Updated on 31 January 2013
Mr Gaikwad says that the possible harmful risk associated with unapproved stem cell therapies are making regulatory agencies and patients skeptical about potential of stem cell therapies, necessitating the need for controlled clinical studies to provide evidence on safety and efficacy claims of such therapies.
Unapproved stem cell therapies, claiming to treat a myriad of disease conditions, are being offered in various counties all over the world. "Each year, thousands of foreigners are arriving to APAC countries to seek stem cell therapies which they can't receive in their own countries, where clinical data on safety and efficacy of stem cell therapies are necessary for their approval. Treatment with unapproved stem cell therapies, lacking proven clinical data, can pose safety risk to the patients," he says.
However, governments and health authorities are slowly but surely waking up to the problem. Last year, the US Food and Drug Administration (FDA) warned consumers about unapproved stem cell therapies. In 2012, government of China ordered to halt unapproved stem cell treatments and clinical trials.