As many of you know, one of the most promising areas in Regenerative Medicine is the therapeutic use of stem cells. In the United States, we have been limited by regulation of their use, and we have been dependent upon medical research performed in other countries for information regarding best use and protocols for stem cells. In addition, treatments using stem cells are severely restricted in the United States forcing many who need or could benefit from their use to be forced to travel outside the United States for treatment. Finally, things are changing…
First, American Cryostem (listed as “CRYO” on Nasdaq), has recently received approval of its IND (“Investigational New Drug”) application for use of stem cells in the treatment of Post-Concussion Syndrome. I will be participating as a sub-investigator in the Phase I clinical trial directed by the Dr’s. Peter Hanson and Tal David as we use stem cells derived from one’s own fat (autologous, adipose-derived mesenchymal stem cells) to treat Post-Concussion Syndrome (PCS). We are currently recruiting patients with PCS to volunteer to be treated at no cost to them.
American Cryostem, in collaboration with BioSolutions Clinical Research Center, is conducting a groundbreaking study in the San Diego area and is looking to enroll patients with Post-Concussion Syndrome (PCS) also known as Chronic Concussive Syndrome (CCS).
This FDA approved clinical study uses regenerative cells from adipose tissue collected by liposuction from the patient. These regenerative cells or stem cells are the patient’s own regenerative cells and will be given back to the patient through a single intravenous infusion. After the infusion you will continue to be monitored for several months to ensure your safety and monitor your symptoms for improvement.
To participate, you must be between the ages of 18 and 65, have a confirmed diagnosis of PCS or CCS with some persistent symptoms, such as headaches, dizziness, insomnia, impaired memory, intolerance to noise, unusual emotional reactions, and other symptoms. You must pass a screening visit to qualify.
Benefits from your participation are not guaranteed; however, you could potentially experience improved function and decreased symptoms related to your post-concussive symptoms, which could improve your overall quality of life.
Participation will include study exams, laboratory tests, MRIs, liposuction, and a single infusion, all at no cost to study participants. Compensation for your time and travel is provided.
If you have questions or are interested in being a potential candidate for the trial, please submit your contact information below and a research team member will contact you about our study.
Second, American Cryostem recently signed a Cooperative Research and Development Agreement (CRADA) with the United States government to study the use of “Stem Cells for Regeneration and Medical Innovation”. This collaborative work will include the use of multiple types and sources of stem cells to treat a wide array of disease states and pathologies including COVID-19. Stem cells used in the CRADA will be obtained from both American Cryostem and BioTherapeutics Labs, a company co-founded by me and by CEO of American Cryostem, John Arnone, and Sandy Lipkins, the CEO of Biotherapeutics Labs who has been involved with Compliance and Quality Control of stem cells for over twenty years.
The result of these efforts will establish and document treatment protocols for use of stem cells in the United States while raising the bar for stem cell use with unmatched standards and testing for quality, safety, purity and composition above standards established per current FDA requirements and regulation, the American Association of Tissue Banks (AATB), and Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR Part 493.
What does all this mean for you?
If you are suffering from degenerative conditions that formerly were untreatable with stem cells either because travel outside the United States for treatment was not an option or obtaining verifiably qualified stem cells was not available, you now have options for using stem cells and more conveniently and affordably than ever. And, this area of medicine should only be getting better.
Many have been asking about the newly released COVID-19 vaccinations that use mRNA to initiate development of immunity to the SARS-CoV-2 virus. The following has been and still is my response from back in November:
“At the risk of dashing some hope and despite the stock market uptick therefrom, a quick word about the vaccines for SARS-CoV-2 created by Pfizer/BioNTech and Moderna. While I am not a virologist or microbiologist, some basic knowledge of both is sufficient to preclude indiscriminately administering either of the mRNA vaccines. (In fact, I received an email from an orthopedic surgeon who highlighted the same issues two other colleagues and I had been discussing, and, he went even further to elucidate potential issues with genetically modified mRNA).
In short, while spike proteins are released from the inoculated cells, some will remain on the myocyte (and other cells where these spike proteins will migrate) surface (where spike proteins reside). This creates at least potential, but likely probable, development of autoimmunity, exacerbated by the need for two injections annually.
Further, anyone who tells you that a vaccine’s safety can be evaluated without significant passage of time (so that everyone in a vaccine trial has “the chance” to be exposed to the virus, e.g.) is simply wrong. (We COULD overcome this hurdle by purposefully exposing everyone in the trial to the virus, but ethical considerations prevent this). And, even once we have sufficient statistical evidence of exposure and efficacy (which at this point, by the way, neither study is even close to having) we will still be lacking side effect data that requires a longer term and is relatively open-ended in testing any vaccine (will a side effect appear initially or 20 years from now?).
Only if your risk of dying from SARS -CoV-2 infection is high should you consider either of these vaccines, therefore.
Please don’t shoot the messenger.”
Since November we have gathered more data about the “Infection Fatality Rate” (IFR) with COVID-19. Considered one of the most respected epidemiologists in the world, Dr. John Ioannidis, performed a meta-study that shows that not only is the worst case IFR approximately 0.57%, in the United States, approximately 40% of the these deaths are of residents in nursing homes. And, the next highest percentage of deaths is in those over 70 years old. Dr. Ioannidis also points out that these rates differ by area, but using the worst-case scenario average, we can see that the IFR for COVID-19 is far less than initially stated. So, while no one wants to suffer through a COVID-19 infection, the risk of dying certainly is relatively low for anyone who is not in the aforementioned categories or high-risk categories with worse expected outcomes such as uncontrolled diabetes or obesity with fatty liver. It should also be noted that, in children, the IFR is higher for seasonal flu than for COVID-19. And, while the need for time to pass still exists in order to more thoroughly evaluate the safety of ANY vaccine, there are some other vaccine options that make use of other previously used methods for initiating a protective immune response.
While there are many potential candidates from which to choose being developed, in the United States, our choices beyond the Pfizer/BioNTech and Moderna vaccines are likely limited to the following:
AstraZeneca/University of Oxford – this is a “viral vector” vaccine that uses a modified version of a chimpanzee adenovirus to carry DNA into an inoculated patient’s cells which then reacts by creating spike proteins from SARS-CoV-2 which, when presented to the surface and outside of the infected cell, activate the patient’s immune system without causing disease.
Johnson & Johnson/Janssen – this is also a “viral vector” vaccine that uses an adenovirus, serotype 26 (“AD26”) to carry DNA into an inoculated patient’s cells which then reacts by creating spike proteins from SARS-CoV-2 which, when presented to the surface and outside of the infected cell, activate the patient’s immune system without causing disease.
Novavax – this is a “protein subunit” vaccine that uses nanoparticle technology to create antigens resembling the spike proteins from SARS-CoV-2. The SARS-CoV-2 spike proteins assemble into nanoparticles and are combined with a compound made from soapbark, a saponin, “QS-21”, (from the tree more officially called Quillaja Saponaria) which helps to engender a strong immune response. Similarly to an attenuated virus, the manufactured immunogenic nanoparticle activates the inoculated patient’s immune system without causing disease.
This is perhaps the most interesting of the vaccines created for a number of reasons. The antigens (spike proteins) are delivered directly through the inoculation rather than having to be created by the inoculated patient’s cells. This would eliminate the potential mentioned above for development of autoimmunity to a cell producing and presenting with spike proteins. The virus, called baculovirus, used to produce the proteins needed for the SARS-CoV-2 vaccine is not, in and of itself, in any form, dangerous to humans, and has been used for over 30 years in the production of other vaccines such as annual “flu shots” and in gene editing therapies. It is currently being used to develop several other vaccines to protect against HIV, HPV, Herpes Simplex, Ebola and many other viruses presenting a significant threat to humans. And, development of a fully functional vaccine is possible with in 45 days using baculoviruses.
When requesting refills via the Charm Portal, please remember to include the quantity of the medication or supplement you are requesting, the address to which you would like items sent, the delivery method(“Overnight” or “2-Day”), whether signature is required for delivery, and the last four digits of your credit card that you would like charged.
We suggest and request that you require signature for delivery, if possible. Please note that if you choose not to require signature for delivery, neither we nor the pharmacy can assume liability if your package is lost or stolen.
Please remember that the time between refill request and delivery includes our office and pharmacy processing time as well as delivery time.
The “Standard of Care” in the practice of medicine requires periodic consultations and evaluations in order for medical practitioners to prescribe medication to patients. With prescriptions of Controlled Substances (e.g., testosterone), annual visits are required for patients who have been seen in the office, and semi-annual visits are required for telemedicine patients. Laboratory assays must be included in the evaluation once per year. I would hasten to add that, whether legally imposed or not, a minimum of an annual consultation is simply good medical practice. Please understand and plan visits accordingly to enable us to continue to prescribe medications without interruption to your therapy. (We strive not to be pestering, but send email reminders to help).
Questions for your Provider
One of the issues we try hard to avoid is a lack in communication between Medical Provider and Patient. The “standard” method of communication through periodic appointments is useful certainly, but is not always the most convenient or practical, and can often – unfortunately – lead to patients’ “practicing medicine without a license” 🙂 – making decisions that would likely be better made with information and guidance from one’s Medical Provider. PLEASE consider making use of the messaging system provided within the PHR Portal within Charm for those occasional (any) questions that may arise during the course of therapy. Certainly, we are not trying to discourage you from making an appointment for consultation if there is an issue or concern that may require more than a simple answer, but for those more simple, less complex issues or questions, please make use of this easy method of communication.
Getting healthy food at home safely
While some of you have begun venturing back out to restaurants, whether it is to collect “take-out” food or to actually “dine-in” under the latest guidelines, there has been an upswing in use of meal preparation services as an alternative, and I have been asked about their safety, quality, and, of course, taste.
In general, food prepared by meal delivery services should be equally as safe as that prepared in restaurants. The same regulations regarding safety from food storage, food preparation areas, and food preparers and deliverers health apply. Food delivery quality is variable depending upon the service just like it is dependent upon the restaurant.
Given the recent inquiries and our current pandemic, I’d like to share how I found the only food delivery service I recommend: Z.E.N. Foods.
On my one and only trip on a G4 jet, I was offered a selection of meals from which to choose my lunch for the flight to the Cayman Islands to help design a Medical Resort. After tasting and then devouring every bit of every selection on my plate, I asked the principle who organized the group from where he had catered the inflight meal. He replied, “from the two behind you, Marianna and Kane – they are handling the design and implementation of all the foods offered at the medical resort”. Suffice to say that that was the beginning of a long relationship that also led to my recommending ZEN Foods to my patients as a distinct alternative to the meal plans and delivery services that asked one to stomach newly mown lawn with red wine vinegar on top as their salad offering as part of their “healthy weight loss” option. I believe that one of the last things needed or desired when restricting calories is to eat tasteless food.
Many of you already know about Z.E.N. Foods from having inquired about easy ways to adopt a diet adjusted specifically toward your goals. This is just a reminder to those, and potentially a service to others, who need or would like options for themselves and family during the stay-at-home period. To be clear, I must say I have no financial interest in ZEN, but I do share my medical advice as a Medical Advisory Board member, and feel I benefit indirectly in being able to recommend them to happy consumers.
More about Z.E.N. Foods:
Z.E.N. Foods (Z.E.N. stands for “Zero Effort Nutrition”) prepares an always savory variety of healthy meals and delivers them to your door fresh daily, so you don’t have to leave your home to enjoy chef-prepared, nutritionally-balanced meals. Perhaps more importantly now, Z.E.N. Foods follows the most rigorous food safety guidelines in the industry with strict protocols in place to ensure your meals are safe:
- Strictly enforced food safety guidelines including frequent hand washing, gloved hands and full protective chef coats, safety masks, and hairnets.
- Surfaces are sanitized and gloves are changed between duties to prevent any cross-contamination.
- After food is prepared cooked, all meals are blast chilled to 34°F, then plated and packaged at the same temperature to prevent food-borne illnesses and to ensure freshness.
- Cooler bags and ice packs use to transport meals are sanitized and disinfected daily.
- A zip tie is applied to cooler bags as a lock to prevent tampering.
The team at ZEN Foods will also give a 10% discount to anyone who mentions that they heard about them through RSM.
You can reach them at 310.205.9368 and see more on their website:
For more information about Z.E.N. Foods’ home meal delivery plans: https://zenfoods.com.
For more details on how Z.E.N. Foods is addressing COVID-19: https://zenfoods.com/learn-more