Scientists to issue stem-cell guide

Their goal is to keep people desperate for treatment from falling prey to quacks.

The world's leading group of stem-cell researchers yesterday announced it would issue guidelines for turning basic stem-cell research into safe, effective therapies.

The International Society for Stem Cell Research's recommendations are aimed at halting "stem-cell tourism" - the growing parade of patients traveling to developing countries for costly, unproven and potentially harmful stem-cell treatments.

"They're basically selling the 'snake oil' we've seen in medical fraud for many centuries," George Q. Daley, president of the International Society for Stem Cell Research (ISSCR), said at a news conference yesterday.

The group, holding its annual meeting at the Philadelphia Convention Center, had planned to release a draft of the guidelines. But the authors decided at the last minute to make revisions - a sign of the complexity and sensitivity of the subject.

"We've gotten so much input, we decided it would be premature," said Olle Lindvall, a neurologist at Lund University in Sweden and chair of the guideline task force.

Whether potential stem-cell tourists would be swayed by guidelines remains to be seen.

Lora Lowery of Carneys Point, N.J., searched for clinical trials - carefully controlled experiments approved by the U.S. government - for her baby son, Justin, who was born blind because of underdeveloped optic nerves. When she found nothing, she began investigating stem-cell enterprises that have sprung up in China, Mexico, India, Peru, Russia and elsewhere.

'Taking a risk'

She and her husband, Jason, opted for Beike Biotechnology Co. in China. All told, they spent $70,000, including $20,000 for the umbilical-cord blood stem-cell infusions.

"If there had been guidelines, it might have made a little difference to me, but it wouldn't have made me not want to do it," Lowery said. "We knew we were taking a risk."

To some degree, whatever guidelines the ISSCR comes up with will cover familiar ground. The Food and Drug Administration already has rules for turning basic research into safe, effective therapies through clinical trials. So do most developing countries, although enforcement may be lax. Many advocacy groups also offer patient guidelines.

But existing rules were written before the world got excited about stem cells, the progenitor cells that make and fix all the tissues of the body.

Stem-cell research has exploded since 1998, when embryonic stem cells - the most versatile, powerful kind - were first isolated by destroying five-day-old embryos. So-called adult stem cells, which renew specific tissues, have since proved to be remarkably versatile as well.

Years away

Still, while stem cells are not snake oil, their therapeutic use remains years away. The only proven treatments are for blood disorders, certain cancers, and rare immune deficiencies. The few clinical trials in Western countries are mostly for treatable problems such as heart disease.

"There is a risk that patients who are desperate will misunderstand the amount of progress in the field," said Daley, associate director of the Stem Cell Program at Children's Hospital Boston. "It is fertile ground for exploitation."

That ground includes the United States. In 2006, a federal grand jury indicted a man and woman for stem-cell treatment fraud; they relocated to South Africa and changed their company's name to Advanced Cell Therapeutics.

The long list of conditions that stem-cell purveyors purport to treat - including Parkinson's, stroke, autism and paralysis - is a classic sign of quackery, critics say.

Critics also condemn the lack of published studies or data on the treatments.

So not only are potential ill effects unclear, critics say, it's also impossible to judge whether some interventions actually work in some cases.

The Lowerys - and their doctor, Jonathan Salvin - have seen significant improvement in Justin, now 13 months old. For example, he tracks toys and other objects with his eyes.

Lora Lowery attributes it to the stem-cell treatment. Salvin says there is no way to know.

"I'd be cautiously optimistic that maybe this is from the [stem cell] protocol," said Salvin, a pediatric ophthalmologist at A.I. duPont Hospital for Children. "But I have seen improvement like this in kids who haven't had this protocol."


Contact staff writer Marie McCullough at 215-854-2720 or mmcullough@phillynews.com.