The Department of Health (DOH) on Saturday warned those contemplating stem cell therapy against using stem cells from aborted babies and human embryos.
The DOH issued the statement as it reviewed the legal and technical specifications of stem cell therapy to come up with a regulatory framework.
“The Philippine government will not allow the use of aborted fetuses or human embryos (as sources of stem cells). There is a need to ensure that the biological raw materials are documented and validated and follow infection-free procedures,” the health department said.
“There is also a need to know if the materials to be injected came from animal or human tissues,” it added.
The DOH said the other “fundamental areas” of the regulatory framework would include the monitoring of the “marketing claims” by medical centers that offer stem cell therapy “so that the claims stick within the boundaries of science as objectively as possible.”
Credentials and procedures
The credentials of the scientists involved should also match the training, education and skills required for these procedures while good laboratory procedures should be observed in the preparation of the tissue and cells, the DOH said.
“The centers to be regulated or accredited will have to show both positive and negative outcomes for a better handle of the predictors of success or failure from this intervention,” it said.
The health department said there was a need for a regulatory framework because there were many steps in the preparation of stem cell therapies and the government had been receiving many queries about it.
“Important questions were asked like ‘Is there proof of a concept in animal trials where stem cells can be applied in humans? Is there a way to ensure the quality and purity of the raw materials? How safe is the procedure? How many did not benefit from the procedure? If this were an investigation procedure, how will human subjects be protected?” it said.
The DOH said it had created a regulatory task force to oversee the steps that would ensure the quality, efficacy and safety documentation of stem cell therapy in the country.