: 2 of 2 patients with moderate PD treated with 800 billion exosomes had modest but clinically significant benefit within 8 hours: improved gait, fluidity of speech, and decreased mask-like facies. Increased theta waves from the parasympathetic nervous system on EEG were seen the next day (correlates with anti-aging) in the one patient tested before and after. Results have been maintained almost one month after treatment. No drug exists currently for PD except for replacing dopamine. We believe this is a potentially game-changing remedy. The only other patient treated was treated earlier with a smaller dose and did not respond but has been offered re-treatment with the higher dose again at no charge.
ALZHEIMER’S: 2 of 2 patients with mild to moderate Alzheimer’s had noticeably improved mental acuity, in less than a day, continuing to improve 3 weeks later in one patient.
ESSENTIAL TREMOR: 80% or more eliminated in three patients.
HEARING LOSS: 1 of 1 with noticeable improvement beginning 2.5 weeks later, maintained after four weeks.
MULTIPLE SCLEROSIS (MS): 1 patient treated with no improvement so far one month later.
ALS: None treated. We are looking for a patient to treat based on animal studies showing benefit in a pre-clinical ALS animal model.
EYE: PRESBYOPIA: 1 patient – whom we were not intentionally treating for an eye disorder who was being treated for tremor – noticed 3.5 weeks later that she no longer needed her reading glasses, nor to make the print bigger on the computer. This clearly shows the exosomes are getting into the eye. We are in the process of scheduling at no charge several patients with retinal disease. We believe it is likely it will help.
The Future
Technology exists to concentrate the exosomes tenfold which may produce better results; also to produce more specialized neural cells with more potent exosomes. This requires investment from Vitro Biopharma, which they are looking to pursue. We hope to have these even stronger treatments within 6 months to one year. We are looking forward to seeing if beneficial results can be obtained in autism, retinal disease, stroke, and even ALS. We do not know what we will find, but our research foundation is committed to further trials to find out. - and help more people with these otherwise difficult or impossible-to-treat disorders. Because exosomes are less expensive than stem cells, repeat treatment if needed will be easier. We also hope to obtain funding for an FDA trial for these disorders and others. If successful this would allow treatment in the United States, and hopefully eventually, insurance reimbursement. In the meantime, though we are excited to be helping. We will learn much more in the near future as we treat more patients.