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Stem-cell rules address safety, ethics

By Allison M. Heinrichs
Thursday, Dec. 4, 2008
 

Stem cells someday might become a magnificent cure-all, but science is not there yet and patients should be wary of a growing, global stem cell industry with savvy marketing techniques, say researchers worried about patients desperate for treatments.

Pittsburgh doctors were among an international group of stem cell scientists who published guidelines in today's issue of the journal Cell Stem Cell recommending global agreement that all treatments be independently reviewed, that results be made public and that certain ethical standards, such as informed consent, be followed.

"We don't want to slow the field down," said Dr. Ira Fox, co-author of the guidelines and stem cell scientist at the University of Pittsburgh McGowan Institute for Regenerative Medicine. "But we want to make sure that it is safe and careful and ethical."

The International Society for Stem Cell Research established the guidelines.

"These guidelines are not novel, and I wouldn't say they're extreme," said Dr. Peter Rubin, who researches adult stem cells at the McGowan Institute. "These guidelines are basically the guidelines under which most human research is conducted in the United States under federal law."

A separate analysis of Web sites touting stem cell therapies accompanied the guidelines. For the most part, the Web sites touted their treatments as "safe, effective, and ready for routine use in a wide variety of conditions," but published data do not back the claims, according to the analysis.

Almost every day, Burhan Gharaibeh, manager of the Stem Cell Research Center lab in Children's Hospital of Pittsburgh, fields calls from people hopeful about stem cell treatments they've read about on the Internet.

"Unfortunately ... they have this misconception that there is a solution to this particular problem that they have," said Gharaibeh, also a scientist in Pitt's Department of Orthopedic Surgery. "Often I have to stop them and say, 'Listen, that just isn't the case.' "

He tells them they need to make sure they enroll in clinical trials that have federal oversight, and are transparent with the risks and results of treatment. In general, trials offered in the United States and Western Europe fit that criteria, he said.

When Jessie Fend read about a stem cell treatment for blindness being offered in China she was skeptical, but couldn't shake the feeling that such a treatment could help her son, Cody, 3, who was born with optic-nerve hypoplasia. His optic nerves did not form correctly, leaving him blind, and he could perceive only light and dark.

"There were 16 kids who had already had this done and most of them were from the United States," said Fend, of Butler. "So I linked up with all of the families. We wanted to know what happened with their children. The younger kids had more significant improvements, but every single case had some improvements in their vision."

The only downside Fend could find was a slight fever and flu-like symptoms in a few of the children and those cleared up in a few days, she said. So she and her husband raised $60,000 and took Cody to Qingdao, China, for the treatments offered by Beike Biotechnology.

In the month they were there, Cody received five injections of stem cells harvested from donated umbilical cord cells. Four were done through spinal punctures and one was intravenous.

"After the first spinal we noticed a difference," Fend said. "It was really amazing. ... He was a whole different kid. All of the sudden he had more energy, he was more active, more focused."

Cody can distinguish among colors and make out shapes, but remains clinically diagnosed as blind. Next year, his parents plan to return with him to China for more treatment.

Gharaibeh said he couldn't comment on Cody's case specifically, but risks of such a treatment include severe rejection of the stem cells and cancerous tumors.

Clinics like Beike Biotechnology do not meet the voluntary guidelines, but the International Society for Stem Cell Research is hopeful that governments of countries where such clinics are located use the guidelines to create more stringent laws.

"You can't make people do what they don't want to do," Fox said. "We all know that there are business advantages, and when you get stem cell tourism, it brings money into the country.

"But international pressure can do a lot to sway a government," he said. "And for the scientists at these clinics, we can say to them, 'If, in fact, you are performing such studies and you're not following the guidelines, then we're not going to invite you to our meeting to present your data.' "

 

 
 


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