Stem cells become a buzz word in the late 20th Century and we try to give a comprehensive overview of what they are, their actual use and the complex regulation in different countries. In the US, but also in Europe the regulatory agencies have approved only a very few drugs on the basis of stem cells but non of the clinics nor the use of stem cells as a medical procedure.
On the other hand, this is however legalized in various countries outside the Western Countries not dominated by FDA and the industry and its safety regulation. Hundreds of clinics all over the world, including the US and Europe are doing stem cell therapies as a medical procedure with anecdotal success and very good safety records. Here will try to summarize the actual situation by diving into the subject as follow:
1. Regulation - General overview
2. Stem cells the repair team of our cellular structure
3. What are stem cells
4. Stem cells, Potency and from where they are harvested
5. Autologous & Allogeneic stem cells in medical procedures
6. Stem cells in Veterinary Medicine
7. Dr. A. Caplan - Mesenchymal Stem Cells a scientific update
As we are embedded in Western regulations, not allowing the promotion of unapproved medicine or medical treatment, we need to draw your attention to our disclaimer, that we are not promoting any unauthorized medicine nor treatments and that any information given in our website had not been reviewed nor approved by FDA / EMA and therefore reflects opinions for educational and informative purpose only.
On the other hand, this is however legalized in various countries outside the Western Countries not dominated by FDA and the industry and its safety regulation. Hundreds of clinics all over the world, including the US and Europe are doing stem cell therapies as a medical procedure with anecdotal success and very good safety records. Here will try to summarize the actual situation by diving into the subject as follow:
1. Regulation - General overview
2. Stem cells the repair team of our cellular structure
3. What are stem cells
4. Stem cells, Potency and from where they are harvested
5. Autologous & Allogeneic stem cells in medical procedures
6. Stem cells in Veterinary Medicine
7. Dr. A. Caplan - Mesenchymal Stem Cells a scientific update
As we are embedded in Western regulations, not allowing the promotion of unapproved medicine or medical treatment, we need to draw your attention to our disclaimer, that we are not promoting any unauthorized medicine nor treatments and that any information given in our website had not been reviewed nor approved by FDA / EMA and therefore reflects opinions for educational and informative purpose only.
1. Regulations of Stem Cells
When it comes to regulation of stem cells and its therapeutic use there is a wide range of interpretation what is legally possible and what is not allowed as it depends on a country's religious view, political concept and health regulation, and not on early science driven advancement to improve quality of life of individuals.
FDA and EMA stipulated that any stem cell related therapy need their approval as stem cells regardless their source are considered to be drugs......even though, thousands of stem cell therapies are performed as a medical procedure also in the USA and worldwide, which the FDA tries to stop since years via guidelines and legal actions. BUT, in December 2022 the FDA lost its case against Cell Surgical Network, California, performing stem cell therapy from adipose tissues since more that 10 years quite successful, giving those clinics, performing stem cell therapies in the USA, a break from various FDA legal and new guideline attacks.
It appears that the USA is trying to dominate the global health care environment with its stringent philosophy and regulations that stem cells are drugs and need therefore to follow the clinical trial pathway, before approved and administered at human beings. This regulations are based on the early 20th Century need to regulate the quality of industrial produced drugs. Today these regulations are by health care advocates and regulatory agents alike seen very controversial, resulting that some countries adjusted their regulations either to approve novel therapies and drugs easier, while others in the name of safety concerns made the barriers even higher, by calling it non-approved medical therapies.
The difference in these country specific policies may be potentially found in the belief that stem cell therapy is either a novel, but already safe treatment possibility whereas others stress safety points for new drugs, regulated via evidence based medicine and potentially - nobody talks about this openly - the financial interest of the business model of the health care industry. In an article of the TIME magazine, some time ago, on the first page there was a provocative statement reading more or less:
"Is curing a sustainable business model of the pharmaceutical Industry?"
You guessed certainly the answer! .....
NO, because the customer base would disappear!
You guessed certainly the answer! .....
NO, because the customer base would disappear!
So, in summary, Stem Cell Therapies are considered by most regulatory organisations, as potentially curing, but a non approved drug treatment........well, well,............But, in spite of this general statement, thousands of stem cell treatments, financed by patients, with own stem cells from fat and bone marrow as well as allogeneic stem cells from umbilical cord tissues, even expanded, are performed globally every year, mostly successful and with non or neglectable side effects.
The general science based understanding, expressed in many international journals and publications of clinics, is, that stem cell therapies are safe and if performed as a medical procedure it is allowed legally, at least in various countries, and somewhat tolerated by those who want to regulated it as a drug.
In case you intend to engage in such a therapy, ask your provider to provide a certified statements permitting stem cell therapies of his country or contact us, we are able to organizing a qualified and legalized stem cell therapy clinic for you.
I have a personalized experience as a health maintenance and anti aging concept, by being injected about 4 years ago with about 100 Million expanded Mesenchymal stem cells from an umbilical cord at my Indian Biotech partner. which certainly helped me to stay continuously healthy even during the difficult Covid 19 situation where I, even not convinced, was injected with three Pfizer jabs due to my travelling activity. Anyhow, neither the epidemic situation nor the so-called vaccination had any negative effect on my health so far, quite in the contrary, I enjoy travelling, be very healthy (2023) and physically active at my wellness farm project at 77 years young!
Details and updates on international Regulations can be read at the site News.
The general science based understanding, expressed in many international journals and publications of clinics, is, that stem cell therapies are safe and if performed as a medical procedure it is allowed legally, at least in various countries, and somewhat tolerated by those who want to regulated it as a drug.
In case you intend to engage in such a therapy, ask your provider to provide a certified statements permitting stem cell therapies of his country or contact us, we are able to organizing a qualified and legalized stem cell therapy clinic for you.
I have a personalized experience as a health maintenance and anti aging concept, by being injected about 4 years ago with about 100 Million expanded Mesenchymal stem cells from an umbilical cord at my Indian Biotech partner. which certainly helped me to stay continuously healthy even during the difficult Covid 19 situation where I, even not convinced, was injected with three Pfizer jabs due to my travelling activity. Anyhow, neither the epidemic situation nor the so-called vaccination had any negative effect on my health so far, quite in the contrary, I enjoy travelling, be very healthy (2023) and physically active at my wellness farm project at 77 years young!
Details and updates on international Regulations can be read at the site News.
2. STEM CELLS
THE REPAIR TEAM OF OUR CELLULAR STRUCTURE
Any living organisms with a cellular structure have a build in repair mechanism. Those cells involved in the repair of damaged tissues and organs are stem cells, and attracted to sites of injured tissues by “alarm signals.” In this way, these cells proliferate, migrate, and accumulate in those damaged places. Pain is therefore considered the signal of the body, saying something does not function well.
As we age, the production of stem cells in a human body is reduced by using those cells for the repair and maintenance of our tissues, i.e. we, over time, have simply fewer stem cells available in our body to fight the natural wear and tear process of our cellular structure. This is considered by scientists as "Stem Cell Exhaustion"
The concept of introducing new stem cells to our bodies circulation has shown in anecdotal studies the improved capability to support health and health maintenance with the repopulated stem cell pool. Some of the well-known sources of MSCs are bone marrow, fat, and umbilical cord tissue.
There are various technology of extracting autologous stem cells from a body in an area of high cellular volume, like fat, or Bone Marrow, then purifying and in some cases concentrating and cryopreserving those cells, before using them at the same body therapeutically. Many clinics offering this, if minimally manipulated, also in the USA, like the Cell Surgical Network in California.
Allogeneic stem cells are harvested also from various tissues of the body mainly from Umbilical Cord tissue and re-injecting them into the damaged area, as a medical procedure, helping the cellular structure to regenerate naturally. The video below talking about Mesenchymal stem cells and its activities in general. As mentioned before the FDA categorized stem cell as drugs and according to them treatment is not permitted in the USA, but some countries have already legalized such procedures. Panama and Costa Rica are one of them.
Allogeneic stem cells are harvested also from various tissues of the body mainly from Umbilical Cord tissue and re-injecting them into the damaged area, as a medical procedure, helping the cellular structure to regenerate naturally. The video below talking about Mesenchymal stem cells and its activities in general. As mentioned before the FDA categorized stem cell as drugs and according to them treatment is not permitted in the USA, but some countries have already legalized such procedures. Panama and Costa Rica are one of them.
Stem cells performing this "regeneration process" in our body are called Hematopoietic stem cell and Mesenchymal stem cells. Hematopoietic stem cells (HSC) are blood related cells and used legally in various types of blood cancer. Mesenchymal stem cells (MSC) are related to repair tissues and organs of a body and are under investigation via clinical trials.
In the Video Series “Live Longer, Feel Better” Dr. Riordan and Mel Gibson discuss stem cell therapy in Panama. One more clear documentation that stem cell treatment as a medical procedure is benefiting patients without negative side effects.
Vídeo credits by: RMI Clinic / Stem Cell Institute
MSCs have the potential to treat various degenerative disorders including neurological, optic, orthopedic, liver, kidney among others. We believe that maintenance of our body is a very important instrument to stay healthy while aging. Our holistic “maintenance concept” includes various stem cell treatments, and additional Complementary and Alternative Medicine, which can support longevity and health for many years to come.
In order to understand better the potential of stem cell therapy we have sumarized below available information about stem cells. So, what are stem cells?
3. What are Stem Cells
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A stem cell is the main building block of the human body.
When they divide, they can make either any one of the 220 different cell types in the human body or they can reproduce themselves, i.e. having the capability of self-renewing. Stem Cells, during the lifetime of a human being, are acting like “maintenance crews” helping a human body to maintain and restore its cellular structure and function as its neural network is directing stem cells to areas of disease, injury or inflammation. Stem cells are the most important art of the Human biological system of about 100 Trillion cells, embedded in an electromagnetic energy field, communicating with its specific neural network, able to exchange and analyze information and with this, initiating impulses triggering biological, electrical and chemical-related reaction at its cellular basis |
What is a stem cell?
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This natural regenerative capability can be influenced in various ways involving stem cells. Today we can divide stem cells into basically four main kinds of cells:
The first two (Embryonic and Adult Stem Cells) are part of the natural development of beings, whereas the group 3 and 4 (iPSC and Gene manipulated cells) are men made, artificially developed and highly manipulated cells. The difference between CRISPR and CAR-T cell therapy is that CRISPR is a gene editing technology, while CAR-T cells are cells that have been created using gene editing technology.
- Embryonic Stem Cells
- Adult Stem Cells
- Induced Pluripotent Stem Cells (iPSC)
- Gene manipulated cells (CRISPR - CART)
The first two (Embryonic and Adult Stem Cells) are part of the natural development of beings, whereas the group 3 and 4 (iPSC and Gene manipulated cells) are men made, artificially developed and highly manipulated cells. The difference between CRISPR and CAR-T cell therapy is that CRISPR is a gene editing technology, while CAR-T cells are cells that have been created using gene editing technology.
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While Embryonic Stem Cells are responsible to build the human body from the fertilized egg, until a baby is born, Adult Stem Cells develop from embryonic stem cells, than become fetal stem cells and with the birth of the baby, its cells mature into adult stem cells. Those adult stem cells are the reserve supply of cells that can multiply when needed to repair, regenerate damaged organs and tissues. Adult stem cells are readily available for personalized autologous medical treatments as they can be harvested easily and returned without heavy manipulation back to the same individual to help a body to restore itself. When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell. |
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Stem Cells & Tissue Regeneration - A Scientific Review
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Stem cells are distinguished from other cell types by two important characteristics. First, they are unspecialized cells capable of renewing themselves through cell division, sometimes after long periods of inactivity. Second, under certain physiologic or experimental conditions, they can be induced to become tissue- or organ-specific cells with special functions. In some organs, such as the gut and bone marrow, stem cells regularly divide to repair and replace worn out or damaged tissues. In other organs, however, such as the pancreas and the heart, stem cells only divide under special conditions.
The video by Dr. Jill Helms, Associate Professor of Surgery at the Stanford School of Medicine, in 2009, discusses, easily to understand, the developments in stem cell research and the future of regenerative medicine. |
Researchers already in 2006 made another breakthrough in stem cell science by identifying conditions that would allow some specialized adult cells e.g. skin cells to be “reprogrammed” genetically to assume a stem cell-like state. This new type of adult-derived stem cell, called “induced pluripotent stem cells (iPSCs)”. Japan in 2022 is leading the research in the field of iPSCs.
iPSCs are adult cells that have been genetically reprogrammed to become an embryonic stem cell-like cellular structure by being forced to express genes and factors important for maintaining the defining properties of embryonic stem cells. Although these cells meet the defining criteria for pluripotent stem cells, it is not (yet) known if iPSCs and embryonic stem cells differ in clinically significant ways.
Mouse iPSCs were first reported in 2006, and human iPSCs were first reported in late 2007. Mouse iPSCs demonstrate important characteristics of pluripotent stem cells, including expressing stem cell markers, forming tumors containing cells from all three germ layers, and being able to contribute to many different tissues when injected into mouse embryos at a very early stage in development.
Those stem cells are experimental and genetically modified and became a new field of stem cell research, and it remains to be seen whether they do not develop unwanted side effects due to their strongly manipulated and modified structure. Genetically manipulated cells so-called CART-T Cells are going even one step further and will have to follow the clinical trial route before approved for human treatments. Even though investment into stem cell research exploded since the early times in 2006, no approval of a mainstream stem cell product for one of the main chronic diseases had been given my regulatory authorities, but a few for non mainstream illnesses.
iPSCs are adult cells that have been genetically reprogrammed to become an embryonic stem cell-like cellular structure by being forced to express genes and factors important for maintaining the defining properties of embryonic stem cells. Although these cells meet the defining criteria for pluripotent stem cells, it is not (yet) known if iPSCs and embryonic stem cells differ in clinically significant ways.
Mouse iPSCs were first reported in 2006, and human iPSCs were first reported in late 2007. Mouse iPSCs demonstrate important characteristics of pluripotent stem cells, including expressing stem cell markers, forming tumors containing cells from all three germ layers, and being able to contribute to many different tissues when injected into mouse embryos at a very early stage in development.
Those stem cells are experimental and genetically modified and became a new field of stem cell research, and it remains to be seen whether they do not develop unwanted side effects due to their strongly manipulated and modified structure. Genetically manipulated cells so-called CART-T Cells are going even one step further and will have to follow the clinical trial route before approved for human treatments. Even though investment into stem cell research exploded since the early times in 2006, no approval of a mainstream stem cell product for one of the main chronic diseases had been given my regulatory authorities, but a few for non mainstream illnesses.
4. Stem cells and Potency
The main difference between embryonic stem cells and adult stem cells is the type of potency. Potency of the stem cell specifies the differentiation potential i.e., the potential to differentiate (develop) into other cell types. The following summarizes the “potency of stem cells”:
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Totipotent
Totipotent are stem cells that can differentiate into embryonic and extra embryonic cell types. Such cells can construct a complete, viable organism. These cells are produced from the fusion of an egg and sperm cell. Totipotent stem cells give rise to somatic stem/progenitor cells and primitive germline stem cells. |
Pluripotent
Pluripotent are stem cells that are the descendants of totipotent cells and can differentiate into nearly all cells, i.e. cells derived from any of the three germ layers. They are characterized by self-renewal and a differentiation potential for all cell types of the adult organism. |
Multipotent
Multipotent are stem cells that can differentiate into a number of cells, but only those of a closely related family of cells. For example, the bone marrow contains multipotent stem cells that give rise to all the cells of the blood but not to other types of cells. Adult Haematopoietic Stem Cells are multipotent. |
Oligopotent
Oligopotent are stem cells that can diffentiate into only a few cell types, such as lymphoid or myeloid stem cells. In general, they able to form two or more mature cell types within a tissue. The corneal epithelium is a squamous epithelium that is constantly renewing and is Oligopotent. |
Unipotent
Unipotent are cells that can produce only one cell type, their own, but have the property of self-renewal, which distinguishes them from non-stem cells. Such Unipotent cells include muscle stem cells. Most epithelial tissues self-renew throughout adult life due to the presence of unipotent progenitor cells. |
5. Autologous & Allogeneic stem cells in medical procedures
As mentioned before, Adult Stem Cells develop from embryonic stem cells, then become fetal stem cells and with the birth mature into adult stem cells. Adult stem cells can be extracted from many areas of the body, including the bone marrow, fat, and peripheral blood, and umbilical cord tissues. Once the cells have been harvested, they are either processed at the clinic, where they are purified and evaluated for quality before being reintroduced back into the patient, or sent to a lab for expansion and cryopreservation for later use of the patient. Since this type of stem cells come from the same patient there is no possibility of rejection, but as they have the same age as the patient, its effectivity is according to the age of the patient.
This treatment is considered to be a medical procedure, where a patient and a medical professional agree in a written consent to a patient funded treatment, based on new scientific insights, usually approved by the Institutional Reviewing Board (IRB) or an Ethical Committee, especially in cases where standard medicine has shown no improvement of the condition of the patient.
Adult Stem Cells also called Somatic Stem Cells exist naturally in the body. They are important for growth, healing, and replacing cells that are lost through daily wear and tear and carry all information naturally to support the cellular structure of a body.
Adult stem cells are the reserve supply of cells that can multiply when needed to repair, regenerate damaged organs and tissues. We can visualize this repair and regeneration capability of stem cells by using a “Pharmacy as a model”.
In our Pharmacy model, on day one in the morning, when the pharmacy is fully stocked with medicaments it will during the day dispense those medicaments stored to patients in need. In our model “day one” equals the birth of the baby fully loaded with all kinds of cells, stem cells and growth factors for future repair needs of the body. While the baby is growing, the body, or in our pharmacy model, the clients, are using up the stock of the pharmacy. In a real pharmacy, the supplier of medicaments always replaces what had been taken by the clients during the night, so that next day the pharmacy is fully loaded with medicaments again. This capability to replenish the depot is limited in the human body and over time the cellular structure becomes weak, although stem cells have the capability to renew themselves, i.e. make copies, but the quantity and quality is just reduced over time. This is called Stem cell exhaustion. By injecting new stem cells the body structure gets a boost and improved healing and repair can be seen.
Scientist belief, that illness and aging is a result of the incapacity of a human body to regenerate, i.e. produce stem cells, as those cells used for regeneration derive from the “depot in our body” the bone marrow, are either exhausted or damaged.
This treatment is considered to be a medical procedure, where a patient and a medical professional agree in a written consent to a patient funded treatment, based on new scientific insights, usually approved by the Institutional Reviewing Board (IRB) or an Ethical Committee, especially in cases where standard medicine has shown no improvement of the condition of the patient.
Adult Stem Cells also called Somatic Stem Cells exist naturally in the body. They are important for growth, healing, and replacing cells that are lost through daily wear and tear and carry all information naturally to support the cellular structure of a body.
Adult stem cells are the reserve supply of cells that can multiply when needed to repair, regenerate damaged organs and tissues. We can visualize this repair and regeneration capability of stem cells by using a “Pharmacy as a model”.
In our Pharmacy model, on day one in the morning, when the pharmacy is fully stocked with medicaments it will during the day dispense those medicaments stored to patients in need. In our model “day one” equals the birth of the baby fully loaded with all kinds of cells, stem cells and growth factors for future repair needs of the body. While the baby is growing, the body, or in our pharmacy model, the clients, are using up the stock of the pharmacy. In a real pharmacy, the supplier of medicaments always replaces what had been taken by the clients during the night, so that next day the pharmacy is fully loaded with medicaments again. This capability to replenish the depot is limited in the human body and over time the cellular structure becomes weak, although stem cells have the capability to renew themselves, i.e. make copies, but the quantity and quality is just reduced over time. This is called Stem cell exhaustion. By injecting new stem cells the body structure gets a boost and improved healing and repair can be seen.
Scientist belief, that illness and aging is a result of the incapacity of a human body to regenerate, i.e. produce stem cells, as those cells used for regeneration derive from the “depot in our body” the bone marrow, are either exhausted or damaged.
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On average each of us replaces, i.e. regenerates about 1.7 to 2.5 Million Cells per second, from the about 80 to 100 plus trillion cells any human has. We are not really aware of the cellular activities in our body, but it is happening all the time. We also need to understand that the rate of red blood cell production slows as we grow older. The reason for this is each cell has chromosomes, which contain our DNA. At the end of our chromosomes, we have “caps” called telomeres
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As our cells divide, these telomeres begin to shrink. Each time the cell divides the telomere gets shorter, the chromosomes are less protected and finally, the chromosomes are exposed to damage, and cell division stops. So, cell division slows as we age.
Furthermore, when younger, we are growing and so our body not only has to replace dying cells but make new cells for growth. When humans reach adulthood, our body ceases growth. |
As a simple example, when we cut our finger accidentally with paper, it hurts, the cells around the injury, the cut, signals to the cellular system we have a problem, and with this signal we are initiating the message to the various cell types “fix it”!
Millions of cells are mobilized to close the wound and heal the cut….a process which is happing automatically! With age, we have fewer stem cells and growth factors and the capability to heal our body slows down eventually.
Research has, however, shown that by harvesting stem cells from e.g. bone marrow or adipose tissue (fat) and especially umbilical cord tissue / Wharton Jelly, and injecting it to a body has the capacity to “increase the reserve” in our body and helps the natural capability to increase healing of various illnesses due to the so-called “homing capability” of stem cells, meaning they are automatically, after re-injected into the body, travel to those places (wounds) where needed.
Millions of cells are mobilized to close the wound and heal the cut….a process which is happing automatically! With age, we have fewer stem cells and growth factors and the capability to heal our body slows down eventually.
Research has, however, shown that by harvesting stem cells from e.g. bone marrow or adipose tissue (fat) and especially umbilical cord tissue / Wharton Jelly, and injecting it to a body has the capacity to “increase the reserve” in our body and helps the natural capability to increase healing of various illnesses due to the so-called “homing capability” of stem cells, meaning they are automatically, after re-injected into the body, travel to those places (wounds) where needed.
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Adult stem cells have been identified in many organs and tissues, including the brain. Bone marrow, peripheral blood, blood vessels, fat tissues, skeletal muscle, skin, teeth, nose, heart, gut, liver, ovarian epithelium, and testis to name a few of the 220 different cells in the human body. They are thought to reside in a specific area of each tissue, called a “stem cell niche”
Regenerative medicine is using stem cells mainly from umbilical cord blood, cord tissues (Wharton Jelly), bone marrow, peripheral blood and more recently from adipose tissues a fatty tissue from where stem cells can be easily harvested. |
The primary function of adult (somatic) stem cells is to maintain tissue homeostasis by replenishing senescent (growing old, dying cells) or damaged cells. Homeostasis can be defined as a property of an organism that helps it maintain its parameters within a normal range of values. It is key to life, and failures in homeostasis can lead to diseases like hypertension and diabetes.
The advantage of autologous stem cells is, that without expanding them, a physician can harvest a small quantity which already has a therapeutic value. New technology to extract stem cells has increased the number of harvested stem cells considerably. |
Regeneration and antiaging is probably the most important possible medical application of stem cells in the 21st-century medical advancements. Currently, organs must be donated, harvested and transplanted, but the demand for organs far exceeds supply.
The allogeneic stem cell treatment method follows mainly the pharmaceutical business model, with clinical trials in respect of safety and efficacy, which will take many years, and millions of dollars to develop a “nearly side-effect free” medical product. Those medical products, considered as “stem cells in a bottle” for use like a pharmaceutical drug will not take only years to develop due to the high potential of unwanted side effects like teratomas (cancerogenic) developments, but also will become extremely expensive to those having to pay for the treatment.
In our science driven health care model, we are using autologous as well as allogeneic stem cells as a medical procedure which has shown interesting healing effects in all kind of illnesses.
The allogeneic stem cell treatment method follows mainly the pharmaceutical business model, with clinical trials in respect of safety and efficacy, which will take many years, and millions of dollars to develop a “nearly side-effect free” medical product. Those medical products, considered as “stem cells in a bottle” for use like a pharmaceutical drug will not take only years to develop due to the high potential of unwanted side effects like teratomas (cancerogenic) developments, but also will become extremely expensive to those having to pay for the treatment.
In our science driven health care model, we are using autologous as well as allogeneic stem cells as a medical procedure which has shown interesting healing effects in all kind of illnesses.
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The main source for autologous stem cells is bone marrow and more recently adipose tissue (fat). The advantage of autologous Stem cells (own) is that there is no need of immune-depressants and the risk of infection is next to non-existent as you use your own, cell structure.
Furthermore, they can be harvested quickly and easily, purified and redeployed to the same body at the same day surgical / medical procedure which takes between 3 and 4 hours at a qualified clinic. Details about adipose derived stem cell process you can find in the video next to this text. Aristoloft is partner of Cell Surgical Network, California since 2016. |
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Regenexx is an other very successful clinic in the US concentrating on treatment Orthopedic related problems by using stem cells from the patients bone marrow.
The video beside shows how the treatments is performed with an even patented specific know how to improve the patient's condition. Furthermore, the costs of this kind of medical treatment are much less than those treatments with patented and approved drugs, although the medical effect for a patient appears to be the same or similar with much less side effects. |
In 2022, about 1000 clinics in the US alone are, in one or the other way, performing mesenchymal stem cell treatment, as a medical procedure. They are all somehow under regulatory and legal "attack" by the FDA, claiming that they are performing unauthorized stem cell treatments, How long they can perform such medical procedure is difficult to say, but the trial to stop stem cell therapy as a medical procedure as an alternative to allopathic FDA approved medicine to improve health, is intensifying since about 2015.
Fortunately the FDA in 2022, lost the case against Cell Surgical Network, allowing the Network to continue treating patients with own, autologous, stem cells as a medical procedure, as Stem cells harvested from a body are not considered to be drugs by the court.
This recent legal result, clearly also shows the difficulty of understanding new science and its application, especially advanced early new scientific knowledge at all levels of society, however obviously more at regulatory agencies who intend potentially to protecting the clinical pathway for the development of profitable pharmaceuticals regardless the unmet medical need of patients not being cured by available approved medical drugs. Approved drugs mainly treat symptoms without acting on the root cause, therefore, the need to use it continuously in even higher doses over time is a part of the present approval process.
Human stem cells are natural repair cells of a human body and do not need to be manipulated nor taught to initiate repair or performing health maintenance in a body, because this is their natural activity. With age the number of stem cells and its quality in a body are reduced, resulting that health conditions deteriorate, but with a stem cell boost, i.e. adding autologous or allogeneic mesenchymal stem cells, health conditions can improved just due to the additional quantity of stem cells.
The medical procedure has established this concept quite successful, while FDA is arguing in the name of safety of patients, this concept is unauthorized and can only be implemented via clinical trials. This is certainly correct when cells are highly manipulated like in the intensely researched and industry sponsored gene technology, but to apply this regulation to human natural cells and its unmanipulated use is questionable. The FDA argument, that extraction, separation and purifying stem cells at the bedside procedure is changing the nature of stem cells. This had been proven to be not correct with many publications showing that stem cells from fat and bone marrow extracted and used in humans did not show any serious side effects, contrary to many approved pharmaceuticals.
Again, fortunately the FDA in 2022, lost the case against Cell Surgical Network, allowing the Network to at least continue treating patients with own, autologous, stem cells as a medical procedure!
Clinics using expanded mesenchymal stem cells to improve health conditions of patients migrated to countries outside the US in recent years. Those countries are Costa Rica, The Bahamas, Panama, or Mexico to name a few, where stem cell treatment is either legalized or tolerated as a medical procedure.
In countries with a Muslim majority, bioethics is highly dependent on and typically inseparable from religious jurisprudence. Legislation and bioethics principles in many Islamic countries are based on four sources of Islamic law collectively known as Shari’ah: the Holy Quran, Sunnah, Ijma’ (Consensus), and Qiyas (Analogy).
It is not so well known but worthwhile to notice that during the Islamic World League meeting held in Makkah al-Mukarramah, Saudi Arabia, already in 2003, the Islamic Fiqh Council has agreed, that it is permitted to obtain, grow, and use stem cells for therapeutic or permissible scientific research, if the source of the specimen is legitimate. Turkey (Türkiye) and Jordan are leading the way to qualified stem cell therapies as a medical procedure.
Fortunately the FDA in 2022, lost the case against Cell Surgical Network, allowing the Network to continue treating patients with own, autologous, stem cells as a medical procedure, as Stem cells harvested from a body are not considered to be drugs by the court.
This recent legal result, clearly also shows the difficulty of understanding new science and its application, especially advanced early new scientific knowledge at all levels of society, however obviously more at regulatory agencies who intend potentially to protecting the clinical pathway for the development of profitable pharmaceuticals regardless the unmet medical need of patients not being cured by available approved medical drugs. Approved drugs mainly treat symptoms without acting on the root cause, therefore, the need to use it continuously in even higher doses over time is a part of the present approval process.
Human stem cells are natural repair cells of a human body and do not need to be manipulated nor taught to initiate repair or performing health maintenance in a body, because this is their natural activity. With age the number of stem cells and its quality in a body are reduced, resulting that health conditions deteriorate, but with a stem cell boost, i.e. adding autologous or allogeneic mesenchymal stem cells, health conditions can improved just due to the additional quantity of stem cells.
The medical procedure has established this concept quite successful, while FDA is arguing in the name of safety of patients, this concept is unauthorized and can only be implemented via clinical trials. This is certainly correct when cells are highly manipulated like in the intensely researched and industry sponsored gene technology, but to apply this regulation to human natural cells and its unmanipulated use is questionable. The FDA argument, that extraction, separation and purifying stem cells at the bedside procedure is changing the nature of stem cells. This had been proven to be not correct with many publications showing that stem cells from fat and bone marrow extracted and used in humans did not show any serious side effects, contrary to many approved pharmaceuticals.
Again, fortunately the FDA in 2022, lost the case against Cell Surgical Network, allowing the Network to at least continue treating patients with own, autologous, stem cells as a medical procedure!
Clinics using expanded mesenchymal stem cells to improve health conditions of patients migrated to countries outside the US in recent years. Those countries are Costa Rica, The Bahamas, Panama, or Mexico to name a few, where stem cell treatment is either legalized or tolerated as a medical procedure.
In countries with a Muslim majority, bioethics is highly dependent on and typically inseparable from religious jurisprudence. Legislation and bioethics principles in many Islamic countries are based on four sources of Islamic law collectively known as Shari’ah: the Holy Quran, Sunnah, Ijma’ (Consensus), and Qiyas (Analogy).
It is not so well known but worthwhile to notice that during the Islamic World League meeting held in Makkah al-Mukarramah, Saudi Arabia, already in 2003, the Islamic Fiqh Council has agreed, that it is permitted to obtain, grow, and use stem cells for therapeutic or permissible scientific research, if the source of the specimen is legitimate. Turkey (Türkiye) and Jordan are leading the way to qualified stem cell therapies as a medical procedure.
There are many scientific reviews on the safety of using stem cells including Mesenchymal stem cells from Umbilical cord tissue / Wharton Jelly minimally manipulated or expanded as transplants. Here is one of the more recent reviews of the safety of using mesenchymal stem cells from adipose tissues. A review of the safety of using mesenchymal stem cells from Bone Marrow showed the same high safety result.
6. Stem Cells and Veterinary Medicine
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Stem cell research has emerged as an area of major interest for its potential therapeutic applications, and not only in human medical therapy, but also in veterinary medicine.
The effective management of diseases of companion and sport animals requires sophisticated new treatments and preventive strategies with stem cells and regenerative medicine. The main technology to harvest stem cells in animals is from adipose tissues, but also bone marrow has shown its potential for treatment. Furthermore, also in livestock species, stem cell therapy could be used to treat several medical conditions that negatively affect meat and milk production or reproductive efficiency. Like in humans the resistance to antibiotic therapies to treat diseases in animals is becoming a concern. |
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Bovine mastitis is an inflammation of the mammary gland of cows caused from trauma or an infection, leading to abnormal and decreased milk production. Apart from antibiotics, dairy farmers have few tools to treat the common and costly udder infection mastitis. Stem cell research is reviewing how to treat such a difficult to treat disease with cellular therapy.
7. Dr. Arnold Caplan - Stem Cell UPDATE
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For those being interested in continued learning and in updating own science knowledge, this information is an important building block of understanding stem cells and its potential therapeutic use.
In the late 1980s, Dr. Arnold Caplan of Case Western Reserve University was the first person ever to isolate MSCs, from bone marrow, and expand them in culture. He is the one who named them “mesenchymal stem cells,” which, he now points out, is the wrong name. In his testimony before the FDA/CBER (Food and Drug Administration / Center for Biologics Evaluation and Research) in September of 2016, Dr. Caplan stated: "In the late 1980s, I gave the term “Mesenchymal Stem Cells” to a cell, which I was able to isolate from bone marrow, put into culture and expand in culture". |
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That term is wrong, and I apologize for calling it a stem cell. It is not a stem cell. The assumption was that this cell was part of the stroma of marrow. This cell is not a part of the connective tissue or stroma of marrow, it is a perivascular cell, and as a perivascular cell it has a function only in cases of inflammation or injury.
In case of injury and inflammation, this cell comes off the blood vessel and does two things: from its front, it secretes a curtain of molecules which stop your overaggressive immune system from surveying the damaged tissue behind it. And from the back of the cell, it secretes a different group of factors which actually allow the tissue behind it to regenerate in a slow and unscarring process. This, therefore, is a cell which is medicinal in its function. And because I have such a delicate ego, I have written an article which asks my colleagues to continue to use the MSC nomenclature, but I’ve renamed this cell a “Medicinal Signaling Cell.” So therefore, when I lecture, I beg the audience to not use the stem cell nomenclature."
“Medicinal Signaling Cell" — this is the term that should replace “Mesenchymal Stem Cell,” as described by the “Father of the Mesenchymal Stem Cell,” the very scientist who first isolated and named the cell.
Independently of this discussion, and the proposed alternative term and the understanding of what are MSCs, the fact is, that MSC are valuable sources for regenerative medicine and science since 2014 it has not changed its term, i.e. referring to “MSC still as Mesenchymal Stem Cells”.
Like to know more about stem cells and its therapeutic use, please contact us.
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Aristoloft
MEDICAL PROCEDURE
A medical procedure with or without the approval of an Ethical Committee in Europe or the Institutional Reviewing Board, in the US, has nothing to do with ” being prepared industrially or manufactured by a method involving an industrial process nor are intended to be placed on the market in the Member States” it is a personalized activity for a singular medical case.
The Declaration of Geneva of the World Medical Association (WMA), emphasizes and binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that “A physician shall act in the patient’s best interest when providing medical care.”
Furthermore, the World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. This declaration in its paragraph 37, stipulates:
The Declaration of Geneva of the World Medical Association (WMA), emphasizes and binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that “A physician shall act in the patient’s best interest when providing medical care.”
Furthermore, the World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. This declaration in its paragraph 37, stipulates:
UNPROVEN INTERVENTION IN CLINICAL PRACTICE
In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering.
This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.
In the US there are about 750 clinics (2018) / 1500 clinics estimated in 2022 providing stem cell treatment in accordance with FDA regulation 1271 15b as a medical procedure while in Europe only a few have utilized the new treatment method, reflecting the treatment potential of stem cells in accordance with the Declaration of Helsinki.
This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.
In the US there are about 750 clinics (2018) / 1500 clinics estimated in 2022 providing stem cell treatment in accordance with FDA regulation 1271 15b as a medical procedure while in Europe only a few have utilized the new treatment method, reflecting the treatment potential of stem cells in accordance with the Declaration of Helsinki.
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Various countries outside the US and EU, having started to regulate adult stem cell treatments as a medical procedure, and are supporting also those patients who cannot be treated easily in their own countries due to unfavorable regulatory interpretation.
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This situation has resulted in medical tourism to satisfy medical needs of patients, considered by FDA and EU regulated countries as an exploitation of the uneducated patients, where hope and profit come before scientific proof.
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This is certainly an unfair and a not justified statement as many clinics, offering this treatment service, have standards, not only matching but sometimes even out path established Western standards and treat certainly already very well educated and informed patients.
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JAPAN REGULATION
Japan has become the most favorable environment for regenerative medicine after changes to its national laws in November of 2013. The Japanese legal approval process for novel therapies was shortened to be world’s fastest, designed specifically for expedited treatment and trials of regenerative medical therapies.
Consequently, the Japanese market for regenerative treatment is now (2018) projected to experience rapid growth and to be worth US$12.7 Billion by 2030, capturing the major development and share in this field.
Consequently, the Japanese market for regenerative treatment is now (2018) projected to experience rapid growth and to be worth US$12.7 Billion by 2030, capturing the major development and share in this field.
GENERAL
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Furthermore, Stem Cell clinics all over the world are using MAINLY so-called ADULT STEM CELLS harvested from a patient’s own bone marrow or adipose tissue.
This is autologous (own) stem cells. Some clinics have developed the expertise to use expanded MESENCHYMAL STEM CELLS from umbilical cord tissues. Those stem cells are allogeneic (3rd party) stem cells and have as they are expanded a higher quantity of stem cells, important for therapeutic use in the field of regeneration. What is documented in many studies and testimonials is, that adult stem cell treatment, is well tolerated, with next to no side effects and has helped in many individual cases to improve quality of life. |
These stem cell treatments have nothing in common with the highly manipulated and industrialized produced stem cell products. There are, however, thousands of anecdotal reviews and studies all over the world showing that the use of own stem cell and minimally expanded (Passage 4 to 6) Mesenchymal stem cells from Umbilical cord tissues (Wharton Jelly) have not caused serious side effects, but improved quality of life of many treated.
We acknowledge that this is individual cases and as stem cell clinics provide a personalized treatment with own stem cells the result can vary, except that basically no serious side effects had been reported so far besides the very few politically exploited cases in sensational news reports. |
Aristoloft is cooperating with highly qualified clinics in countries where stem cell treatment is permitted and where many positive results helped patients to improve their health conditions.
DISCLAIMER
As we are embedded in Western regulations, not allowing the promotion of unapproved medicine or medical treatment, we need to draw your attention to our disclaimer, that we are not promoting any unauthorized medicine nor treatments and that any information given in our website had not been reviewed nor approved by FDA / EMA and therefore reflects opinions for educational and informative purpose only.
As we are embedded in Western regulations, not allowing the promotion of unapproved medicine or medical treatment, we need to draw your attention to our disclaimer, that we are not promoting any unauthorized medicine nor treatments and that any information given in our website had not been reviewed nor approved by FDA / EMA and therefore reflects opinions for educational and informative purpose only.
