DOH bans genetically altered stem cells

MANILA, Philippines - The Department of Health (DOH) has banned the use of genetically altered stem cells and tissues of human adults in its implementing rules and regulations (IRR) on stem cell therapy issued yesterday.

The IRR restricts the use of “genetically altered stem cells and tissues of human adults and the umbilical cord, fat-derived human stem cells, and live animal stem cells.”

The DOH issued the guidelines to govern the practice of stem cell therapy in the country. It said the use of certain stem cells is deemed unsafe and ineffective.

“Our efforts at regulating the practice of stem cell therapy in this country are aimed at safeguarding the welfare of our patients and the general public by making safe, effective and ethical stem cell modalities and practices within emerging international and global standards considering the very complex nature of this therapy,” Health Secretary Enrique Ona said.

The DOH also issued the administrative order governing the accreditation of health facilities engaging in human stem cell and cellular therapies in the country. It ordered the creation of the Bioethics Advisory Board that will regulate stem cell treatment in the country.

“The AO...is aimed at ensuring that human stem cell and cell-based therapies in the country are safe and effective for their intended use,” a DOH statement said.

The order also prohibits the use of aborted human fetal stem cells and their derivatives, and plant parts labeled as stem cells “for human treatment and research the creation of human embryos and their derivatives.”

The DOH said the guidelines are intended to prevent the “introduction, transmission and spread of communicable diseases by ensuring minimum quality of service and staff qualification rendered by hospitals and other health facilities capable of utilizing human stem cell preparations and cell-based therapies.”

“These guidelines will classify which stem cell preparations and therapies will be registered and allowed with certain restrictions. Preparations that will be allowed include those with adult human stem cells, human umbilical cord stem cells, and human organ-specific cells,” the DOH said.

The DOH order stated that health facilities utilizing stem cell preparations and cell-based or cellular therapies would have to comply with the guidelines set by the Bioethics Advisory Board.