Stem Cell Tourism
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Stem Cell Tourism
Stem cell tourism, a form of medical tourism, is the internet based-industry in which stem cell procedures are advertised to the public as a proven cure. In the majority of cases, it leads to patients and families traveling abroad to obtain procedures that are not proven, nor part of a clinical trial approved by an authority like the Food and Drug Administration in the United States. These procedures have not gone through the vetting process of clinical research and they lack rigorous scientific support. Although for the general public, this advertising in glossy websites, may sound authoritative, for translational doctors and scientists this leads to the exploitation of vulnerable patients. These procedures lack the reproducibility, the rigor that is required for successful development of new effective medications. Although the term may imply traveling overseas, in recent years, there has been an explosion of "stem cell clinics' in the US which has been well documented. These activi ...
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Medical Tourism
Medical tourism refers to people traveling abroad to obtain medical treatment. In the past, this usually referred to those who traveled from less-developed countries to major medical centers in highly developed countries for treatment unavailable at home. However, in recent years it may equally refer to those from developed countries who travel to developing countries for lower-priced medical treatments. The motivation may be also for medical services unavailable or non-licensed in the home country: There are differences between the medical agencies (FDA, EMA etc.) world-wide which decide whether a drug is approved in their country or not. Even within Europe, although therapy protocols might be approved by the European Medical Agency (EMA), several countries have their own review organizations in order to evaluate whether the same therapy protocol would be "cost-effective", so that patients face differences in the therapy protocols, particularly in the access of these drugs, which mi ...
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Stem-cell Therapy
Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition. , the only established therapy using stem cells is hematopoietic stem cell transplantation. This usually takes the form of a bone-marrow transplantation, but the cells can also be derived from umbilical cord blood. Research is underway to develop various sources for stem cells as well as to apply stem-cell treatments for neurodegenerative diseases and conditions such as diabetes and heart disease. Stem-cell therapy has become controversial following developments such as the ability of scientists to isolate and culture embryonic stem cells, to create stem cells using somatic cell nuclear transfer and their use of techniques to create induced pluripotent stem cells. This controversy is often related to abortion politics and to human cloning. Additionally, efforts to market treatments based on transplant of stored umbilical cord blood have been controversial. Medical uses For over 30 years, ...
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Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not d ...
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International Society For Stem Cell Research
The International Society for Stem Cell Research (ISSCR) is an independent 501(c)(3) nonprofit organization based in Skokie, Illinois, United States. The organization's mission is to promote excellence in stem cell science and applications to human health. History The International Society for Stem Cell Research was formed in 2002 (incorporated on March 30, 2001) to foster the exchange of information on stem cell research. Leonard Zon, professor of pediatrics at Harvard Medical School, served as the organization's first president. In June 2003, the International Society for Stem Cell Research held its first convention. More than 600 scientists attended, many of whom expressed frustration over restrictions that President George W. Bush's administration had placed on the field of stem-cell research, slowing the pace of research. Scientists who were leaders in their fields were prohibited from using funding from the National Institutes of Health to conduct certain experiments tha ...
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Right-to-try Law
Right-to-try laws are U.S. state laws and a federal law that were created with the intent of allowing terminally ill patients access to experimental therapies (drugs, biologics, devices) that have completed Phase I testing but have not been approved by the Food and Drug Administration (FDA). Prior to the passage of right to try laws, patients needed FDA approval to use experimental drugs. As of 2018, 41 U.S. states had passed right to try laws. The framers of these laws argue that this allows for individualized treatments that are not permitted under the FDA's current regulatory scheme. The value of these laws was questioned on multiple grounds, including the fact that pharmaceutical manufacturers would have no obligation to provide the therapies being sought. A federal right to try law was passed in May 2018. Since the signing of the bill thousands of patients have been able to use the experimental therapies. According to Scott Gottlieb, who served as commissioner of the FDA ...
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