Currently Skimming:
3 Patients' Experiences
3 Patients' Experiences
Pages 17-24
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From page 17... ...
Yet some are spending their life savings on treatments that are very unlikely to be effective. Patients who engage in what has become known as stem cell tourism consult with their own physicians before going to a stem cell clinic in their home countries or abroad.
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From page 18... ...
For example, in the United States the FDA regulates such items as drugs, medical devices, and blood and biological products. Though the FDA does not regulate surgical interventions, legal barriers for patients getting experimental surgeries also exist.
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From page 19... ...
Stem cells are living biological products susceptible to genetic instability and do not have the predictability of the small molecules that are used in pills. While some stem cell–based interventions may prove amenable to multistage clinical trial approaches, a surgical or transplantation approach may be more appropriate for others (Hyun, 2010)
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From page 20... ...
Cohen pointed to concerns about the lack of information about both safety and efficacy from treatments that are being performed in these clinics because they are not required to report this information. Treatments done outside the United States raise difficult issues in such areas as fraud, monitoring pediatric patients, and incentives to institute best practices.
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From page 21... ...
Cohen added that countervailing testimony on clinic websites and in patient blogs can also be convincing enough to outweigh warnings about the potential health risks from the treatments. Individual decisions to seek stem cell treatments also occur in a larger political and economic context, Petersen noted.
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From page 22... ...
The first was suspicion about the motives of home country physicians who do not offer these treatments. The second was the fact that some consultation did take place with home country physicians about using Chinese stem cell treatments.
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From page 23... ...
Not being satisfied with his existing options, he began to research promising clinical trials and found the results with autologous stem cell treatments impressive. But the only way to get this type of treatment in the United States is to be in an approved trial.
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From page 24... ...
If research on embryonic stem cells or induced pluripotent stem cells results in new, cell-based, mass-produced products, those products will require regulatory attention, Phelan noted. But autologous stem cell treatment is not something new.
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