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Published on July 18, 2007

"Right now the use of stem cells for treatment should be under the auspices of a doctor - and that doctor's medical ethics - because there is no regulation that allows the FDA to test stem-cell material before it is used on a patient. Therefore, the FDA cannot guarantee this type of treatment" Siriwat said.

Stem-cell therapy is the newest medical innovation to treat patients who have chronic diseases like diabetes. Hospitals around the world are seeking solutions to control the treatment.

Siriwat said the biggest issues in stem-cell therapy were the medical practices and procedures involved and the ethics behind its use. The Medical Council must control the hospitals and clinics using stem-cell treatment, he said.

However, he said the regulations for stem-cell treatment were still being considered by a committee set up by the FDA. The committee will meet again next month.

The committee members are doctors and experts in cell therapy from the Faculty of Medicine at Chulalongkorn University, Ramathibodi and Siriraj Hospitals, the Medical Council, and the Department of Medical Science.

They are deliberating on whether stem cells should be classified as a controlled bio-material - along with blood and vaccine.

"I admit that drafting the stem-cell treatment regulations is more difficult than drug regulations, because it is not necessary to register [stem cells] with the FDA before use on a patient. And, moreover, there are various sources of stem cells from patients, donors and imports, so it is difficult to control," Siriwat said.

Dr Amnaj Kussalanan, the Medical Council secretary-general, said the Medical Council would investigate stem-cell treatments in hospitals to see if they were being provided under medical standards and ethics. Anyone with information about hospitals or clinics using the controversial treatment should contact the Medical Council.

Dr Prasopsri Ung-thavorn, vice president of the Medical Council, said regulations would be announced in the government gazette. After, all doctors offering stem-cell treatment for patients must practise under the listed medical standards.

Dr Tares Kassanai, director of the Public Health Ministry's Registration Division, said the authority was now considering draft regulations and standards for stem-cell therapy from human placentas. The Public Health Ministry must take action to control this service and stem-cell "banking" in private clinics or hospitals.

Duangkamon  Sajirawattanakul

The Nation