A lot is changing in the world of cell therapy including, better science, improved clinical outcomes, and an increase in FDA oversight. This has created an environment for rapid growth for many of our Go Wellness and East West Health clinics. I believe that the best way to convert this amazing opportunity into a lasting medical model where our patients are receiving cell therapy 100 years from now is to plug up any leaks on the ship. We have a significant amount of sailing to do and we all need to be very diligent about using the best practices in the field.
How can we have the best practices? I think it comes down to 3 major things:
1. Using cell therapy as part of a holistic treatment program. This is not a “one and done” as we’d like to believe. Our procedures, nutritional guidelines, herbal and hormonal treatments are all heavily designed to leverage the best possible outcomes from the cell treatments.
2. Procuring the right cell product so that your clinical results are maximized. I’m still shocked at the differences in the quality of the tissues, which will influence your results. I’ve spoken to dozens of labs, tested multiple products independently, and have performed the heavy lifting so that you get access to the world’s best cell product that meets the FDA requirements of minimal manipulation.
3. Increase impact of marketing and sales. Many of you aren’t doing either of those very well and it’s time to put 15-20% of your monthly revenue goal into effective marketing. The pharmaceutical companies are spending over 50% of their revenue in marketing and so we’ve got some work to do. You also need to get your entire team trained in handling all of the objections that patients will bring up with receiving cell therapy. We’ve documented hundreds of the most nuanced patient concerns that we’ve resolved over the years and that knowledge gives the entire East West team massive levels of confidence. Once you and your team can handle any objection like a pro, then your marketing and sales will increase 10x.
The quarterly live stem cell training seminars and the online portal were created for you to learn those 3 things. This post will address some exciting findings for addressing why we use Utah Cord Bank over other cell banks, and our upcoming webinars and events will address the other 2 areas that we can grow into.
I recently had Eliott Spencer, Phd. (founder of Utah Cord Bank) on my podcast, Go Wellness Radio, (click this link to view the podcast) and I’ve quoted him several times throughout this email for clarity.
CFU’s Discovered with Minimally Manipulated Cells
Last week, the Utah Cord Bank announced that they have the first ever birth tissue product to have colonizing forming units (CFU’s) in their StemShot and StemVive products. This finding is monumental and couldn’t have arrived at a better time with all of the FDA crack-downs. The CFU assay is one of the most important assays for measuring the vitality of your cryopreserved cell sample. Below is an image of the CFU supplied by the third party testing facility in California, Davinci Bioscience.
I asked Elliot Spencer, Phd. Founder of Utah Cord Bank, why this is important and he responded, “If you’re interested in how the cells are doing and how they’ve survived the processing into a flowable, how they’ve survived freezing and then thawing, flow cytometry alone is not going to give you the same depth of information that you would get from a colony forming assay. For example, within minutes, sometimes hours, sometimes minutes, sometimes seconds of thaw, cells that may appear live on a certain slide on a microscope or through flow cytometer will undergo “apoptosis”.
What is apoptosis? Cells clump together and they’ll go through a programmed cell death, which we call apoptosis.
Many things can trigger apoptosis. This life that we have taken out of its native environment and frozen as carefully as we possible can, we use ray-controlled freezers and well established cryopreservatives, but regardless, this is an incredible shock to these cells and in addition and besides grinding up or whatever you are doing to free them and possibly damaging enzymes, you’re also potentially disrupting cell membranes, transmembrane proteins are often destroyed in these processes, and there are just a variety of things that will lead these cells to either be dead or dying by the time they’re assayed.”
Most companies that are offering birth tissue allographs are using a single compartment like the cord blood, umbilical tissue, placenta decidua or amniotic membrane. I was doing the same until Elliot Spencer’s team from Utah Cord Bank approached me with their birth product that contained all the compartments of the birth waste tissues are used: the placenta decidua, umbilical cord tissue, cord blood, and amniotic membrane. Elliot Spencer’s lab was the first in the country to start banking umbilical cord tissue and I had tested his product and it outperformed all the others that I sent out.
All these compartments are rapidly processed without using enzymes which can pull apart the cells from the tissue but at the same time these enzymes can compromise the scaffolding characteristics that are proven to be effective in rebuilding structures in the body. It is a challenge to take birth waste tissue and put them into a flowable while preserving and maintaining the all the proteins, cells and healing properties needed. The other risk factor is the onset of apoptosis (cell death) from the processing, no matter how high the cell count is at the time of extraction, if they all die off in the processing then how much good can be done? Last year when I sent off tissue samples, I realized that many of the labs who claimed to have a high count of MSC’s, actually showed very few live cells. Why is this when the research clearly shows that these cells exist?
Other labs using the common practice of a cryo-mill can cause cell lysate and then when enzymes, are compromising the healing characteristics of the cells and is one of the reasons clinical results may not be where you would like them to be.
Using enzymes, while you’re freeing the cells from rigid structures like cord tissue and membranes, you’re also potentially damaging some of the more complex proteins, your scaffolding, which has been shown to by itself have some clinical effects, is being compromised. There are just so many compromises.” — Elliot Spencer, Phd.
Using a cryomill for example which is a commonly and well known method for processing these birth waste tissues where you’re essentially creating cell lysate. If the tissue is manipulated with the various methods used in the industry, then sensitive proteins, cells and enzymes could possibly be damaged when trying to free the cells. The processing separate compartments may be compromising the integrity of the cells and proteins.
These are still great products and this is not meant to slight any one in any way, but when my aim is to help a 96-year old lady regrow cartilage in her achy knees, I can’t risk having a compromised product. Or when I’ve got a patient with ALS who is heading towards hospice and looking for any slight possibility of getting help and I’ve got the last shot in the game, I want to stack as many odds in my favor as possible and can’t risk anything going wrong. This is why I’ve spent thousands of dollars testing products on my own, and thousands of hours finding the best labs to work with. I owe it to you and our patients. I want to have 100% integrity—when I tell a person that I will do everything I can to help them, I feel like this research is keeps me aligned with my promise.
Colonizing Over Counting: the next level in looking at the quality cell products.
Flow Cytometry:Cell counts are exciting because 5 or 40 or 80 million cells sounds like such a big number that it must guarantee that something good will happen, right? It turns out that biology is not that simple because first of all, cell counts can be easily manipulated based on the type of cytometer being used and the types of tissue structures that can be mistaken for cells can also skew your results for the “better.” Also the interpretation of what those numbers mean can also be taken out of context – I’ve included an example of the results that Another Cell Bank recently released, and how they doctored up the data without approval from the Flow Cytometry Director, James Marven or from the University of Utah.
Did this other Cell Bank use the gold standard in counting with the Flow Cytometer? Absolutely, but the only problem occurred when they filled in the gaps of the data without permission from the third party. This is what most of your cell reports are doing today is creating a arm wrestling competition to see who’s “count” is highest…
The problem with cell count is that when you’ve taken cells out of their native environment and then process, freeze and thaw them, they may appear to be alive under a microscope or with flow cytometry, but can still rapidly undergo programed apoptosis before transplantation. While it’s still an important marker, an even more important marker is called the CFU assay, or Colonizing Forming Units. This test determines if the cells can actually form colonies to create new tissues, once they are placed in their new environment. Similar to Elon Musk succeeding at landing on Mars but then realizing that it’s inhospitable to humans. Or it’s like telling someone that we think they are diabetic because their fasting glucose was too high but then not running an Hemoglobin A1c to verify.
BIGGER PURPOSE, WHY WE DO WHAT WE DO
We’ve got a perfect environment right now to do this the right way, and if we work strategically together we can create an amazing future in healthcare with cell therapy.
Our goal is to help 1 million people become free of pain and chronic disease with cell therapy by 2025 and we can’t do that if our clinical results are compromised in any way. We are pioneers in a new era of medicine that needs the highest level of integrity from the onset so that this practice will be thriving 100 years from now. I don’t see this as the next trend that Dr. Oz will soon promote and then forget about, I see us finally going back to nature and using what’s already available. We are building the foundation for cell therapy as the new medicine for future generations and it’s our job to create the best possible practices with this invaluable birth tissue.
I’m committing to moving cell therapy beyond the regenerative medicine world and into the new genre of lifestyle and holistic medicine for the next 25 years. I’m deeply honored to have each one of you embarking on this journey with me!
Thank you for being a part of our mission.
My very best,