tag:blogger.com,1999:blog-2186593343917545414.post7457249713341387625..comments2024-03-10T12:29:30.004-07:00Comments on pediatric neurology: Stem cell tourismGalen Breningstall, MDhttp://www.blogger.com/profile/07170864203251456228noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-2186593343917545414.post-72767795852948878562016-07-25T15:44:01.568-07:002016-07-25T15:44:01.568-07:00Turner L, Knoepfler P. Selling Stem Cells in the U...Turner L, Knoepfler P. Selling Stem Cells in the USA: Assessing the<br />Direct-to-Consumer Industry. Cell Stem Cell. 2016 Jun 29.<br /><br />Abstract<br />Direct-to-consumer marketing of unapproved stem cell interventions is a well-known phenomenon in countries with lax medical regulations. However, an examination of Internet-based marketing claims revealed widespread promotion of such interventions by businesses based in the United States. Such commercial activity suggests that regulatory agencies must better oversee this marketplace.<br /><br />Turner L. US stem cell clinics, patient safety, and the FDA. Trends Mol Med. 2015 May;21(5):271-3.<br /><br />Abstract<br />Scholarship on patients accessing unproven stem cell interventions is dominated by research addressing 'stem cell tourism' to such countries as China, India, Mexico, and the Ukraine. However, clinics marketing 'adipose-derived mesenchymal stem cell treatments' are proliferating across the USA. These businesses typically claim to operate in compliance with federal regulations, but careful review of their commercial practices suggests that such clinics are marketing unapproved and noncompliant biological drugs.Galen Breningstall, MDhttps://www.blogger.com/profile/07170864203251456228noreply@blogger.comtag:blogger.com,1999:blog-2186593343917545414.post-65294173186544954452016-07-25T14:53:10.805-07:002016-07-25T14:53:10.805-07:00While the case report did not identify the patient...While the case report did not identify the patient, the man disclosed his identity to the media. In an interview with the New York Times, Jim Gass of San Diego, said he searched the Internet and spent close to $300,000 for treatments and travel costs in the hopes of reversing lingering damage from a 2009 stroke. The article said the spine tumor left him far worse off — “paralyzed from the neck down, except for his right arm,” and the tumor is still growing.<br /><br />The doctors described the case as “stem cell tourism” gone awry.<br /><br />“This case and others in which tumors have developed in the context of stem-cell tourism...illustrate an extremely serious complication of introducing proliferating stem cells into patients,” they wrote. They noted, in contrast, that stem cell researchers working on new therapies utilize techniques that “reduce the risk of stem-cell-related tumors in clinical trials by means of the measured administration of pluripotent stem cells or by differentiating stem cells in vitro into postmitotic phenotypes before administration.”<br /><br />“The unregulated commercial stem-cell industry is not only potentially harmful to individuals, but also undermines attempts to study stem-cell therapies in clinical trials,” the doctors noted...<br /><br />While the man in the case report sought out treatment in other countries, there are many commercial stem cell clinics popping up around the United States. A study in the June 30 online edition of Cell Stem Cell found that there are 571 so-called stem cell clinics operated by 351 businesses around the country. [Neurology Today reported on unregulated stem cell clinics in the US last year. See “Unregulated Stem Cell Clinics Proliferate in the US, Despite 2013 Court Ruling”: http://bit.ly/stemcells-NT.]Such clinics in the US and abroad advertise treatments for everything from achy joints to sagging faces to neurologic conditions such as Alzheimer's disease, amyotrophic lateral sclerosis (ALS), and Parkinson's disease...<br /><br />“Stem cells have the characteristic ability to self-renew or replicate,” meaning it is possible that a tumor could arise from the proliferating cells. These are potentially dangerous cells to administer to the patient, especially in the central nervous system,” he said.Clive Svendsen, PhD, a stem cell researcher at Cedars-Sinai David Geffen School of Medicine at the University of California, Los Angeles, said the case illustrates the serious unintended consequences that can occur when investigational therapies are administered outside the safety net of government regulations and peer review. Besides such tumors, there could be infection or a dangerous immune response.<br /><br />http://journals.lww.com/neurotodayonline/Fulltext/2016/07210/When_a_Stroke_Patient_Gets_Worse_after_Stem_Cell.1.aspxGalen Breningstall, MDhttps://www.blogger.com/profile/07170864203251456228noreply@blogger.com