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A LETTER TO CONGRESS RE: STEM CELL THERAPY CLINICS

December 19, 2016

A LETTER TO CONGRESS REGARDING STEM CELL THERAPY

 

PLEASE take the time to read through the exerpts below.  If you agree with their conclusions that a group of “stem cell clinics” are victimizing desperate, sick people, please use the enclosed links to gain further information.

Chronic Obstructive Pulmonary Disease, (COPD) is an incurable, progressive disease.  If you can imagine a disabling shortness of breath, an increasing limitation on your activities, you might be able to envision the anguish that would drive lung disease patients to pay many thousands of dollars to an “industry” that is claiming relief using treatments that according to the opinions of many experts, simply cannot work.

In the United States, over 25 milion people have COPD, and many more have other forms of lung disease.    COPD is the third largest killer in the U.S., behind only heart disease and cancer.  Further, it is the only one of the major diseases that is increasing in prevelance.  World-wide, hundreds of millions are affected.  Yet, as the regulations are currently written, the stem cell clinics are able to operate freely and openly. 

Research on stem cell therapy for lung disease is progressing, but estimates from the scientists involved in the research agree that we are still 15 to 20 years from the successful regeneration of lung tissue. 

The advertising by the stem cell clinics is very well done.  It is very encouraging to the lung disease patient and their caregivers.  The trouble arises in the fact that it costs many thousands of dollars, usually comes with a recommendation for additional treatment a year or so later, is not covered by any kind of health insurance, and, again according to the experts quoted below, simply cannot work.

The clinics are currently operating in a grey area of the law.  In the collective opinion of the lung disease organizations quoted below and in the enclosed links, the laws need to be changed and the clinics need to be shut down.  Please review the material and consider acting to protect your constituants from the potential of unimaginable disappointment and financial harm.

 

Thank you so much for your consideration….

 

Signature

 

 

 

 

https://lunginstitute.com/        (From an advertisement for stem cell therapy)

“Through their designated practices, our physicians have gained worldwide recognition for the successful application of revolutionary, minimally invasive stem cell therapies for lung disease. With over a century of combined medical experience, our doctors have established a patient experience designed with the highest concern for patient safety and quality of care. At our world-class facility, we deploy stem cell transplants utilizing autologous stem cells and platelet-rich plasma to promote healing of damaged tissue. Our outpatient stem cell transplant procedures are improving patients’ quality of life and helping them to breathe easier.

 

http://www.closerlookatstemcells.org/stem-cells-and-medicine/nine-things-to-know-about-stem-cell-treatments#.V9lyGl00cLc.facebook

“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 these Nine Things to Know and 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.”

 

A position statement from the COPD Foundation:

http://www.copdfoundation.org/Downloads/COPD-STEM-CELL-POSITION-STMT-FINAL-NOVEMBER-2015.pdf

“It is understandable that people who are desperate might seek any means of improvement or hope of a cure for their condition, even if unproven. This appears to be the promise of autologous stem cell therapy available now. Relying on patient testimonials does not satisfy the statuary requirements for providing proof of efficacy and safety that falls under the purview of the Food and Drug Administration. These testimonials based on patient experience can be misleading to those who are seeking treatment of their COPD. Autologous stem cell therapy may someday fulfill this promise, but there is scant evidence that this therapy will be helpful within the foreseeable future. The COPD Foundation strongly recommends against 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.”

 

A position statement from the American Lung Association:

http://www.lung.org/our-initiatives/research/about-our-research/stem-cell-therapy.html

“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 be able to move toward 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 are strongly concerned that the treatment could cause adverse effects and could worsen the patient's condition.

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. We caution all patients to carefully consider the claims of benefit being made by many of these programs as they have not been substantiated or reviewed by experts in the field or any regulatory agency. We understand that patients may be attracted to these therapies because they have severe irreversible disease and are under great stress. Although we understand this motivation, we still advise against the use of these unproven and often expensive therapies.”

 

An article from the New York Times:

http://www.nytimes.com/2016/07/28/upshot/stem-cell-therapies-are-still-mostly-theory-yet-clinics-are-flourishing.html?_r=0

“Health regulators in the United States are talked about as the best in the world, but a new study on the spread of stem cell clinics shows what can happen when regulations fall behind.

Out of nowhere, over the past two to three years, the clinics have sprung up — 570 in the United States, according to a recent paper — offering untested stem cell treatments for just about every medical use imaginable.

In theory, stem cells might be a useful treatment for certain diseases that involve the loss of cells, like Type 1 diabetes, Parkinson’s or osteoarthritis. They are primitive cells that can develop into a range of mature cells and perhaps serve as replacements. But progress is slow. After a flurry of stem cell excitement two decades ago, almost all the research today is still in mice or petri dishes. The very few clinical trials that have begun are still in the earliest phase.

The problem is that stem cell therapies are still mostly theory. So what is going on? How can there be clinics, even chains of clinics run by companies, offering stem cell treatment for almost any disease you can think of — sports injuries, arthritis, autism, cerebral palsy, stroke, muscular dystrophy, A.L.S., cancer?

An orthopedic clinic, for example, says on its website, “Stem cells actually restore degenerated tissue while providing pain relief.” Another clinic seeks patients with neurological diseases, asserting, “The regenerative nature of the fatty adult stem cells that are extracted from the patient can help improve the degeneration and ease the symptoms associated with the disease.”


The rapid proliferation of stem cell clinics “looks like it is occurring on a nationwide industrial scale,” said Leigh Turner, a bioethicist at the University of Minnesota, who, with Paul S. Knoepfler, a stem cell researcher at the School of Medicine of the University of California, Davis, published the new paper tallying the clinics. “It’s operating brazenly, out in the open. It leaps out of these cultural assumptions about hopes and dreams of stem cell treatment, but there is no science behind it.”

The Food and Drug Administration allows clinics to inject patients with their own stem cells as long as the cells, or the tissue the cells are extracted from, meet specific criteria, including “minimal manipulation,” and are intended to perform their normal basic function.”

 

 

An article from the journal Nature:

http://www.nature.com/news/2011/110628/full/474550a.html

“When stem-cell clinics are asked for documentation about the treatments they offer, some are quick to produce letters from lawyers instead. In the face of legal threats from clinics, the Inter­national Society for Stem Cell Research (ISSCR) has suspended a service intended to help patients wade through claims about therapies. It is now pondering its next move.

For stem-cell researchers, the worldwide proliferation of clinics offering regenerative medicine is frustrating. Many of the treatments such clinics offer — injecting a patient's own stem cells back into his or her body in a bid to treat conditions ranging from Parkinson's disease to spinal-cord injuries — are at best a waste of money, and at worst dangerous. "There's real potential to damage the legitimacy of the field," says Timothy Caulfield, who studies health law and policy at the University of Alberta in Edmonton, Canada.”

 

A warning from the FDA:

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm

“Stem cells, sometimes called the body’s “master cells,” are the precursor cells that develop into blood, brain, bones and all of your organs. Their promise in medical treatments is that they have the potential to repair, restore, replace and regenerate cells that could then be used to treat many medical conditions and diseases.

But the Food and Drug Administration (FDA) is concerned that the hope that patients have for cures not yet available may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.”

 

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