Dec. 3 (Bloomberg) -- Renegade stem-cell scientists are victimizing desperate patients by promoting treatments without properly citing risks and inflating results, spurring the need for global guidelines, researchers said today.

Unproven treatments should be offered only to patients in research trials that evaluate safety and effectiveness, according to guidelines issued today by the International Society for Stem Cell Research. The trials should be independently reviewed, disclose all risks and occur only after lab and animal tests are completed, the recommendations said.

The guidelines were published today in the journal Cell Stem Cell, along with a separate analysis of the Web sites of clinics worldwide promoting stem cell treatments. That report found the sites provided little information about risks and made “optimistic” and “inaccurate claims” about treatments.

“We’re worried about patients and we are worried about the field,” said George Daley, a researcher at the Harvard Stem Cell Institute and member of the task force that wrote the guidelines, in a telephone interview yesterday. “The field is at risk from renegade, illegitimate practitioners. If there is a public perception that the science isn’t being done carefully then we’re at risk for losing public support.”

Global Consultations

The guidelines were drafted during the past year by a task force of 30 scientists from 13 countries. Task force members consulted with regulators and researchers around the world. The International Society is a nonprofit organization of doctors that holds an annual meeting that last year drew 2,500 researchers, according to the group’s Web site.

The goal is to provide a “road map to the clinic” that researchers, institutions and regulators should follow as they prepare to begin testing promising therapies in patients, said Olle Lindvall, a neurologist at the University of Lund in Sweden and task force member.

All research trials should be reviewed by ethical oversight boards and complete results should be made public, the guidelines say. Government regulatory bodies should oversee human use of stem call-based therapies and should be established in countries that don’t already have them.

Stem cells are like blank slates that have the ability to form other kinds of cells. Embryonic stem cells can form any of the body’s approximately 210 cell types while so-called adult stem cells, found in the mature tissues of living people or animals, have a more limited potential. Because of their flexibility, scientists are studying ways to use stem cells to repair or replace tissue damaged by disease or injury.

Rare Cases

The research guidelines suggest it may be appropriate in rare cases to offer experimental treatment to a small number of seriously ill patients who aren’t in a formal clinical trial.

When “medical innovation” of this kind occurs, the treating doctor should outline the rationale for the therapy and why it’s likely to be more effective than standard treatments. Plans to deal with side effects also should be noted. The proposed treatment should be reviewed by independent monitors and lead to formal research trials, the task force said.

“Stem cell research holds tremendous promise for the development of novel therapies but it will require time and effort,” Lindvall said yesterday in a telephone interview.

The report on Internet promotion of therapies reviewed 19 clinics offering stem cell treatments in various countries for conditions such as Parkinson’s disease, stroke, Alzheimer’s, spinal cord injury and heart disease. It found the description of the therapies to be “optimistic and unsubstantiated by peer- reviewed literature.”

Risks Underpublicized

The report, from researchers at the University of Alberta in Canada, found that while every clinic Web site outlined how the therapy could improve a patient’s condition, only one-quarter mentioned risks involved in the treatments. Few studies have been published supporting the kinds of treatments being offered and many of them were of poor quality, the Alberta team found.

“If you look at the relevant peer-reviewed literature, as we did, it seems highly unlikely that patients are being helped,” said Timothy Caulfield, research director of the university’s Health Law Institute and the study’s lead author, in an e-mail yesterday. “If they are being helped, let us see the data.”

One of the clinic operators, Beike Biotechnology Co., said it has treated more than 3,000 patients for various neurological conditions in 24 hospital-based clinics across China, the report noted. The Web site, beikebiotech.com, claims “70 to 80 percent of patients are satisfied with their treatment.”

Most of the Web sites didn’t discuss the cost of the treatment, the researchers said. Among four sites that did, the average cost for the therapy was $21,000 not including travel and lodging.

Sean Hu, chairman of Beike Biotechnology, didn’t respond to the allegations leveled by the report after being reached by telephone.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.

Last Updated: December 3, 2008 13:10 EST