Stem-cell treatment under scrutiny
The Food and Drug Administration cannot guarantee the safety of stem-
cell therapy treatment, its secretary-general Siriwat Tiptaradol said
yesterday.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.
http://nationmultim
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
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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