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Published on September 21, 2007

The meetings will cover in much greater detail the requirements for stem cell products that could be launched in the future, particularly their quality for use with humans, secretary-general Siriwat Tiptaradol said yesterday.

The manufacturers must conduct research, lab tests, and animal and clinical trials to certify their products' quality for use in humans and safety for treatment.

The process of collecting stem cells must also adhere to safety standards under good tissue practice regulations.

The FDA also will discuss the registration of stem cell products and steps to follow up their injection into the human body.

The FDA will hold two more meetings and will be open for all stakeholders to give recommendations before the Public Health Ministry issues the regulations as a ministerial directive within six months.

Dr Somsak Lohlekha, president of the Medical Council of Thailand, said after the FDA sets up a committee to oversee and control stem cell treatment and research, the council would gain the authority to control all hospitals and medical institutes. If they want to conduct stem cell research they must seek prior approval from the council.

"At present most hospitals particularly private hospitals have set up committees to approve their research by themselves. No one has the authority to monitor their research for proper procedures or harm to patients," he said.

Scientists from Mahidol University have issued warnings to the public about using stem cells for treatment or even cosmetic care.

Dr Touch Ativitavas of Ramathibodi Hospital said most scientific studies, which are published in international medical journals like Lancet or the New England Medical Journal, could not guarantee the use of stem cells as standard treatment.

Some trials had been reported as helping some patients for only a short period or showing little benefits for patients.

He expressed concern about the efficacy of using animal stem cells as cosmetic treatment, particularly those from pigs and sheep.

Human antibodies would destroy animal stem cells after they were injected due to the natural immune mechanism of the human body.

 Pongphon Sarnsamak

 The Nation