Heretofore there has been no effective treatment for Parkinson’s disease - except replacing dopamine with L Dopa: which has onerous side effects including the untreatable movement disorder tardive dyskinesia. There has also been no effective treatment for Alzheimer’s or Lewy body dementia, nor essential tremor - which often leads to PD and dementia. While essential tremor can be helped by Beta blockers, they do not eliminate it and they have side effects. There is also no effective treatment for hearing loss or tinnitus.
Below I will describe our exciting early results using exosomes (which are tiny vesicles secreted from stem cells) with which we have evidence of helping all of these problems. This is the first human data of its type of which we are aware.
PRE-CLINICAL TRIALS
Extensive animal testing has shown substantial evidence of efficacy from exosomes. Notably there has been a complete absence of serious adverse events. Based on these promising animal studies we obtained IRB approval for human clinical trials.
CLINICAL TRIAL
We are infusing mesenchymal (NOT Embryonic or fetal) stem cell derived exosomes in a clinical trial for Parkinson’s disease, Lewy Body Dementia, Alzheimer’s, essential tremor, ALS, MS, autism, hearing loss, retinal disease, spinal cord injury and related brain/CNS disorders. The exosomes come from Vitro Biopharma from which we also obtain our stem cells: Their cells have been repeatedly approved by the US FDA for use in human patients. The clinical trial is IRB (institutional Review Board) approved. The initial cohort of patients were treated at no charge. Subsequent patients are being charged a modest fee, where efficacy has been preliminarily established.
I am herein describing our early results 6 months into the trial. We have treated varying numbers of patients qualifying for the various studies. However our early results for some of the disorders are so striking I wanted to present them here.
PARKINSON’S DISEASE (PD): Seven patients qualified for the study and have been treated. Follow up varies from 2 to 4 months far. All patients had moderate PD. All treated patients treated obtained substantial rapid improvement – incredibly within 8 hours in most. In all but one patient the benefit has been enduring at 2 – 4 months follow-up. One patient so far has obtained repeat treatment with further significant benefit. Improved gait, balance, fluidity of speech, decreased mask like facies, loss of dysgraphia (ie restored ability to write) and improved mood are some of the benefits seen.
EEG TESTING: Increased theta waves, “calmness waves” characteristically seen in younger patients from the parasympathetic nervous system, were seen after treatment in all patients tested.
CONCLUSION: While results are early, the consistency of benefit and the duration of benefit indicates that this is likely to be a game changing remedy for PD.
LEWY BODY DEMENTIA: This disease may be worse than Alzheimer’s because it produces debilitating movement problems in addition to dementia. Only one patient has been treated so far. However the patient had dramatic improvement in cognition, motor, balance, and even loss of nightly medication induced nightmares. Cognitive benefit has been maintained for 2 months. There has been minor loss of motor movement, but the patient is still markedly improved compared to pre-treatment state. This patient will receive a second treatment in November 2024. Two other patients are scheduled for treatment.
HEARING LOSS/TINNITUS : Substantial improvement has been seen. One patient had a post treatment audiogram which showed substantial mid and high range improvement on post treatment audiogram as compared to pre-treatment. One patient with chronic severe tinnitus had almost complete elimination of the tinnitus after eight years of suffering.
ESSENTIAL TREMOR: Excellent results in all treated patients
PRESBYOPIA/AGE RELATED FAR-SIGHTEDNESS: Good improvement in several patients
RECRUITING PATIENTS FOR OTHER DISORDERS: In addition to the patients treated with the above diagnoses we are expanding our diagnoses treated to certain other central nervous system disorders. To that end we are recruiting patients for treatment at no charge for ALS, Spinal cord injury, stroke, seizure disorder and MS. Any interested patients should e mail care@thepsci.com with their diagnosis and a representative will contact them to see if they qualify.
THE FUTURE
Our treatment substance is actually the “secretome” of the stem cells. That is, it includes exosomes but also growth factors. Technology exists to concentrate the exosomes tenfold which may produce better results: also to produce more specialized neural cells with more potent exosomes. We hope to have these even stronger treatments available within 6 months to one year. Benefit so far is unprecedented as described above. We expect these newer formulations to produce even better results going forward for these heretofore untreatable disorders through further clinical trials. Because exosomes are less expensive than stem cells, repeat treatment, if needed, will be easier. We also hope to obtain funding for FDA trials for these disorders and others. If successful this would allow treatment in the United States, and hopefully eventually, insurance reimbursement.
About Dr. Chadwick Prodromos
Chadwick C Prodromos, M.D. is the Medical Director and CEO of The Prodromos Stem Cell Institute and also Medical Director of the Foundation for Orthopedics and Regenerative Medicine. Dr. Chadwick Prodromos is a global leader in the use of advanced therapies, including stem cell and platelet-rich plasma, for the treatment of a wide range of diseases and has done extensive research in these areas.
Dr. Prodromos obtained his Bachelor's degree with honors from Princeton University and his MD degree education from the Johns Hopkins Medical School. He served a surgical internship at the University of Chicago, after which he completed his residency training in Orthopedic Surgery at Rush University. He obtained a fellowship in Orthopedics and Sports medicine at the Harvard Medical School and Massachusetts General Hospital. Board Certified in Orthopedic Surgery, Dr. Prodromos served as an assistant professor of Orthopedic Surgery at Rush University for nearly three decades and has extensive publications and research in both orthopedics and stem cell treatment.
To learn more about stem cell treatment options and stay informed about the latest advances in the field, please visit www.stemcellcouncil.com. If you're considering stem cell therapy and would like a free quote, visit www.stemcellcouncil.com/free-quote to get started on your journey toward better health and improved quality of life
