It is hard to Google anything related to COPD, stem cells, or lung transplant without seeing several ads for Stem Cell Therapy Centers. These types of centers have existed for years in other countries, such as Mexico, but now they are appearing in the United States in increasing numbers. Many of them are in Florida or California, and they are now moving into metropolitan Phoenix and other cities.
Any chronic disease can easily lead to desperation, an urgent desire to find some manner of treatment, or even a cure. I have communicated with researchers at Wake Forest, at the University of Boston, at the University of Texas at Galveston and in England, and they all agree that successful treatment of lung disease with stem cells is at least 15 to 20 years away.
I submit the following information and web links from Healthline, from the American Lung Association, from the COPD Foundation, from the FDA, and from the International Society for Stem Cell research. Before you consider paying any clinic for stem cell therapy, please read the remarks from these sites.
A quote from the small print at the bottom of a web page for one of the stem cell therapy clinics:
“All claims made regarding the efficacy of -------------- treatments as they pertain to lung conditions are based solely on anecdotal support collected by ---------------. The treatments, claims, and other information contained on this page and ---------------.com have not been evaluated or approved by the FDA. Any individual that accesses ---------------- website for information is encouraged to speak with his or her primary physician for treatment suggestions and conclusive evidence. All information on this site should be used for educational and informational use only.”
Because the presence of stem cells in the adult lung was confirmed only very recently, there are no stem cell treatments currently available to patients with COPD.
FDA WARNINGS ABOUT STEM CELLS:
Consumers need to be aware that at present—other than cord blood for certain specified indications—there are no approved stem cell products.
Advice for Consumers
· If you are considering stem cell treatment in the U.S., ask your physician if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study. This also applies if the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal.
“There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body,” says Simek. Cells in a different environment may multiply, form tumors, or may leave the site you put them in and migrate somewhere else.
· If you are considering having stem cell treatment in another country, learn all you can about regulations covering the products in that country. Exercise caution before undergoing treatment with a stem cell-based product in a country that—unlike the U.S.—may not require clinical studies designed to demonstrate that the product is safe and effective. FDA does not regulate stem cell treatments used solely in countries other than the United States and typically has little information about foreign establishments or their stem cell products.
Thwarting a Stem Cell Scheme
In December 2011, three men were arrested in the United States and charged with 15 counts of criminal activity related to manufacturing, selling and using stem cells without FDA sanction or approval.
According to the criminal indictment, one of the accused, a licensed midwife who operated a maternity care clinic in Texas, obtained umbilical cord blood from birth mothers, telling them it was for “research” purposes. Instead, the midwife sold the cord blood to a laboratory in Arizona which, in turn, sent the blood to a paid consultant at a university in South Carolina. The owner of the laboratory in Arizona was convicted in August 2011 of unlawfully introducing stem cells into interstate commerce. She faces up to 3 years in prison and a fine of up to $10,000.
The consultant, an assistant professor, used university facilities to manufacture stem cell products. He then sent the products back to the lab, which sold them to a man representing himself as a physician licensed in the U.S. The man then traveled to Mexico to perform unapproved stem cell procedures on people suffering from cancer, multiple sclerosis and other autoimmune diseases.
The three defendants allegedly received more than $1.5 million from patients seeking treatment for incurable diseases.
“Scammers like these offer false hope to people with incurable diseases in order to line their own pockets with money,” says Special Agent in Charge Patrick J. Holland of FDA’s Office of Criminal Investigations (OCI), Kansas City Field Office. “FDA will continue to aggressively pursue perpetrators who expose the American public to the dangers of unapproved stem cells and ensure that they are punished to the full extent of the law.”
FDA’s OCI worked the case with the Federal Bureau of Investigations and the Internal Revenue Service’s Criminal Investigations Division.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Stem cells are immature cells found in a variety of organs including the lungs. Their role is not yet fully understood but there is some evidence that these cells can participate in repair following an injury. The observation that autologous stem cells or stem cells derived from an individual’s own body might possess the ability to repair injured tissues has given hope that these cells might be used to repair the lungs. However, what is not yet understood is exactly how to direct these cells to repair an organ as complex as the lung.
Stem Cell Clinics
Several clinics both within and outside of the United States have been created and promise to use autologous stem cells (such as those from an individual’s fat tissue) to treat a variety of incurable diseases including COPD. These clinics make claims of effectiveness and even cure but none provide direct scientific proof. In addition the US Food and Drug Administration has not approved this therapy to treat COPD.
COPD Foundation Position
Autologous stem cell therapy is not currently recommended for the treatment of COPD. The COPD Foundation does not recommend the use of autologous stem cell therapy in the treatment of COPD or other lung disease until there is more rigorous scientific and medical proof of its effectiveness. Instead the COPD Foundation encourages individuals to participate in clinical trials that test the development and potential benefit of this technique.
AMERICAN LUNG ASSOCIATION:
Statement on Stem Cells and Cell Therapies for Lung Diseases
The use of stem cells for treating lung diseases has great appeal. As we learn more about the therapeutic potential of stem cells and other cell therapies in clinical trials of non-lung diseases, we hope to move towards further consideration of these Approaches in lung diseases.
However, as yet, there is very little known about the short and long term effects of administering any type of stem cell therapy to patients with lung diseases. Until we know more, we must be strongly concerned that the treatment could cause adverse effects and could worsen the patient’s condition rather than improve it. As such, safety must be the top priority.
At present, there are only a small number of approved clinical trials in the United States and Canada investigating cell therapy approaches for lung diseases. These can be found on the website of the National Institutes of Health at www.clinicaltrials.gov. We are hopeful that there will be more in the future.
However, you may come across information on the internet or other sources about stem cells being administered to patients with lung diseases, such as emphysema, pulmonary hypertension or pulmonary fibrosis. These trials may be listed as occurring either in the US or in other countries. We caution all patients to carefully consider the claims of benefit being made by many of these programs as they have not been substantiated nor have they been reviewed by experts in the field or any regulatory agency. Because of the potential for harm, the lack of any proven benefit, and the high fees that many of these programs charge, we caution you not to participate in these or any other comparable unauthorized or unapproved stem cell administrations, unless independent credible, reliable, and objective sources of information are available to substantiate the information and claims being made.
One such reliable source of information, endorsed by the American Lung Association, is the International Society for Stem Cell Research (ISSCR). The ISSCR has developed an excellent web-based resource, ‘A Closer Look at Stem Cell Treatments’, to educate individuals on evaluating claims made by various organizations offering stem cell therapies. We strongly recommend reviewing the ISSCR website at www.closerlookatstemcells.org.
The International Society for Stem Cell Research
Top Ten Things to Know About Stem Cell Treatments
Many clinics that are offering stem cell treatments make claims about what stem cells can and cannot do that are not supported by our understanding of science. The information on this page corrects some of the misinformation that is being widely circulated.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Many clinics offering stem cell treatments make claims that are not supported by a current understanding of science
Stem cells have tremendous promise to help us understand and treat a range of diseases, injuries and other health-related conditions. Their potential is evident in the use of blood stem cells to treat diseases of the blood, a therapy that has saved the lives of thousands of children with leukemia; and can be seen in the use of stem cells for tissue grafts to treat diseases or injury to the bone, skin and surface of the eye. Important clinical trials involving stem cells are underway for many other conditions and researchers continue to explore new avenues using stem cells in medicine.
There is still a lot to learn about stem cells, however, and their current applications as treatments are sometimes exaggerated by the media and other parties who do not fully understand the science and current limitations, and also by “clinics” looking to capitalize on the hype by selling treatments to chronically ill or seriously injured patients. The information on this page is intended to help you understand both the potential and the limitations of stem cells at this point in time, and to help you spot some of the misinformation that is widely circulated by clinics offering unproven treatments.
It is important to discuss …….. any research or information you gather with your primary care physician and other trusted members of your healthcare team in deciding what is right for you.
Here is a rather interesting blog on the subject of the FDA and stem cell clinics…..The list of diseases for which stem cell treatments have been shown to be beneficial is still very short. The best-defined and most extensively used stem cell treatment is hematopoietic (or blood) stem cell transplantation, for example, bone marrow transplantation, to treat certain blood and immune system disorders or to rebuild the blood system after treatments for some kinds of cancer.Some bone, skin and corneal (eye) injuries and diseases can be treated by grafting or implanting tissues, and the healing process relies on stem cells within this implanted tissue. These procedures are widely accepted as safe and effective by the medical community. All other applications of stem cells are yet to be proven in clinical trials and should be considered highly experimental.Beware of stem cell treatments offered without regulatory approval or outside the confines of a legitimate and registered clinical trial.
It can be hard to tell the difference between doctors conducting responsible clinical trials and clinics selling unproven treatments. One common differentiator is the way a treatment is marketed. Most specialized doctors receive patient referrals, while clinics selling stem cell treatments tend to market directly to patients, often through persuasive language on the Internet, Facebook and in newspaper advertisements.
Clinics peddling unproven stem cell treatments frequently overstate the benefits of their offerings and use patient testimonials to support their claims. These testimonials can be intentionally or unintentionally misleading. For example, a person may feel better immediately after receiving a treatment, but the perceived or actual improvement may be due to other factors, such as an intense belief that the treatment will work, auxiliary treatments accompanying the main treatment, healthy lifestyle changes adapted in conjunction with the treatment and natural fluctuations in the disease or condition. These factors are complex and difficult to measure objectively outside the boundaries of carefully designed clinical trials. Learn more about why we need to perform clinical trials here.
Beware of clinics that use persuasive language, including patient testimonials, on the Internet, Facebook and newspapers, to market their treatments, instead of science-based evidence.
The fact that a procedure is experimental does not automatically mean that it is part of a research study or clinical trial. Responsible clinical trials share several important features:
·They build upon their own preclinical data, lab-based research on cells, tissues and animals, that indicates the treatment being tested is likely to be safe and effective
·Oversight by an independent medical ethics committee to protect participants’ rights
·Conformity to regulatory requirements, including a listing in a recognized clinical trial registry
·A structure designed to answer specific questions about a new treatment or a new way of using current treatments (results are usually compared with a control group of patients who do not receive the experimental treatment)
·The cost of the new treatment and monitoring is not covered by the participant
Responsibly-conducted clinical trials are critical to the development of new treatments. Learn more about clinical trials here.
Beware of expensive treatments that have not passed successfully through clinical trials.