Stem cell guidelines announced

By Neil Munshi, Globe Correspondent

Worried that sham procedures are endangering patients and giving stem cells a bad name, leading researchers today announced a set of guidelines governing research and treatment.

“Because of the spotlight on stem cells, there’s been a misconception by some patients that the cure is already here,” said Dr. George Q. Daley, president of the International Society for Stem Cell Research, which issued the draft guidelines at their sixth annual meeting in Philadelphia. “We need to be clear that the path to cures is a long and arduous one…it can take years, sometimes decades, and we’re just at the beginning of that process.”

The guidelines – which will provide a basis from which patients, doctors and scientists alike can judge clinics and treatments – deal with the quality control and regulation of cell processing and manufacturing, pre-clinical studies, and clinical research.

“We have the sense that the field is moving very rapidly and stem cell science is moving ahead by leaps and bounds,” said Daley, also the associate director of the Stem Cell Program at Children’s Hospital Boston. “Yet we are concerned as stem cell scientists that there may be a misunderstanding that the clinical relevance is more advanced than it really is – and this creates a potential for the exploitation of patients.”

Doctors and scientists are seeing this, Daley said, in the proliferation of Web sites that purport to provide treatments for everything from neurodegenerative diseases like ALS and Parkinson’s to spinal cord injuries – for a price that can rise above $100,000.

“Patients should be highly suspicious if they are being asked to fly off to far off places that don’t operate under the jurisdiction of any regulatory agency,” Daley said, given that only blood stem cell transplants have demonstrated any proven treatment benefits. “When we move outside that realm, everything becomes highly experimental.”

See Gareth Cook’s Pulitzer Prize-winning reporting on stem cell tourism.