|
We welcome you to our fourth edition of the Stem-Cell-Treatment-NOW.com newsletter on stem cells therapies. If you have any questions about our stem cell treatments, please direct inquiries to: MD@stemtechlab.com
If you like to read our previous newsletter click here
Our newsletters offer you information about the human umbilical stem cell treatments we offer.
Contents
ARTICLES:
• Top Ten Things to Know About Stem Cell Treatments
• A rebuttal to ISSCR
The International Society for Stem Cell Research (ISSCR) is a self-appointed group of so-called experts in stem cell research. These “experts” are heavily into the standard disease-oriented medical paradigms of using stem cells to create, with lots of expensive and proprietary research, patentable drugs which are targeted toward specific, limited disease treatments. They cannot stand the idea that a natural, unmodified treatment exists to help alleviate anything. (see the ISSCR page How Science Becomes Medicine.) They consider cord blood-derived stem cells only as a source for replacing bone marrow cells following treatment with cellular poisons and radiation, and pointedly ignore any possibility of using neonatal stem cells for any other condition.
In 2008 ISSCR created a list of guidelines for stem cell therapies and research http://www.isscr.org/clinical_trans/index.cfm which unilaterally set themselves up as world police for stem cell research, and effectively denied any role for the years of private research and experience in neonatal stem cell therapy in the world of regulated medicine.
ISSCR now continues their propaganda against unmodified stem cells by publishing a new website that is purported to “protect vulnerable patients from unscrupulous foreign stem cell clinics”. While there is some truth in this website, there is a lot of misinformation and deliberate deletion and skewing of the facts.
In particular, we would like to address point by point the “Top Ten Things” that they want patients to know about stem cell treatment—ultimately, that they don’t exist, yet, but that the scientists who make up their ranks are working on those patents as we speak! Here are the ten points from their website:
http://www.closerlookatstemcells.org/Top_10_Stem_Cell_Treatment_Facts.htm and our rebuttals:
1. There are different types of stem cells—each with their own purpose.
There are many different types of stem cells that come from different places in the body or are formed at different times in our lives. These include embryonic stem cells that exist only at the earliest stages of development and various types of ‘tissue-specific’ or ‘adult’ stem cells that appear during fetal development and remain in our bodies throughout life.
Our bodies use different types of tissue-specific stem cells to fit a particular purpose. Tissue-specific stem cells are limited in their potential and largely make the cell types found in the tissue from which they are derived. For example, the blood-forming stem cells (or hematopoietic stem cells) in the bone marrow regenerate the blood, while neural stem cells in the brain make brain cells. A neural stem cell won’t spontaneously make a blood cell and likewise a hematopoietic stem cell won’t spontaneously make a brain cell. Thus, it is unlikely that a single cell type could be used to treat a multitude of unrelated diseases that involve different tissues or organs. Be wary of clinics that offer treatments with stem cells that originate from a part of the body that is different from the part being treated.
Read more about different Types of Stem Cells
RESPONSE: Yes, it is true that there are many different kinds of stem cells. And it is true that the blood will not SPONTANEOUSLY make a brain cell, at least not in a Petri dish. But there are several very important things that this article ignores, such as:
• Stem cells capable of converting into many different kinds of cells are called “multipotent”. Both of the stem cell types used by StemTech Labs are multipotent stem cells. This concept is totally ignored in this explanation.
• The mesenchymal and hematopoietic stem cells found in cord blood easily convert into neural (nerve and brain) stem cells. In fact, one of the early tests for stem cells was to see if they could turn into neural stem cells!
• Mesenchymal cells WILL turn into brain cells, and have been demonstrated to do so!
Many clinicians have seen marked improvement in brain-damaged stroke and cerebral palsy patients after stem cell treatments.
• Mesenchymal cells will turn into specialized brain cells, such as the dopamine-producing cells that are affected in Parkinson’s disease, and this has been conclusively demonstrated in animal models.
• In fact, mesenchymal stem cells have been converted in the laboratory into bone, fat, blood, nerve, cartilage, connective tissue, several kinds of brain cells, liver, kidney, lung, pancreatic islet (insulin-producing), smooth muscle, skeletal muscle, heart muscle, and other types of stem cells and tissue cells. These tissues represent ALL THREE EMBRYONIC LAYERS from which all of the cells iin the body are formed.
• http://content.karger.com/ProdukteDB/produkte.asp?Doi=124281 Gimble JM, Guilak F, Nuttall ME, Sathishkumar S, Vidal M, Bunnell BA: In vitro Differentiation Potential of Mesenchymal Stem Cells. Transfus Med Hemother 2008;35:228-238 (DOI: 10.1159/000124281)
Why is this being ignored by these so-called “experts”?
While this article says that it is unlikely that a single cell type could be used to treat a multitude of unrelated diseases that involve different tissues or organs, Geron corporation is currently conducting FDA-approved stem cell studies as well as pre-clinical trials on a variety of disease types, involving: Spinal Cord, Lung, Cartilage, Heart, and Diabetes, all derived from a single stem cell line. www.geron.com.
“Be wary of clinics that offer treatments with stem cells that originate from a part of the body that is different from the part being treated.”—You mean, like bone marrow being treated with blood stem cells (as in dozens of hospitals around the world, over the last 20 years), or joints, lungs, heart, pancreas all being treated by umbilical cord or adult bone marrow cells? Hogwash!!!!
2. A single stem cell treatment will not work on a multitude of unrelated diseases or conditions.
As described above, each type of stem cell fulfills a specific function in the body and cannot be expected to make cell types from other tissues. Thus, it is unlikely that a single type of stem cell treatment can treat multiple unrelated conditions, such as diabetes and Parkinson’s disease. The underlying causes are very different and different cell types would need to be replaced to treat each condition. It is critical that the cell type used as a treatment be appropriate to the specific disease or condition.
Embryonic stem cells may one day be used to generate treatments for a range of human diseases. However, embryonic stem cells themselves cannot directly be used for therapies as they would likely cause tumors and are unlikely to become the cells needed to regenerate a tissue on their own. They would first need to be coaxed to develop into specialized cell types before transplantation. A major warning sign that a clinic may not be credible is when treatments are offered for a wide variety of conditions but rely on a single cell type.
RESPONSE: More of the same type of distortion. Notice that they do recognize that embryonic stem cells are not safe for human use—the embryonic cells cause tumors 10% of the time when used in lab animals. But Geron’s spinal cord treatment “drug” www.geron.com IS being used on humans, IS embryonic in origin, and IS under FDA-approved studies. Why is it allowed? Because it is patentable, and is modified from a natural state, so that it is called and treated as a DRUG. That is what the system wants, not a naturally occurring, unpatentable treatment that works on many different disorders.
We agree that embryonic stem cells “first need to be coaxed to develop into specialized cell types before transplantation.” But what about neonatal stem cells, like the ones that StemTech uses—notice that nothing is said about them! And they do not need to be modified, or “coaxed to develop into specialized cell types”. Neonatal stem cells already have this capacity, and have demonstrated it in the lab. And they have already shown repeated beneficial effects for a wide variety of conditions in NON-USA countries, a fact conveniently and pointedly ignored by the so-called “experts”, who first deny the privilege of publishing these findings in their journals, and then scoff at the research because it is not published! A convenient Catch-22 for them to use.
Actually, one of the problems that we have in our neonatal stem cell therapy is that the stem cells DO treat many different conditions! In fact, the more different conditions a patient has, the more cells it takes to treat him! This is because the cells first go to treat the most acute conditions, and only later go to work on the more chronic conditions that may be the most important. It is a shame to waste precious stem cells on a cold, cut finger or bladder infection, when we really want them to heal the brain!
3. Currently, there are very few widely accepted stem cell therapies.
The range of diseases where stem cell treatments have been shown to be beneficial in responsibly conducted clinical trials is still extremely restricted. The best defined and most extensively used is blood stem cell transplantation to treat diseases and conditions of the blood and immune system, or to restore the blood system after treatments for specific cancers. Some bone, skin and corneal diseases or injuries can be treated with grafting of tissue that depends upon stem cells from these organs. These therapies are also generally accepted as safe and effective by the medical community.
RESPONSE: This reflects again the medical disease-oriented paradigm—that a specific treatment can be used only for a specific disorder. It also reflects the fact that the research done in non-USA countries is ignored by the drug-oriented Big Pharma/BioTech/FDA complex. “Widely accepted stem cell therapies” are only widely accepted because they are specific and disease-focused. All other research need not apply.
4. Just because people say stem cells helped them doesn’t mean they did.
There are three main reasons why a person might feel better that are unrelated to the actual stem cell treatment: the ‘placebo effect’, accompanying treatments, and natural fluctuations of the disease or condition. The intense desire or belief that a treatment will work can cause a person to feel like it has and to even experience positive physical changes, such as improved movement or less pain. This phenomenon is called the placebo effect. Even having a positive conversation with a doctor can cause a person to feel improvement. Likewise, other techniques offered along with stem cell treatment—such as changes to diet, relaxation, physical therapy, medication, etc.—may make a person feel better in a way that is unrelated to the stem cells. Also, the severity of symptoms of many conditions can change over time, resulting in either temporary improvement or decline, which can complicate the interpretation of the effectiveness of treatments. These factors are so widespread that without testing in a controlled clinical study, where a group that receives a treatment is carefully compared against a group that does not receive this treatment, it is very difficult to determine the real effect of any therapy. Be wary of clinics that measure or advertise their results primarily through patient testimonials.
RESPONSE: We are certainly not going to deny the power of the placebo effect. The mind-body effect, in fact, deserves more attention than it usually gets. And while we do not argue with most of the statements in this paragraph, it also seems to us rather paternal—“There, there, we are the experts, and though you may THINK that you are feeling better, we know that stem cells could not be responsible, and so therefore it is all in your mind.”
On the contrary, we have also observed that some patients who have received stem cells have reported little improvement, while their family members report that the patient has a better mood, more mobility, more energy, better quality of life. Certainly the evaluation of an individual patient can be distorted, and a well designed and operated clinical trial should be better able to reveal any changes.
5. A large part of why it takes time to develop new therapies is that science itself is a long and difficult process.
Science, in general, is a long and involved process. Understanding what goes wrong in disease or injury and how to fix it takes time. New ideas have to be tested first in a research laboratory, and many times the new ideas don’t work. Even once the basic science has been established, translating it into an effective medical treatment is a long and difficult process. Something that looks promising in cultured cells may fail as a therapy in an animal model and something that works in an animal model may fail when it is tried on humans. Once therapies are tested in humans, ensuring patient safety becomes a critical issue and this means starting with very few people until the safety and side effects are better understood.
If a treatment has not been carefully designed, well studied and gone through the necessary preclinical and clinical testing, it is unlikely to have the desired effect. Even more concerning is that it may prove to make the condition worse or have dangerous side effects.
See How Science Becomes Medicine
RESPONSE: Again, this demonstrates the bias of this group towards high-tech, patentable, no longer natural treatments, and against the use of unmodified neonatal stem cells, which is totally ignored.
6. To be used in treatments, stem cells will have to be instructed to behave in specific ways.
Bone marrow transplantation is typically successful because we are asking the cells to do exactly what they were designed to do, make more blood. For other conditions, we may want the cells to behave in ways that are different from how they would ordinarily work in the body. One of the greatest barriers to the development of successful stem cell therapies is to get the cells to behave in the desired way. Also, once transplanted inside the body the cells need to integrate and function in concert with the body’s other cells. For example, to treat many neurological conditions the cells we implant will need to grow into specific types of neurons, and to work they will also have to know which other neurons to make connections with and how to make these connections. We are still learning about how to direct stem cells to become the right cell type, to grow only as much as we need them to, and the best ways to transplant them. Discovering how to do all this will take time. Be wary of claims that stem cells will somehow just know where to go and what to do to treat a specific condition.
RESPONSE: Again, this demonstrates the bias of this group towards high-tech, patentable, no longer natural treatments, and against the use of unmodified neonatal stem cells, which is totally ignored. These so-called “experts” ignore the inherent intelligence of the cells, which are able to migrate to different areas of the body (“chemotaxis”) and then stimulate and participate in repair processes.
Do you think that these “experts” could imagine that a cut finger would be able to repair itself, without the application of patented antibiotics and growth factors to the wound?
7. Just because stem cells came from your body doesn’t mean they are safe.
Every medical procedure has risks. While you are unlikely to have an immune response to your own cells, the procedures used to acquire, grow and deliver them are potentially risky. As soon as the cells leave your body they may be subjected to a number of manipulations that could change the characteristics of the cells. If they are grown in culture (a process called expansion), the cells may lose the normal mechanisms that control growth or may lose the ability to specialize into the cell types you need. The cells may become contaminated with bacteria, viruses or other pathogens that could cause disease. The procedure to either remove or inject the cells also carries risk, from introducing an infection to damaging the tissue into which they are injected.
RESPONSE: Gee, what a fear-inspiring heading! Seems kind of ridiculous, doesn’t it? While I do not believe that adult bone marrow stem cells are the best kind of stem cells to use for many conditions, it seems silly to me that if you take cells from the bone marrow and then inject them back into the blood, that it would be dangerous! Certainly there are people who believe that taking blood out from their own body and then reinjection it is sinful, but there is little inherent risk.
I do agree that harvesting the cells and then expanding them are without risks, but it is not the stem cells that are the problem with the harvesting procedure, it is the doctor who is the risk!
According to FDA regulations, expansion of any stem cells turns it into a drug, and it cannot be used in interstate commerce. That is why StemTech does not provide expanded mesenchymal stem cells to the USA. Fortunately, most of the doctors doing this adult stem cell expansion keep the cells in their own office, or at least their own state, which legally removes them from FDA jurisdiction (though the FDA usually chooses to ignore this exemption in the law).
8. There is something to lose by trying an unproven treatment.
Some of the conditions that clinics claim are treatable with stem cells are considered incurable by other means. It is easy to understand why people might feel they have nothing to lose from trying something even if it is unproven. However, there are very real risks of developing complications, both immediate and long-term, while the chance of experiencing a benefit is likely very low. In one publicized case, a young boy developed brain tumors as a result of a stem cell treatment. Participating in an unproven treatment may make a person ineligible to participate in upcoming clinical trials (see also number 9). Where cost is high, there may be long-term financial implications for patients, their families and communities. If travel is involved there are additional considerations, not the least of which is being away from family and friends.
RESPONSE: I do not disagree with most of the statements in this paragraph. I would like to point out that the boy who developed the tumors was given embryonic or fetal stem cells, which are recognized to cause tumors frequently. There are complications with any medical procedure, and it is wise to find out the kinds of complications that could occur, and their likelihood. Of course, there is a definite risk of continued loss of function and loss of quality of life without treatment, and this is likely much higher than the risk of the procedure or its complications! Patients and their families should research the options to the best of their abilities.
I should comment on the term “unproven treatment”. Some things that are considered standard of care in other countries are considered quackery by the FDA. For example, in some countries, before a cardiac bypass is provided by the government, a course of EDTA chelation therapy is mandated. Only if the EDTA chelation fails is the bypass approved. But in the USA, after decades of studies showing its safely and effectiveness, chelation therapy is still not accepted by the medical establishment.
Standards of “proof” depend on the mindset of the agency that pronounces “proof”. Most medical procedures, and most drugs over 50 years old, have never been “proven” according to currently accepted criteria. Some of the most famous procedures which lack proof of effectiveness include coronary artery bypass, which is no more effective than placebo in well organized clinical trials. But, hospitals make way too much money on bypass operations, so this fact is ignored. Treatment of influenza with ozone, hydrogen peroxide, or high dose vitamin C are clinically proven, but too much outside of the realm of possibilities for most doctors to accept them as other than an “unproven” therapy.
9. An experimental treatment offered for sale is not the same as a clinical trial.
The fact that a procedure is experimental does not automatically mean that it is part of a research study or clinical trial. A responsible clinical trial can be characterized by a number of key features. There is preclinical data supporting that the treatment being tested is likely to be safe and effective. Before starting, there is oversight by an independent group such as an Institutional Review Board or medical ethics committee that protect patients’ rights, and in many countries the trial is assessed and approved by a national regulatory agency, such as the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA). The study itself is designed to answer specific questions about a new treatment or a new way of using current treatments, often with a control group to which the group of people receiving the new treatment is compared. Typically, the cost of the new treatment and trial monitoring is defrayed by the company developing the treatment or by local or national government funding. Beware of expensive treatments that have not passed successfully through clinical trials.
Responsibly-conducted clinical trials are critical to the development of new treatments as they allow us to learn whether these treatments are safe and effective. The ISSCR supports participation in responsible clinical trials after careful consideration of the issues highlighted on this site and in discussion with a trusted physician.
For more information on clinical trials work click here.
RESPONSE: This information is basically valid. A few problems in this system are:
Lack of recognition of clinical trials done outside of the USA. I tried for years to get some high-quality German research for a highly effective allergy and asthma treatment recognized by the FDA. Because it was not done in the US, the FDA would not even look at it.
Unwillingness of US doctors to risk their licenses by becoming involved in clinical trials of “unorthodox” treatments. There is plenty of opportunity and willingness to become involved in DRUG trials, but local medical boards look askance at doctors involved in trials of non-pharmaceutical treatments.
Control of medical journals by Big Pharma. If you took a medical journal such as JAMA and removed all the drug ads, you would have only a few pages left. Drugs pay for journals, drugs pay for medical education, medical school, post-graduate education, and continuing medical education. Medical journals are not likely to accept even quality research done for low cost treatments that treat a variety of conditions, because of editorial conflicts. Thus, research is not published, and remains unrecognized and “unproven”.
10. Stem cell science is constantly moving forward.
Stem cell science is extraordinarily promising. There have been great advances in treating diseases and conditions of the blood system using blood-forming stem cells, and these show us just how powerful stem cell therapies can be. Scientists all over the world are researching ways to harness stem cells and use them to learn more about, to diagnose, and to treat various diseases and conditions. Every day scientists are working on new ways to shape and control different types of stem cells in ways that are bringing us closer to developing new treatments. Many potential treatments are currently being tested in animal models and some have already been brought to clinical trials. In February 2010 the British company ReNeuron announced it had been approved to conduct a Phase I clinical trial of a neural stem cell treatment for stroke. The first embryonic stem cell-based treatment for acute spinal cord injury has been authorized by the U.S. Food and Drug Administration (FDA) to move into Phase I clinical trials. Although it is sometimes hard to see, stem cell science is moving forward. We are tremendously optimistic that stem cell therapies will someday be available to treat a wide range of human diseases and conditions.
RESPONSE: Again, this ignores currently available non-modified stem cell therapies, and promises that “some day” stem cell therapies, highly modified, from embryonic cells, converted into drugs, patentable and extremely expensive MIGHT be available for your condition. Stem cells need to be “harnessed”—they couldn’t possibly be intelligent enough to do anything without the intervention of the Mighty Gods of Science!
And did you notice that even those lauded “great advances in treating diseases and conditions of the blood system using blood-forming stem cells” use UNMODIFIED, UMBILICAL CORD BLOOD-DERIVED stem cells. The same ones that we produce. But did they say that? Did they say anything about neonatal stem cells? Nope. They don’t exist, or if they do, they are not worth mentioning. Not by these so-called “experts”.
We wish you light and knowledge in your search.
Dan L. Ecklund, MD
|
