Rules on cell-based therapies out soon

THE Health Ministry will produce a guideline for research on stem cell and cell-based therapies with the recent formation of the National Committee on Ethics of Stem Cell Research and Therapy.

Outgoing Director-General Tan Sri Dr Mohd Ismail Merican said as cellular products, including stem cell-based therapies, were biological products that carried risks and benefits, government intervention and regulation was required to protect the public.

He said while the ministry welcomed and looked forward to documented evidence of benefits in new therapies, there was also a need to ensure that the rights, values and welfare of the donor, recipient and community were protected and respected.

"The ministry is more concerned with stem cell therapies that are still in developmental stage and these include treatment for heart failure, stroke, spinal cord injuries and organ failure.

"These experimental stem cell therapies must be approved by the institutional research and ethics committee, and the conditions must be done strictly to the context of clinical trials," he said while officiating Nichi-Asia Life Science Sdn Bhd's (NiSCELL) inauguration event recently.

Dr Ismail stressed that there must be sufficient evidence to show the level of safety, quality and efficacy of the therapy before clinical trials were conducted.

He added that centres performing stem cell or cell-based therapies must be registered with the ministry for a licence to operate.

So far, the ministry has approved five private cord blood banks and stem cell collection facilities.

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