Stem-cell therapies 'unproven and giving Thailand a bad name'

"This damages the country's reputation. It will be an obstacle for scientists and researchers who conduct stem-cell studies and comply with the law," said Dr Niphan Isarasena of Chulalongkorn University's Stem Cell and Cell Therapy Unit.

Dr Niphan has attended several international stem-cell research conferences over the past year at which many scientists criticised Thailand for unproven stem-cell therapies for patients, which they said would put individuals at risk from unprecedented symptoms and complications, such as cancer, during treatment.

Some clinics and private hospital advertise that they provide stem-cell treatment to treat chronic diseases such as diabetes and heart disease. Some provide stem-cell treatment for cosmetic purposes. But these treatments were unproven as the clinical standard.

Only hematopoietic stem-cell transplants for leukemia are accepted as standard for medical treatment.

"Numerous clinics around the world are exploiting patients' hopes by purporting to offer new and effective stem-cell therapies for seriously ill patients, typically for large sums of money and without credible scientific rationale, transparency, oversight or patient protection," Dr Niphan said.

Dr Vitoon Ungpraphan, an adviser to the Medical Council of Thailand, said private hospitals and clinics that advertise and provide the unproven stem-cell treatment were violating the Health Facilities Act and people involved could be fined or go to jail.

He urged the council's committees, plus the Food and Drug Administration and Medical Registration Division, to control the hospitals, clinics and doctors providing unproven stem-cell therapies to patients.

However, as many state hospitals and private hospitals are conducting stem-cell research, Niphan said researchers should comply with the International Society for Stem Cell Research (ISSCR), which has developed guidelines for clinical translation of stem-cells and stem-cell research into appropriate clinical applications.

The guidelines suggest all studies involving clinical application of stem-cells, whether publicly or privately sponsored, be subject to independent review approval. They also call for oversight bodies to monitor ongoing research of human subjects with appropriate supplemental expertise to evaluate the unique aspects of stem-cell research and its application in a variety of clinical disciplines.

This review and oversight process must be independent of the investigators regardless of whether it occurs at an institutional, regional or national level and regardless of whether investigators employ the service of a contract research organisation.

Informed consent forms for clinical trials should include that the trial involves research and why the research is being done, what the study treatment is (in case it is a random trial), the chance of patients receiving different treatment, whether it is placebo or alternative treatment, plus what medical options there are, what is involved in the study before during and after treatment including procedures like blood, who will perform the study, and how long the study will last.

The document should not include language that releases the investigator, the institution, the sponsor or their agents from liability for negligence. And importantly, patient should not be charged during the trial.