FDA warns against stem cell treatments in hotels, non-health facilities

After receiving complaints on the matter, Philippine health authorities warned the public, especially tourists visiting the country for "medical needs," against receiving stem-cell therapies in hotels and other non-health facilities. The Philippine Food and Drug Administration warned those getting such treatments in non-health facilities risks contraction of an infectious disease and severe complications. "The public is warned against receiving stem cell preparations and therapies without prior regulatory applications and approval from the Food and Drug Administration, Department of Health," it said in Advisory No. 2013-012. It said the following stem cell preparations require FDA approval: - Genetically altered human adult and umbilical cord stem cells - Adipose or fat cells derived human stem cell - Human cells, tissues, and cellular and tissue-based products subjected to genetic manipulation - Live animal embryonic, fetal, or adult stem cells in parenteral form for human administration. The FDA stressed it "does not allow the creation, importation, promotion, marketing and use of human embryos, human embryonic stem cells and their derivatives, aborted human fetal stem cells and their derivatives for human treatment and research, as well as plant parts labeled as stem cells." It advised patients to consult only with duly-licensed medical practitioners who practice stem cell therapy, and in health facilities approved by the DOH. Also, it urged patients to verify with the FDA through email,(info@fda.gov.ph) before undergoing a procedure. Meanwhile, those suffering from "adverse" results or those with complaints may avail of the FDA's eReport facility at www.fda.gov.ph. — DVM, GMA News