Published on July 19, 2007
Monnipha Sila-art, head of Mahidol University's Cell Engineering and Tissue Growth Laboratory, said yesterday the trial project would be moved forward as it had been approved by ethics committees of both the Public Health Ministry and Wat Rai Khing Hospital.
"The committees considered that the trial is safe for patients," she said.
She admitted that she had not conducted animal tests before moving the trial to humans.
Monnipha recently claimed she had succeeded in developing limbal cells from stem cells extracted from skin cells.
She then informed the Health Ministry that she wanted to complete her research by conducting the trial on human beings.
The ministry then agreed to allow the trial to be conducted on 10 patients at Metta Pracharak Hospital, widely known as Wat Rai Khing Hospital, which specialises in eye problems, Monnipha
Since being introduced earlier this month, the trial project, funded by the National Research Council, has been criticised by a group of experts who say it is premature to conduct trials for stem-cell therapy for patients with eye diseases.
Dr Nipan Isarasena, head of the stem-cell unit at Chulalongkorn Hospital, said he had never heard of any successful case of developing limbal cells from skin cells, not to mention any success in replacing such cells in patients or in animals.
"It would be the pride of the nation if the team have really done it," he said.
Nipan expressed doubt because the team had not publicised its claimed success - which would otherwise be considered as a significant breakthrough.
Monnipha countered that she plans to announce the success once the clinical trial is complete.
"We don't want researchers in other countries to hijack our techniques," she said.
Monnipha admitted that not many other countries had dared to conduct stem-cell therapy trials on patients with eye diseases, particularly by using cells extracted from other parts of the patients' bodies.
"In developed countries, doctors have faced legal cases filed by patients and relatives. In many of these cases doctors have lost and been forced to pay compensation. But in Thailand, as we have seen, whenever there is a case, doctors usually win," she said.
However, the researcher insisted that if any negative medical reaction happened to a patient receiving the trial treatment and if it was proved to be linked to the treatment, she and the doctors involved in the trial would take responsibility.