STEM CELLS & THERAPY
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. Hunrdreds 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. Stem cells the repair team of our cellular structure
2. What are stem cells
3. Stem cells, Potency and from where they are harvested
4. Autologous stem cells in medical procedures
5. Stem cells in Veterinary Medicine
6. Dr. A. Caplan - Mesenchymal Stem Cells a scientific update
7. Stem Cell Regulations - FDA and EMA compared to other countries
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. Hunrdreds 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. Stem cells the repair team of our cellular structure
2. What are stem cells
3. Stem cells, Potency and from where they are harvested
4. Autologous stem cells in medical procedures
5. Stem cells in Veterinary Medicine
6. Dr. A. Caplan - Mesenchymal Stem Cells a scientific update
7. Stem Cell Regulations - FDA and EMA compared to other countries
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. 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.
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.
Allogeneic stem cells are harvested also from various tissues of the body mainly from Umbilical Cord tissue and reinjecting 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 stem cell treatment as a medical procedure is not permitted in the USA by its FDA, but some countries have already legalized such procedures. Panama is one of them.
Allogeneic stem cells are harvested also from various tissues of the body mainly from Umbilical Cord tissue and reinjecting 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 stem cell treatment as a medical procedure is not permitted in the USA by its FDA, but some countries have already legalized such procedures. Panama is one of them.
The stem cells performing this regeneration process in our body are called Haematopoietic stem cell and Mesenchymal stem cells. Hamatopoetic 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.
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As we age, the production of stem cells in a human body is not only reduced but also by using those cells for the repair and maintenance of our tissues we, over time, have simply fewer stem cells available in our body to fight the natural wear and tear process of our cellular structure.
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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 repopulate stem cell pool. Some of the well-known sources of MSCs are bone marrow, fat, dental pulp, and umbilical cord tissue.
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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. We have developed a comprehending holistic “maintenance concept” which includes stem cell treatment, and various Complementary and Alternative Medicine, so-called CAM therapies, 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?
2. 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 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.
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.
3. 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 diffentiate 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.aragraph. |
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. 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.
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.
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.
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.
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.
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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 returning it back to the same 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 returning it back to the same 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 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 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.
The allogeneic stem cell treatment method follows 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.
4. Autologous stem cells as an alternative can be easily harvested from the own body.
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The main source had been bone marrow and more recently adipose tissue (fat). The advantage of autologous Stem cells (own) in comparison with Allogeneic Stem Cells (Third party) 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 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.
Furthermore, the costs of this kind of medical treatment are much less than those treatments with patented products, although the medical effect for a patient appears to be the same or similar. |
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In 2022, about 800 clinics in the US are, in one or the other way, still perform mesenchymal stem cell treatment, mainly derived from adipose tissue (fat) from a mini liposuction as a medical procedure. They are all under regulatory and legal "attack" by the FDA, claiming that they are performing unauthorized stem cell treatments, How long they can still 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 agains Cell Surgical Network, allowing the Network to continue treating patients with own, autologous, stem cells as a medical procedure!
Stem cell therapy as a medical procedure from bone marrow fat, containing mesenchymal stem cells are at this moment lesser affected by the FDA regulation in the US, except a clinic would expand those harvested stem cells for its therapeutic performance as a medical procedure. This clearly shows to lack of understanding science by various regulatory bodies protecting the clinical pathway for pharmaceutical drugs.
Human stem cells are natural repair cells of a human body and do not need to be manipulated 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 is changing the nature of stem cells, had been proven 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. Fortunately the FDA in 2022, lost the case agains Cell Surgical Network, allowing the Network to 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.
Stem cell therapy as a medical procedure from bone marrow fat, containing mesenchymal stem cells are at this moment lesser affected by the FDA regulation in the US, except a clinic would expand those harvested stem cells for its therapeutic performance as a medical procedure. This clearly shows to lack of understanding science by various regulatory bodies protecting the clinical pathway for pharmaceutical drugs.
Human stem cells are natural repair cells of a human body and do not need to be manipulated 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 is changing the nature of stem cells, had been proven 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. Fortunately the FDA in 2022, lost the case agains Cell Surgical Network, allowing the Network to 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.
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Scientific reviews and applied autologous stem cell treatments, not only in the cosmetic field, but also in clinics using stem cells in the legal frame of “Practice of Medicine”, have shown that stem cell treatments with autologous stem cells can be considered as safe.
Stem cells isolated from the bone marrow of fat have the ability to become different cell types (i.e. nerve cells, liver cells, heart cells, and cartilage cells). Studies have also shown that these are capable of homing to and repairing damaged tissue. Animal studies have shown that these stem cells also secrete proteins and peptides that stimulate healing of damaged tissue, including heart muscle and spinal cord. Details about the Bone Marrow derived stem cell process you can find in the video next to this text. |
There are many scientific reviews on the safety of using stem cells, One of the more recent reviews of the safety of using mesenchymal stem cells from adipose tissues can be found at the following link. A review of the safety of using mesenchymal stem cells from Bone Marrow showed the same high safety result.
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5. Stem Cells and Veterinary Medicine
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 cllulat therapy.
6. Dr. Arnold Caplan - Stem Cell UPDATE
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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 inflamation, 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”.
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7. Regulations and Stem Cells
When it comes to regulation of stem cells and its therapeutic use there is a wide interpretation what is legally possible and what is not allowed.
First viewpoint, is the ethical concern from where stem cells are harvested. The use of embryonic stem cells resulted in heavy debates about cloning humans, and potentially destroying emerging life for research purposes and had been banned consequently by many countries. The second viewpoint is the protection of consumers as there was an early movement that stem cells can heal everything without any proof. Prove in this context is the prove via clinical trial that the drug is safe and has a positive effect on a human being for a certain condition.
As mentioned before there are two pathways to develop new medicinal products for patients, one is the clinical trial pathway for industrialized produced products intended to be sold at the mass-market to treat a specific symptom and the other pathway is the medical procedure pathway. The pathway used by the industry is, of course, more complex, takes much more time as it is using mainly allogeneic stem cells and often heavily manipulated gene technology or a combination with certain molecules which may trigger certain effects on the cellular structure of a body. It’s a complex procedure but has helped millions of patients especially in the 19 and 20th century to improve quality of life.
First viewpoint, is the ethical concern from where stem cells are harvested. The use of embryonic stem cells resulted in heavy debates about cloning humans, and potentially destroying emerging life for research purposes and had been banned consequently by many countries. The second viewpoint is the protection of consumers as there was an early movement that stem cells can heal everything without any proof. Prove in this context is the prove via clinical trial that the drug is safe and has a positive effect on a human being for a certain condition.
As mentioned before there are two pathways to develop new medicinal products for patients, one is the clinical trial pathway for industrialized produced products intended to be sold at the mass-market to treat a specific symptom and the other pathway is the medical procedure pathway. The pathway used by the industry is, of course, more complex, takes much more time as it is using mainly allogeneic stem cells and often heavily manipulated gene technology or a combination with certain molecules which may trigger certain effects on the cellular structure of a body. It’s a complex procedure but has helped millions of patients especially in the 19 and 20th century to improve quality of life.
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Regulators in many countries, therefore, declared all stem cells as drugs and imposed that treatment with stem cells has to be approved by regulators before given to patients. This concept is clearly valid for heavily manipulated products but when it comes to treatments with own stem cells,i.e. autologous stem cells regulators interpreted this in their own way in accordance with existing regulations.
As mentioned before there are two pathways to develop new medicinal products for patients, one is the clinical trial pathway for industrialized produced products intended to be sold at the mass-market to treat a specific symptom and the other pathway is the medical procedure pathway. The pathway used by the industry is, of course, more complex, takes much more time as it is using mainly allogeneic stem cells and often heavily manipulated gene technology or a combination with certain molecules which may trigger certain effects on the cellular structure of a body. It’s a complex procedure but has helped millions of patients especially in the 19 & 20 Century to improve quality of life. |
Since the introduction of stem cells as drugs a decade ago basically only a handful of highly manipulated stem cell drugs had been approved by the FDA and EMA at prices reaching 1.2 Million Euros per treatment, resulting that most of them had been used only a few times for patients as the insurance companies reviewed each single case due to the very expensive cost associated with such a treatment.
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The medical procedure pathway is an established pathway to help patients with unmet medical needs too and is based on observation of individual patients and the trial to develop a therapy with latest scientific Know How to improve the condition of a singular patient. This approach is often used when mainstream medical procedure could not improve the conditions in such an individual case. This treatment is personalized and according to many countries can be implemented by a physician even as an unproven procedure in case the physician believes the procedure could help the patient in improving quality of life and reduce pain.
There is, however, a strong lobby against this “so-called unproven procedure” as this treatment besides being really personalized, is not following the expensive clinical trial path, to get an approval to be used as a new medicine for human beings.
The argument that autologous (OWN) stem cells are not a drug when used after concentration at the same person, as it is only improving and supporting the natural regeneration process, is not accepted by some regulators in this global medical scenario. Furthermore, regulators claim that those treatments are unproven for specific claims and therefore need to follow when used the clinical trial path.
There is, however, a strong lobby against this “so-called unproven procedure” as this treatment besides being really personalized, is not following the expensive clinical trial path, to get an approval to be used as a new medicine for human beings.
The argument that autologous (OWN) stem cells are not a drug when used after concentration at the same person, as it is only improving and supporting the natural regeneration process, is not accepted by some regulators in this global medical scenario. Furthermore, regulators claim that those treatments are unproven for specific claims and therefore need to follow when used the clinical trial path.
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It appears that this activity is more a political issue than an issue to help patients with early new technological know-how and methods.
Advancement in science, especially medicine and how to implement it, has always divided regulators and medical advocates and politician all over the world.. |
Very often it is however forgotten that such early medical treatment is allowed by basically all countries by the World Medical Association, even the US and EU although the regulations are not well known by the public and interpreted in a way stating that no stem cell treatment is authorized if not specifically approved by authorities!
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As a side effect of this understanding, there are only a few approved, new treatment methods available in Western regulated countries, while other countries have approved new science-driven technologies even though some of those technologies are still in their early exploration state.aph.
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REGULATION & LEGALLY POSSIBLE THERAPIES
In respect of regulation, we like to review the basis of stem cell treatment interpretation of the mostly discussed countries and try to clarify what is legally possible.
THE USA
According to the FDA, all stem cells are drugs and any treatment has to be reviewed and approved before being used in humans. At the same time exist in the CFR 21 -1271 in the HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Regulation the paragraph 15b. stipulating besides others: “You are not required to comply with the requirements of this part if you are an establishment that removes HCT/P’s from an individual and implants such HCT/P’s into the same individual during the same surgical procedure”.
The FDA has issued non-binding guidelines in the last years to limit stem cell treatment as a medical procedure, but as long as 1271 15b, is unchanged stem cell treatment in the US is legally possible if no specific health claims are pursued.
The FDA has issued non-binding guidelines in the last years to limit stem cell treatment as a medical procedure, but as long as 1271 15b, is unchanged stem cell treatment in the US is legally possible if no specific health claims are pursued.
The above overview is the latest (Nov. 2017) review of FDA understanding and interpreting of a medical procedure and fat stem cell. Again like all the other guidelines before, they are still unbinding guidelines at least for the next 3 years, but it shows strongly that the FDA is trying to regulate the nearly 500 stem cell clinics in the US.
it is difficult to say what is the next move by the FDA, certain is only also in 2022, that the FDA has continuesly tried to find ways to stop or regulate so-called unproven stem cell treatments. This therapy is provided via the 1271 15b paragraph allowing stem cell treatment without limitation when it comes to an ambulatory medical treatment with or without IRB approved protocol provided that the cells are minimally manipulated. This term had been redefined in recent years in the frame of FDA recommendations.
it is difficult to say what is the next move by the FDA, certain is only also in 2022, that the FDA has continuesly tried to find ways to stop or regulate so-called unproven stem cell treatments. This therapy is provided via the 1271 15b paragraph allowing stem cell treatment without limitation when it comes to an ambulatory medical treatment with or without IRB approved protocol provided that the cells are minimally manipulated. This term had been redefined in recent years in the frame of FDA recommendations.
THE EUROPEAN UNION
According to EMA, all stem cells are considered as drugs and any treatment has to be reviewed and approved before being used in humans. At the same time exists in paragraph (8) of the statement in DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, that:(8) Tissues and cells used as an autologous graft (tissues removed and transplanted back to the same individual), within the same surgical procedure and without being subjected to any banking process, are also excluded from this Directive. The quality and safety considerations associated with this process are completely different.
From patients advocate point of view both FDA and EMA are exercising an interpretation which has resulted in a very high confusion in this new science-related medical treatment which causes uncertainty, although there are millions of patients already globally treated with own or expanded cord blood tissue-derived stem cells with quite good success and basically now advert events. FDA and EMA are arguing about a few cases which had been registered as adverse event for stem cell treatments not recognizing that according to their own statistics about 200 000 people die, in the USA alone, due to approved drug side effects.
Furthermore, in the EMA regulation it is clearly defined in Directive 2001/83/EC that:
“The scope of this Regulation should be to regulate advanced therapy medicinal products (ATMPs) which are intended to be placed on the market in the Member States and either prepared industrially or manufactured by a method involving an industrial process”. Those industrialized produced ATMPs have to follow the present drug regulation, i.e. it requires a pre-marketing approval.”
From patients advocate point of view both FDA and EMA are exercising an interpretation which has resulted in a very high confusion in this new science-related medical treatment which causes uncertainty, although there are millions of patients already globally treated with own or expanded cord blood tissue-derived stem cells with quite good success and basically now advert events. FDA and EMA are arguing about a few cases which had been registered as adverse event for stem cell treatments not recognizing that according to their own statistics about 200 000 people die, in the USA alone, due to approved drug side effects.
Furthermore, in the EMA regulation it is clearly defined in Directive 2001/83/EC that:
“The scope of this Regulation should be to regulate advanced therapy medicinal products (ATMPs) which are intended to be placed on the market in the Member States and either prepared industrially or manufactured by a method involving an industrial process”. Those industrialized produced ATMPs have to follow the present drug regulation, i.e. it requires a pre-marketing approval.”
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:
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:
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) 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) 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.
