Stem Cell Therapy and Regenerative Medicine
Stem Cell Therapy and other biological medicines are on the cusp of changing how we treat many diseases and serious illness. In reviewing the medical literature and many types of stem cell therapy available, we've selected Predictive Biotech's line of cell and tissue-based products. Our hope is to be able to help our patients make major strides in improving their health through this new and evolving field of regenerative medicine.
There's a great deal of information (and hype) online about the potential of stem cells and cell-based therapies. Here, we hope to educate you about the current state of regenerative medicine and let you know why we chose Predictive Biotech.
Regenerative medicine is the process of creating living, functional tissues to repair or replace tissue or organ function lost due to age, disease, damage, or congenital defects. While this covers alot of ground, much of the interest and research is in stem cells. Stem cells are master cells in the body that can differentiate into many different types of cell types to repair and replace worn out cells. As we get older, we have fewer stem cells in our body and our stem cells get older too, so their ability to multiply and repair diminish over time.
Early interest in stem cells involved embryonic stem cells, along with the ethical problems that arose. Since then, researchers have been able to take skin and blood cells and induce them into becoming stem cells (called induced Pluripotent Stem cells, iPS for short). The problem with both embryonic stem cells and iPS is that, by their nature, there is a very high risk of a tumor forming called a teratoma, which could require surgery and chemotherapy, though continued research is ongoing.
For decades, researchers have been looking for other potential sources of stem cells. Today,
the most common form of elective stem cell therapy involves harvesting your own stem cells from bone marrow or adipose tissue (i.e. your fat). Bone marrow is aspirated by drilling into your bone, then processed, and put back into your body by local injection or intravenously. For adipose derived stem cells, fat is removed from your body and processed. In both cases, you are receiving your own, aged stem cells.
Bone marrow is a relatively rich source of stem cells, but it actually has two different types of stem cells. These stem cells are called Hematopoietic Stem Cells and Mesenchymal Stem Cells, but we'll just call them HSCs and MSCs for short. HSCs are stem cells that give rise to several different types of blood-type cells and has been FDA approved for use with certain types of cancer, as well as certain types of blood and immune disorders.
Mesenchymal Stem Cells (MSCs) are of a much broader interest because they can turn into, well, just about everything else in your body besides blood cells or the the specialized cells of certain organs and organ systems. When you think MSCs, think, muscle, bone, cartilage, tendons, ligaments and all the other connective tissue that holds you and your organs together. Because they turn into so many different types of cells, there's great interest in their use for many different diseases and health problems.
The FDA and Stem Cells
In addition to these stem cell procedures, there are a number of enterprising physicians and Phd's who have come up with potentially groundbreaking approaches to stem cells. They've done innovative things like grow the concentration of stem cells in the lab, inject viruses into stem cells to treat cancer, or generally manipulate the original stem cells in ways that make it far different from the original tissue.
While some of these approaches may hold great potential, the FDA announced in December of 2017 that they will be shutting these types of stem cell clinics down. The FDA considers the manipulation or undue processing of biological tissue akin to creating a new drug. While one innovation may cure cancer, another one could cause it or create other health consequences without further study. It's a reasonable approach from a public safety perspective, however the normal FDA drug approval process takes 12 years and about $2.6 billion, so it may be some time before any of these potential innovations are available in the US. Some desperate patients are traveling south of the border and spending as much as $30,000 for a single round of these treatments.
The FDA makes only one exception for tissue transplants such as stem cells - with two requirements. The tissue must be "minimally manipulated" and promoted by the manufacturer as only for "homologous use". These are both very technical terms best explained by $500/hr laywers, but simply put, "minimally manipulated" means you can't substantially modify, concentrate or process the original tissue being transplanted. In terms of "homologous use", the tissues should only be meant to repair, reconstruction, replace, or supplement existing cells. The rules also specifically preclude the manufacturer from claiming or promoting any kind of systemic effect, such as having a positive effect on many different parts of the body - even if it potentially does.
Umbilical Cord Tissue - The Big Breakthrough in Mesenchymal Stem Cells (MScs)
Researchers have found that umbilical cord tissue is a very, very rich source of stem cells. These are stem cells that are harvested from the umbilical cord after a live birth with no harm at all to the fetus. Many parents are now using cord banks to store umbilical cord blood for potential future use. In addition to the cord blood, which has many HSCs (blood-type stem cells), umbilical cords contain a gelatinous substance called Wharton's Jelly, first discovered and described by Dr. Thomas Wharton over 400 years ago.
Wharton's Jelly is a very rich source of MSCs, and according to research, has a higher concentration of MSCs than either bone marrow or adipose tissue. Further, getting MSCs from umbilical cord tissue is essentially like receiving 1 day old stem cells. Stem cells from newborns multiply faster, are healthier and live longer than stem cells from a 30, 50, or 70 year old patient. MSCs from umbilical cord tissue is also considered "immune privileged", meaning they aren't recognized as foreign by the immune system so no donor matching is required. The evidence strongly suggests that MSCs from umbilical cords are superior to bone marrow or adipose tissue and don't require a medical procedure to harvest them.
Due to the nature of MSCs and Wharton's Jelly in particular, there's interest and ongoing research and studies underway for treating a wide variety of diseases. As of early 2018, about 600 clinical studies on MSCs for various conditions are either underway or have been completed. For a full list go to ClinicalTrials.Gov. Many of the results are simply amazing, but it will take many years before the FDA approves stem cells for many of these conditions.
But why wait?
Only recently has Wharton's Jelly become commercially available, with just a few companies having developed the methods and procedures to collect, process and store it. After an extensive review of what's available, we've found that Predictive Biotech's line of MSCs and related biological products are the best, and why we have it available at our Clinic.
Predictive's main MSC product is called CoreCyte. Not only do they harvest Wharton's Jelly, but they harvest CoreCyte specifically from the portion of Wharton's Jelly that's highly concentrated in MSCs. The resulting is a concentration of MSCs that's substantially higher than other Wharton's Jelly's products available.
In addition to CoreCyte, Predictive Biotech also has 3 additional tissue products derived from umbilical cord tissue (PolyCyte), amniotic fluid (AmnioCyte) and placental tissue (AmnioCyte Plus). Each of these biological tissues has specific properties that are useful for various conditions and we'll expand on those in the future. All of Predictive Biotech's products are available for use in the US right now because they meet the FDA requirements of being "minimally manipulated" and sold only for "homologous use".
Predictive Biotech has also has filled their company with seasoned researchers and health-care executives, and is owned by a publicly traded company, Predictive Technology Group. These are all good signs if you are looking for the best technology available for stem cells and other biological drugs. In 2019, Senator Orrin Hatch joined their Board of Directors.
We hope you have learned a bit about stem cells. If you have further questions, don't hesitate to email us or call the office to talk with Dr. Jen Wicher ND, to help you decide if stem cells and other biological medicines are right for you.
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