THE Food and Drugs Administration (FDA) on Tuesday warned the public against receiving stem-cell therapies in hotels and other unauthorized facilities as this may lead to contraction of infectious diseases.
Dr. Kenneth Hartigan-Go, FDA acting director said that they have received reports that some high-class hotels and wellness centers have been offering stem-cell procedures and other “medical needs” at their establishments to affluent people, especially tourists.
In its Advisory No. 2013-012, FDA noted that stem-cell preparations that need FDA approval are the 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; and live animal embryonic, fetal, or adult stem cells in parenteral form for human administration.
He said availing of such treatments in non-health facilities may lead to contraction of infectious diseases and other complications as such delicate procedures require strict FDA approval.
“The public is warned against receiving stem cell preparations and therapies without prior regulatory applications and approval from the Food and Drug Administration,” Go said.
He also said that FDA 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.
“Patients should only consult with duly-licensed medical practitioners who practice stem cell therapy, and in health facilities approved by the DOH,” Go said.
To avoid any health risk, Go urged patients to verify first with the FDA, through its e-mail firstname.lastname@example.org if the facility offering such treatments have the agency’s clearance.
Stem-cell therapy is an intervention strategy that introduces new adult stem cells into damaged tissue in order to treat disease or injury, which many medical experts believe treats certain illness and slows down aging among human.
The treatment is being practiced in foreign countries such as China, Ukraine, Mexico, South Korea, and Middle East and Africa.