PREMATURE use of stem-cell therapy could put patients at risk of viral or prion infections, such as “mad cow” disease, unless stringent safety measures are in place, scientists have said.

Experts in stem-cell research gave warning yesterday in the British Medical Journal that patients receiving donor stem cells are at risk of contracting contagious diseases and suggested that stem-cell lines should be tested for certain pathogens.

Peter Braude, a professor of obstetrics and gynaecology at King’s College London, Stephen Minger, the director of its stem-cell biology laboratory, and Ruth Warwick, a consultant haematologist at the National Blood Service, said that scientists should heed the lessons of previous premature applications of innovative therapies.

Recent experiences with gene therapy, the devastation caused by HIV transmission to people with haemophilia and the crisis caused by bovine spongiform encephalopathy (BSE), commonly known as “mad cow” disease, should all be learning opportunities, they said.

“Expansion of stem-cell cultures could allow a single stem-cell line to be used for many hundreds, if not thousands of patients, exponentially amplifying the potential risk of disease transmission from an infected donor,” they said. They gave warning that without appropriate controls the drive by scientists to be the first to produce cell lines for therapy could compromise safety and lead this technology into the realms of quackery.

By April 2006 laboratories for in-vitro fertilisation and the production of cell lines for therapy will have to comply with strict regulations set out in an EU directive on tissues and cells. This will cover the selection of donors, testing and procurement of the starting material for cell lines, tracking cells from donor to recipient and the reporting of adverse events.

The authors suggest that the expanded stem-cell lines should also be tested for a variety of pathogens before they are released, providing an additional safeguard. “Stem-cell therapy needs to be nurtured safely and methodically to provide real benefit to patients in the future,” they said.

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