National body to guide clinical trials, therapies
APIRADEE TREERUTKUARKUL
After years of doubts about the benefits of using stem cell technology and standards, the Medical Council of Thailand has drawn up regulations controlling clinical trials, therapies and advertising. Council president Dr Somsak Lohlekha said an academic panel would be set up to oversee clinical trials using stem cells.
The panel would decide if stem cell trials at different medical schools and hospitals meet scientific and ethical standards.
At present, each stem cell study need only be approved by an ethics committee at the hospital where the trial is being made, Dr Somsak said.
There is no national regulatory body overseeing the task, raising questions about the ethics and standards of stem cell research and the application of stem cell therapies in Thailand, he said.
Under the draft regulation, which must be approved by the Public Health Ministry, the panel would consist of experts on stem cell technology from medical universities as well as representatives from the Medical Council, Public Health Ministry and the Food and Drug Administration.
The panel would scrutinise stem cell study proposals. Only soundly researched results with proof the treatment could prolong a patient's life would be approved for use, Dr Somsak said.
Stem cells are found in most multi-cellular organisms and can be grown and transformed into specialised cells.
Stem cell technologies are widely used for treating ailments such as heart disease, Parkinson's disease, diabetes and neurological diseases.
However, stem cell therapy has been scientifically proven successful only for leukaemia and thalassemia. Its use in treating other chronic diseases is still experimental.
Dr Somsak said regulation would protect patients from exaggerated advertising about stem cell therapy.
He expected the ministry to approve the regulation and that it would be put it into effect within three months.
Prasert Palittapongarnpim, a stem cell specialist at Chiang Rai Prachanukroh hospital, agreed with the need for the setting up of a national body to oversee stem cell trials and protect patients.
But he questioned if it would be free of the influence of the thriving stem cell business.
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