FDA warns vs stem cell therapy

MANILA, Philippines - The Food and Drug Administration (FDA) yesterday warned that it has received numerous complaints from health experts and the public that unregistered stem cell preparations and therapies are being provided in hotels and other non-health facilities.

The FDA has advised the public, particularly foreign tourists visiting the Philippines for leisure or for medical reasons, to ensure that the stem cell preparations and therapies they will use are approved by the health agency.

The FDA said patients who use unregistered stem cell preparations and therapies are at risk of acquiring infectious disease resulting in deadly complications.

Unregistered stem cell preparations can lead to permanent disability, physical deformities and death without the benefit of health insurance coverage.

Stem cell preparations such as genetically altered human adult and umbilical cord stem cells, and adipose or fat cells-derived human stem cell require FDA approval.

Use of human cells, tissues, and cellular and tissue-based products that are subjected to genetic manipulation, as well as live animal embryonic, fetal, or adult stem cells in parenteral form for human administration also need FDA approval.

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.

The FDA urged the public to consult only with duly licensed medical practitioners who conduct stem cell therapy in health facilities approved by the Department of Health.

Patients are also encouraged to verify with the FDA Philippines before undergoing the procedure by accessing the agency’s site at [email protected].

Those who suffer from adverse effects or complications may also report to FDA’s eReport facility at www.fda.gov.ph.